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BHU-DRA/ER/B05034
Essential/Non essentialScheduleRegistration Type*Application Type*Market Authorisation HolderCategory of Medical Product*This product is intended for*Generic Name*Brand NameDosage Form*Pack Size*Type of Packaging*Composition of active ingredients with strengths*Manufacturer*MarketerCountry of Manufacturer*Therapeutic CategoryCertificate NumberIssue DateExpiry Date
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1Non Essential MedicineBExpedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseProchlorperazine Maleate I.P...5mgStemetil® MD TabletTablet25 x 2 x 10 TabletsStripEach uncoated mouth dissolving tablet contains: Prochlorperazine Maleate I.P...5mgAbbott India Limited.IndiaAntipsychoticsBHU-DRA/ER/B0509217-Mar-2017-Mar-2023
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2Non Essential MedicineA1Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseLoratadine USP...5mgORADIN SuspensionSuspension60 mlAmber Glass BottleEach 5 ml contains: Loratadine USP...5mgESKAYEF BANGLADESH LIMITEDBangladeshAntiallergics and medicines used in anaphylaxisBHU-DRA/ER/B0509017-Mar-2017-Mar-2023
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3Essential MedicineA1Full RegistrationGeneric Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseCetirizine Hydrochloride BP...10mgNOSEMIN TabletsTablet10 x 10 TabletsAlu-PVC BlisterEach film coated tablet contains: Cetirizine Hydrochloride BP...10mgThe IBN SINA Pharmaceutical Industry Ltd., Shafipur, Kaliakoir, Gazipur, Bangladesh.BangladeshAntiallergics and medicines used in anaphylaxisBHU-DRA/B0509117-Mar-2017-Mar-2023
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4Essential MedicineA1Expedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseCetirizine Dihydrochloride BP...10mgCetrigen TabletTablet1000 TabletsHDPE ContainerEach film coated tablet contains: Cetirizine Dihydrochloride BP...10mgHolden Medical Laboratories Pvt. Ltd. Nashik-422 113, IndiaIndiaAntiallergics and medicines used in anaphylaxisBHU-DRA/ER/B0508917-Mar-2017-Mar-2023
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5Non Essential MedicineBExpedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseCholecalciferol IP…….. 60000 IU(In nano Droplet form)In a flavoured sugar free base…q.s., Excipients...q.sArachitol Nano Solution.Solution2 x 5 mlAmber coloured bottleEach 5 ml syrup contains: Cholecalciferol IP…….. 60000 IU(In nano Droplet form)In a flavoured sugar free base…q.s., Excipients...q.sPULSE Pharmaceuticals Pvt. LtdIndiaVitamins and mineralsBHU-DRA/ER/B0508811-Mar-2011-Mar-2023
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6Non Essential MedicineBExpedited Registration Generic Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseSildenafil Citrate equivalent to Sildenafil...100mgORFORCE 100 TabletTablet1 x 4 TabletsAlu-PVC BlisterEach film coated tablet contains: Sildenafil Citrate equivalent to Sildenafil...100mgORBIT PHARMACEUTICALS., Ahmedabad, IndiaIndiaMedicines for erectile dysfunctionBHU-DRA/ER/B0508611-Mar-2011-Mar-2023
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7Essential MedicineA1Full RegistrationGeneric Drug ApplicationParuna Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseParacetamol IP…500mg, Excipients…q.sPOLYMOL TabletsTablet20x15 TabletsAlu-PVC BlisterEach uncoated tablet contains: Paracetamol IP…500mg, Excipients…q.sSCOTT-EDIL PHARMACIA, Himachal Pradesh, India.IndiaNon-opioid AnalgesicsBHU-DRA/B0508511-Mar-2011-Mar-2023
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8Essential MedicineBFull RegistrationGeneric Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseOmeprazole Sodium BP Eq. to Omeprazole…40mgAUDURAS InjectionPowder for Injection1 VialVialEach vial contains: Omeprazole Sodium BP Eq. to Omeprazole…40mgAccelius Global, Gujarat, India.IndiaAntiulcerBHU-DRA/B0508411-Mar-2011-Mar-2023
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9Non Essential MedicineBExpedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UsePinus roxburghil...10mg, Vitamins: Vitamin C...40mg, Vitamin B3...12mg,Vitamin E...10mg, Vitamin B5...5mg, Vitamin B6...2mg, Vitamin B2...1.1mg, Vitamin B1...1mg, Vitamin A...600mcg, Folic acid...100mcg, Biotin...30mcg, Vitamin B12...1mcg, Minerals: Zinc...10mg, Manganese...2mg, Copper...0.9mg, Selenium...40mcgBecomax® C ForteTablet15 x 15 N TabletsStripEach serving per film coated tablet contains (approx.): Pinus roxburghil...10mg, Vitamins: Vitamin C...40mg, Vitamin B3...12mg,Vitamin E...10mg, Vitamin B5...5mg, Vitamin B6...2mg, Vitamin B2...1.1mg, Vitamin B1...1mg, Vitamin A...600mcg, Folic acid...100mcg, Biotin...30mcg, Vitamin B12...1mcg, Minerals: Zinc...10mg, Manganese...2mg, Copper...0.9mg, Selenium...40mcgTirupati Lifesciences, Nahan Road, Paonta Sahib, Dist. Sirmour (H.P.) - 173 025, India.IndiaVitamins and mineralsBHU-DRA/ER/B0508711-Mar-2011-Mar-2023
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10Essential MedicineBFull RegistrationGeneric Drug ApplicationVetline Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseFluconazole IP…150mg, Excipients…q.sFLEZIS-150Tablet20x1x1Alu-PVC BlisterEach uncoated tablet contains: Fluconazole IP…150mg, Excipients…q.sGrampus Laboratories, Johron, Kalaamb, Sirmour (HP), IndiaIndiaAntifungalBHU-DRA/B0508311-Mar-2011-Mar-2023
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11Essential MedicineA1Full RegistrationGeneric Drug ApplicationParuna Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseSilver Sulphadiazine I.P...1%w/w, Chlorhexidine Gluconate Solution I.P eq. To Chlorhexidine Gluconate...0.6% w/w, In a cream base...q.sBURN NIL CreamCream50 gCollapsible Lami tubeComposition: Silver Sulphadiazine I.P...1%w/w, Chlorhexidine Gluconate Solution I.P eq. To Chlorhexidine Gluconate...0.6% w/w, In a cream base...q.sSCOTT-EDIL PHARMACIA, Himachal Pradesh, India.IndiaAntibacterialBHU-DRA/B0507810-Mar-2010-Mar-2023
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12Non Essential MedicineA1Expedited Registration Generic Drug ApplicationParuna Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UsePromethazine Hydrochloride I.P...5mg, Flavoured Syrupy Base...q.sORBIPRO SyrupSyrup60 mlAmber coloured bottleEach 5 ml contains: Promethazine Hydrochloride I.P...5mg, Flavoured Syrupy Base...q.sORBIT PHARMACEUTICALS., Ahmedabad, IndiaIndiaAntiallergics and medicines used in anaphylaxisBHU-DRA/ER/B0506810-Mar-2010-Mar-2023
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13Non Essential MedicineA1Full RegistrationGeneric Drug ApplicationParuna Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UsePovidone-Iodine I.P...5%w/w(available Iodine 0.5% w/w), Water-soluble ointment base...q.sPOVIMAX OintmentOintment20 gCollapsible Lami tubeComposition: Povidone-Iodine I.P...5%w/w(available Iodine 0.5% w/w), Water-soluble ointment base...q.sSCOTT-EDIL PHARMACIA, Himachal Pradesh, India.IndiaAntisepticsBHU-DRA/B0507710-Mar-2010-Mar-2023
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14Essential MedicineBExpedited Registration Generic Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UsePhenytoin Sodium IP … 100 mg, Excipients…Q.SORBITOIN TabletsTablet100 TabletsHDPE JarEach film coated tablet contains: Phenytoin Sodium IP … 100 mg, Excipients…Q.SORBIT PHARMACEUTICALS., Ahmedabad, IndiaIndiaAnticonvulsant/ AntiepilepticsBHU-DRA/ER/B0507610-Mar-2010-Mar-2023
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15Non Essential MedicineBExpedited Registration Generic Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseMetoclopramide Hydrochloride I.P. Equivalent to Anhydrous Metoclopramide Hydrochloride...5mgORAMIDE SyrupSyrup30 mlAmber coloured bottleEach 5ml contains: Metoclopramide Hydrochloride I.P. Equivalent to Anhydrous Metoclopramide Hydrochloride...5mgORBIT PHARMACEUTICALS., Ahmedabad, IndiaIndiaAntiemeticBHU-DRA/ER/B0506910-Mar-2010-Mar-2023
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16Essential MedicineA1Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseDried Ferrous Sulfate USP...150 mg, Folic Acid...500 mcgFEOFOL CapsulesCapsule90 CapsulesAlu-PVDC BlisterEach timed release capsule contains: Dried Ferrous Sulfate USP...150 mg, Folic Acid...500 mcgESKAYEF BANGLADESH LIMITEDBangladeshVitamins and mineralsBHU-DRA/ER/B0507410-Mar-2010-Mar-2023
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17Non Essential MedicineA1Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseFerric Ammonium Citrate I.P...160mg, (equivalent to Elemental Iron 32.8mg), Cyanocobalamin I.P....7.5mcg, Folic Acid I.P...0.5mg, Alcohonol(95%) I.P...0.87mLDEXORANGE SyrupSyrup200 mlAmber Glass BottleEach 15ml (one tablespoonful) contains: Ferric Ammonium Citrate I.P...160mg, (equivalent to Elemental Iron 32.8mg), Cyanocobalamin I.P....7.5mcg, Folic Acid I.P...0.5mg, Alcohonol(95%) I.P...0.87mLSTP PHARMACEUTICALS PVT LTD. Sangkhola, Singtam, East SIKKIM -737 134, SIKKIMIndiaVitamins and mineralsBHU-DRA/ER/B0507510-Mar-2010-Mar-2023
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18Essential MedicineBExpedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseGlycerin I.P...85% w/wn/aSuppository4g x 50 SuppositoriesHDPE JarComposition: Glycerin I.P...85% w/wArora Pharmaceuticals Pvt. Ltd.IndiaLaxativesBHU-DRA/ER/B0506710-Mar-2010-Mar-2023
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19Non Essential MedicineA1Full RegistrationGeneric Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UsePart I: Each 1000mL contains: Potassium Chloride I.P...6.00gms, Magnesium Chloride I.P...3.70gms, Calcium Chloride I.P...8.10gms, Sodium Chloride I.P...178.50gms, Glacial Acetic Acid B.P...9.46gms, Purified water I.P...Q.S Part II: Each 1000mL contains: Sodium Bicarbonate I.P...59.20gms, Sodium Chloride I.P...23.50gmsn/aSolution and Powder10 Litres CanHDPE jar and SachetComposition: Part I: Each 1000mL contains: Potassium Chloride I.P...6.00gms, Magnesium Chloride I.P...3.70gms, Calcium Chloride I.P...8.10gms, Sodium Chloride I.P...178.50gms, Glacial Acetic Acid B.P...9.46gms, Purified water I.P...Q.S Part II: Each 1000mL contains: Sodium Bicarbonate I.P...59.20gms, Sodium Chloride I.P...23.50gmsAtlantic Biomedical Pvt. Ltd.IndiaVitamins and mineralsBHU-DRA/B0508110-Mar-2010-Mar-2023
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20Essential MedicineA1Full RegistrationGeneric Drug ApplicationParuna Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseCetirizine Hydrochloride I.P...10mg, Excipients...q.sCetifarTablet10 x 10 TabletsAlu-PVC BlisterEach film coated tablet contains: Cetirizine Hydrochloride I.P...10mg, Excipients...q.sSCOTT-EDIL PHARMACIA, Himachal Pradesh, India.IndiaAntiallergies and medicines used in anaphylaxisBHU-DRA/B0507910-Mar-2010-Mar-2023
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21Essential MedicineBFull RegistrationGeneric Drug ApplicationParuna Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseCeftriaxone Sodium (sterile) USP eq. To Ceftriaxone Anhydrous...1000mgVELXONE-1 Injectionpowder for injection with Diluent1 gmVial and ampoule(diluent)Each vial contains: Ceftriaxone Sodium (sterile) USP eq. To Ceftriaxone Anhydrous...1000mgVellinton Healthcare, Sirmour, India.IndiaAntibacterialBHU-DRA/B0508210-Mar-2010-Mar-2023
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22Essential MedicineBExpedited Registration Generic Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseCalcium lactate I.P...300mgORBILACTATE 300 TabletTablet100 TabletsHDPE JarEach uncoated tablet contains: Calcium lactate I.P...300mgORBIT PHARMACEUTICALS., Ahmedabad, IndiaIndiaVitamins and mineralsBHU-DRA/ER/B0507110-Mar-2010-Mar-2023
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23Non Essential MedicineBExpedited Registration Generic Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseBeclomethasone Dipropionate I.P 0.025%w/w, Phenylephrine Hydrochloride I.P 0.1%w/w, Lignocaine Hydrochloride I.P 2.50%w/w, Chlorocresol I.P 0.1%w/wANORBIT OintmentOintment15 gmCollapsible Lami tubeComposition: Beclomethasone Dipropionate I.P 0.025%w/w, Phenylephrine Hydrochloride I.P 0.1%w/w, Lignocaine Hydrochloride I.P 2.50%w/w, Chlorocresol I.P 0.1%w/wORBIT PHARMACEUTICALS., Ahmedabad, IndiaIndiaSteroidal Anti-inflammatoryBHU-DRA/ER/B0507010-Mar-2010-Mar-2023
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24Essential MedicineBFull RegistrationGeneric Drug ApplicationParuna Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseAllopurinol I.P...100mg, Excipients...q.sZYLOTIS-100 TabletsTablet10 x 10 TabletsAlu-PVC BlisterEach uncoated tablet contains: Allopurinol I.P...100mg, Excipients...q.sSCOTT-EDIL PHARMACIA, Himachal Pradesh, India.IndiaAntigoutBHU-DRA/B0508010-Mar-2010-Mar-2023
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25Essential MedicineBExpedited Registration Generic Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseAcyclovir I.P...400 mgOROVIR 400 TabletTablet100 TabletsHDPE JarEach uncoated tablet contains: Acyclovir I.P...400 mgORBIT PHARMACEUTICALS., Ahmedabad, IndiaIndiaAntiviralBHU-DRA/ER/B0507210-Mar-2010-Mar-2023
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26Essential MedicineBExpedited Registration Generic Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseAciclovir IP…5.0% w/w, In a Cream Base...q.s.ORCLOVIR CreamCream5 gmCollapsible Lami tubeComposition: Aciclovir IP…5.0% w/w, In a Cream Base...q.s.ORBIT PHARMACEUTICALS., Ahmedabad, IndiaIndiaAntiviralBHU-DRA/ER/B0507310-Mar-2010-Mar-2023
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27Non Essential MedicineA1Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseOxymetazoline Hydrochloride USP...0.25mg in a buffered aqeous solutionSinarest-PD Nasal DropsNasal drops10 mlLupolene vialEach ml contains: Oxymetazoline Hydrochloride USP...0.25mg in a buffered aqeous solutionCentaur Pharmaceuticals Pvt. Ltd., Santacruz(E0,Mumbai 400 055 IndiaIndiaNasal DecongestantBHU-DRA/ER/B0506025-Feb-2024-Feb-2023
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28Essential MedicineBExpedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseLosartan Potassium IP...25mgLosatrust 25 TabletTablet10 x 10 TabletsAlu-PVC BlisterEach film coated tablet contains: Losartan Potassium IP...25mgCentaur Pharmaceuticals Pvt. Ltd., Santacruz(E0,Mumbai 400 055 IndiaIndiaAntihypertensiveBHU-DRA/ER/B0505925-Feb-2024-Feb-2023
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29Non Essential MedicineBExpedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseLosartan Potassium IP...50mg, Hydrochlorthiazide IP...12.5mgLosatrust - H TabletTablet10 x 10 TabletsAlu-PVC BlisterEach film coated tablet contains: Losartan Potassium IP...50mg, Hydrochlorthiazide IP...12.5mgCentaur Pharmaceuticals Pvt. Ltd., Santacruz(E0,Mumbai 400 055 IndiaIndiaAntihypertensiveBHU-DRA/ER/B0505825-Feb-2024-Feb-2023
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30Essential MedicineBExpedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseFluconazole BP...150mgFLUCONAZOLE 150 mg TabletsTablet3 x 4 TabletsAlu-Alu BlisterEach tablet contains: Fluconazole BP...150mgThe ACME Laboratories Ltd., Dhaka, Bangladesh.BangladeshAntifungalBHU-DRA/ER/B0506325-Feb-2024-Feb-2023
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31Essential MedicineBExpedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseMiconized fenofibrate BP...200mgLIPIDOF 200 CapsuleCapsule2 x 10 CapsulesAlu-PVC BlisterEach capsule contains: Miconized fenofibrate BP...200mgThe ACME Laboratories Ltd., Dhaka, Bangladesh.BangladeshLipid-lowering agentsBHU-DRA/ER/B0506425-Feb-2024-Feb-2023
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32Essential MedicineBExpedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseAspirin BP...75mgECOSPRIN 75 TabletsTablet10 x 10 TabletsStripEach enteric coated tablet contains: Aspirin BP...75mgThe ACME Laboratories Ltd., Dhaka, Bangladesh.BangladeshAntithromboticBHU-DRA/ER/B0506225-Feb-2024-Feb-2023
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33A1Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseMagnesium Hydroxide I.P...185mg(added as paste), Simethicone I.P...50mg, Sodium carboxymethylcellulose I.P...100mg, Dried Alumiminium Hydroxide Gel I.P...830mg (addes as paste)DIGENE (Mint Flavour)Gel200mLPET BottleEach 10mL (two teaspoonfuls approx.) contains: Magnesium Hydroxide I.P...185mg(added as paste), Simethicone I.P...50mg, Sodium carboxymethylcellulose I.P...100mg, Dried Alumiminium Hydroxide Gel I.P...830mg (addes as paste)Abbott India Limited.IndiaAntiulcerBHU-DRA/ER/B0506125-Feb-2024-Feb-2023
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34A1Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseMagnesium Hydroxide I.P...185mg (added as paste), Simethicone I.P...50mg, Sodium Carboxymethylcellulose I.P...100mg, Dried Aluminum Hydroxide Gel I.P...830mg (added as paste)DIGENE® Mixed Fruit Flavour GelGel200 mlPET BottleEach 10 ml (2 teaspoonfuls approx.) contains: Magnesium Hydroxide I.P...185mg (added as paste), Simethicone I.P...50mg, Sodium Carboxymethylcellulose I.P...100mg, Dried Aluminum Hydroxide Gel I.P...830mg (added as paste)Abbott India Limited.IndiaAntiulcerBHU-DRA/ER/B0506625-Feb-2024-Feb-2023
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35BExpedited Registration Generic Drug ApplicationKuenphen Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseAmoxicillin Trihydrate USP eq. To Amoxicillin...500mg, Diluted Potassium Clavulonate BP eq. To Clavulonic Acid...125mgJOYCLAV-625 TabletTablet1 x 10 TabletsAlu-Alu BlisterEach film coated tablet contains: Amoxicillin Trihydrate USP eq. To Amoxicillin...500mg, Diluted Potassium Clavulonate BP eq. To Clavulonic Acid...125mgMalik Lifesciences Pvt. Ltd.,IndiaAntibacterialBHU-DRA/ER/B0505725-Feb-2024-Feb-2023
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36Essential MedicineBExpedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseAcetazolamide BP...250mgACEMOX TabletsTablet10 x 10 TabletsStripEach tablet contains: Acetazolamide BP...250mgThe ACME Laboratories Ltd., Dhaka, Bangladesh.BangladeshDiureticsBHU-DRA/ER/B0506525-Feb-2024-Feb-2023
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37A1Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseDried Aluminium Hydroxide Gel I.P...300mg, Magnesium Aluminium Silicate Hydrate...50mg, Magnesium Hydroxide I.P...25mg, Simethicone I.P...25mgDigene® Orange Flavour TabletTablet90 x 15 TabletsAlu-PVC BlisterEach uncoated chewable tablet contains: Dried Aluminium Hydroxide Gel I.P...300mg, Magnesium Aluminium Silicate Hydrate...50mg, Magnesium Hydroxide I.P...25mg, Simethicone I.P...25mgAbbott India Limited.IndiaAntiulcerBHU-DRA/ER/B0505510-Feb-209-Feb-2023
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38A1Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseDried Aluminium Hydroxide Gel I.P...300mg, Magnesium Aluminium Silicate Hydrate...50mg, Magnesium Hydroxide I.P...25mg, Simethicone I.P...25mgDIGENE® Mint Flavour TabletTablet90 x 15 TabletsAlu-PVC BlisterEach uncoated chewable tablet contains: Dried Aluminium Hydroxide Gel I.P...300mg, Magnesium Aluminium Silicate Hydrate...50mg, Magnesium Hydroxide I.P...25mg, Simethicone I.P...25mgAbbott India Limited.IndiaAntiulcerBHU-DRA/ER/B0505610-Feb-209-Feb-2023
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39BExpedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseRanitidine Hydrochloride USP eq. To Ranitidine...150mg, Excipients...q.sUMETAC-150 TabletsTablet10 Strips of 10 TabletsStripEach film coated tablet contains: Ranitidine Hydrochloride USP eq. To Ranitidine...150mg, Excipients...q.sUMEDICA LABORATORIES Pvt. Ltd. Gujarat, IndiaIndiaAntiulcerBHU-DRA/ER/B050545-Feb-204-Feb-2023
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40BExpedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman Use1 Clarithromycin USP...500mg, 2 Amoxicillin BP...500mg, 1 Rabeprazole Sodium INN...20mgPYLOCURE®Tablet and Capsule (combined)1 x 7 Blister StripBlister stripEach blister strip contains: 1 Clarithromycin USP...500mg, 2 Amoxicillin BP...500mg, 1 Rabeprazole Sodium INN...20mgOpsonin Pharma Limited, Barisal, BangladeshBangladeshMedicines for H.Pylori infectionBHU-DRA/ER/B050535-Feb-204-Feb-2023
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41BExpedited Registration Generic Drug ApplicationKuenphen Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseMetformin Hydrochloride BP...500mg, Excipients...q.sMETVIN-500 TabletsTablet1 x 10 TabletsAlu-PVC BlisterEach film coated tablet contains: Metformin Hydrochloride BP...500mg, Excipients...q.sHolden Medical Laboratories Pvt. Ltd. Nashik-422 113, IndiaIndiaAntidiabeticsBHU-DRA/ER/B050485-Feb-204-Feb-2023
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42A1Expedited Registration Generic Drug ApplicationKuenphen Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseLoperamide Hydrochloride USP...2mg, Excipients...q.sHOLDAMIDE TabletsTablet1 x 10 TabletsAlu-PVC BlisterEach tablet contains: Loperamide Hydrochloride USP...2mg, Excipients...q.sHolden Medical Laboratories Pvt. Ltd. Nashik-422 113, IndiaIndiaAntidiarrhoealBHU-DRA/ER/B050475-Feb-204-Feb-2023
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43A1Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseLiquid Paraffin I.P...1.25ml, Milk of Magnesia I.P...3.75ml, Sodium Picosulfate B.P...3.33mgCREMAFFIN® PLUS Refreshing Flavour Oral Emulsionoral emulsion200 mlPET BottleEach 5 mL (1 teaspoon approx.) contains: Liquid Paraffin I.P...1.25ml, Milk of Magnesia I.P...3.75ml, Sodium Picosulfate B.P...3.33mgAbbott India Limited.IndiaLaxativesBHU-DRA/ER/B050525-Feb-204-Feb-2023
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44A1Expedited Registration Generic Drug ApplicationKuenphen Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseIbuprofen BP...400mg, Excipients...q.sIBUDEN 400 TabletsTablet1 x 10 TabletsAlu-PVC BlisterEach film coated tablet contains: Ibuprofen BP...400mg, Excipients...q.sHolden Medical Laboratories Pvt. Ltd. Nashik-422 113, IndiaIndiaNon-steroidal anti-inflammatory medicines (NSAIMs)BHU-DRA/ER/B050495-Feb-204-Feb-2023
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45BExpedited Registration Generic Drug ApplicationKuenphen Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseCiprofloxacin Hydrochloride USP eq. To Ciprofloxacin...500mg, Excipients...q.sPROGEN-500 TabletsTablet1 x 10 TabletsAlu-PVC BlisterEach film coated tablet contains: Ciprofloxacin Hydrochloride USP eq. To Ciprofloxacin...500mg, Excipients...q.sHolden Medical Laboratories Pvt. Ltd. Nashik-422 113, IndiaIndiaAntibacterialBHU-DRA/ER/B050505-Feb-204-Feb-2023
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46BExpedited Registration Generic Drug ApplicationKuenphen Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseAtenolol BP...50mg, Excipients...q.sGENOLOL TabletsTablet1 x 10 TabletsAlu-PVC BlisterEach tablet contains: Atenolol BP...50mg, Excipients...q.sHolden Medical Laboratories Pvt. Ltd. Nashik-422 113, IndiaIndiaAntianginalBHU-DRA/ER/B050515-Feb-204-Feb-2023
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47BExpedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseSalbutamol Sulphate BP...4.81mg Eq. To Salbutamol...4.0mg, Excipients...q.sSAMOL-4 TabletTablet1000 TabletsHDPE JarEach tablet contains: Salbutamol Sulphate BP...4.81mg Eq. To Salbutamol...4.0mg, Excipients...q.sWEST-COAST PHARMACEUTICAL WORKS LTD, GUJARAT,INDIAIndiaAntiasthmatic medicines and medicines for chronic obstructive pulmonary diseaseBHU-DRA/ER/B050464-Feb-203-Feb-2023
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48BExpedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseRisperidone USP...2mg, Excipients...q.sn/aTablet100 Tablets (10 x 10)Alu-Alu BlisterEach uncoated tablet contains: Risperidone USP...2mg, Excipients...q.sDev Life Corporation, Himatnagar-383 001, Gujarat, IndiaIndiaAntipsychoticsBHU-DRA/ER/B050454-Feb-203-Feb-2023
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49BExpedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseLosartan Potassium USP...25mg, Excipients...q.sLOSA-25 TabletTablet1000 TabletsHDPE JarEach tablet contains: Losartan Potassium USP...25mg, Excipients...q.sWEST-COAST PHARMACEUTICAL WORKS LTD, GUJARAT,INDIAIndiaAntihypertensiveBHU-DRA/ER/B050424-Feb-203-Feb-2023
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50BExpedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseCiprofloxacin Hydrochloride USP...582.21mg Eq. To Ciprofloxacin...500mg, Excipients...q.sCIPFLACIN TABLETTablet100 Tablets (10 x 10)Alu-PVC BlisterEach film coated tablet contains: Ciprofloxacin Hydrochloride USP...582.21mg Eq. To Ciprofloxacin...500mg, Excipients...q.sDev Life Corporation, Himatnagar-383 001, Gujarat, IndiaIndiaAntibacterialBHU-DRA/ER/B050444-Feb-203-Feb-2023
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51BExpedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman Use1.25gm calcium carbonate BP from an organic source (oyster shell) Eq. To elemental calcium ...500mg, Vitamin D3 BP...250 IU, Excipients...q.sCALVITAN-FORTE TabletTablet1000 TabletsHDPE JarEach tablet contains: 1.25gm calcium carbonate BP from an organic source (oyster shell) Eq. To elemental calcium ...500mg, Vitamin D3 BP...250 IU, Excipients...q.sWEST-COAST PHARMACEUTICAL WORKS LTD, GUJARAT,INDIAIndiaVitamins and mineralsBHU-DRA/ER/B050434-Feb-203-Feb-2023
53
52BFull RegistrationGeneric Drug ApplicationDhejung Pharmaceuticals and Medical SuppliesHuman Allopathic MedicineHuman UseOmeprazole I.P (As enteric coated granules)...20mg, Excipients...q.sOMIDO* CapsulesCapsule10 x 10 CapsulesStripEach hard gelatin capsule contains: Omeprazole I.P (As enteric coated granules)...20mg, Excipients...q.sShine Pharmaceuticals Limited, Ta. Karjan-391 240, Gujarat, IndiaIndiaAntiulcerBHU-DRA/B050402-Feb-201-Feb-2023
54
53BFull RegistrationGeneric Drug ApplicationDhejung Pharmaceuticals and Medical SuppliesHuman Allopathic MedicineHuman UseAzithromycin I.P (As dihydrate) equivalent to Azithromycin...500mg, Excipients...q.sZOFACIN-500Tablet10 x 5 TabletsAlu-PVC BlisterEach film coated tablet contains: Azithromycin I.P (As dihydrate) equivalent to Azithromycin...500mg, Excipients...q.sShine Pharmaceuticals Limited, Ta. Karjan-391 240, Gujarat, IndiaIndiaAnthelminthicsBHU-DRA/B050412-Feb-201-Feb-2023
55
54BExpedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseSterile Water for InjectionSuperAmpInjectable50x5mLLDPE containerEach 5ml contains: Sterile Water for InjectionOtsuka Pharmaceutical India Private Limited, Ahmedabad, India
IndiaDiluentBHU-DRA/ER/B0503531-Jan-2030-Jan-2023
56
55BExpedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseDopamine Hydrochloride I.P...40mg, Water for injections I.P...q.sDOMIN InjectionInjectable5 x 5 Ampoules of 5 mlAmpouleEach ml contains: Dopamine Hydrochloride I.P...40mg, Water for injections I.P...q.sNeon Laboratories Ltd. Mumbai,IndiaIndiaVaccinesBHU-DRA/ER/B0503931-Jan-2030-Jan-2023
57
56A1Expedited Registration Generic Drug ApplicationHuman Allopathic MedicineHuman UseParacetamol.... BP 500 mg, Caffeine ...USP 65 mgATOPEN PLUS TabletTablet10 x 10 TabletsAlu-PVC BlisterEach ml contains: Paracetamol.... BP 500 mg, Caffeine ...USP 65 mgKemiko Pharmaceuticals Ltd., Bangladesh.BangladeshNon-opioid AnalgesicsBHU-DRA/ER/B0503831-Jan-2030-Jan-2023
58
57A1Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseParacetamol BP 500 mg & Caffeine BP 65 mgCAFENOL TabletTablet10 x 10 TabletsStripEach film coated tablet contains: Paracetamol BP 500 mg & Caffeine BP 65 mgGeneral Pharmaceuticals LtdBangladeshNon-opioid AnalgesicsBHU-DRA/ER/B0503131-Jan-2030-Jan-2023
59
58BExpedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseVitamin A 5000 IU Vitamin C 60 mg Vitamin D 400 IU Vitamin E 30 IU Vitamin K 25 mcg Thiamine 1.5 mg Riboflavin 1.7 mg Niacin 20 mg Pyridoxine HCL 2 mg Folic Acid 400 mcg Cyanocobalamin 6 mcg Pantothenic Acid 10 mg Biotin 30 mcg Calcium 162 mg Iron 18 mg Phosphorus 109 mg Iodine 150 mcg Magnesium 100 mg Zinc 15 mg Selenium 20 mcg Copper 2 mg Manganese 2 mg Chromium 120 mcg Molybdenum 75 mcg Chloride 72 mg Potassium 60 mg Boron 150 mcg Nickel 5 mcg Silicon 2 mg Tin 10 mcg Vanadium 10 mcg Lutein 250 mcgSuper Gold TabletTablet30 TabletsHDPE BottleEach film coated tablet contains: Vitamin A 5000 IU Vitamin C 60 mg Vitamin D 400 IU Vitamin E 30 IU Vitamin K 25 mcg Thiamine 1.5 mg Riboflavin 1.7 mg Niacin 20 mg Pyridoxine HCL 2 mg Folic Acid 400 mcg Cyanocobalamin 6 mcg Pantothenic Acid 10 mg Biotin 30 mcg Calcium 162 mg Iron 18 mg Phosphorus 109 mg Iodine 150 mcg Magnesium 100 mg Zinc 15 mg Selenium 20 mcg Copper 2 mg Manganese 2 mg Chromium 120 mcg Molybdenum 75 mcg Chloride 72 mg Potassium 60 mg Boron 150 mcg Nickel 5 mcg Silicon 2 mg Tin 10 mcg Vanadium 10 mcg Lutein 250 mcgGeneral Pharmaceuticals LtdBangladeshVitamins and mineralsBHU-DRA/ER/B0503031-Jan-2030-Jan-2023
60
59BExpedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseCarvedilol USP…12.5mg, Excipients…q.sN/ATablet1000 insertsHDPE BottleEach uncoated tablet contains: Carvedilol USP…12.5mg, Excipients…q.sHolden Medical Laboratories Pvt. Ltd. Nashik-422 113, IndiaIndiaAntihypertensiveBHU-DRA/ER/B0503431-Jan-2030-Jan-2023
61
60BExpedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseAmikacin sulphate I.P eq. to Amikacin… 250mg. In 2ml aqeous solution, Sodium citrate I.P…1.25% w/v, Sodium metabisulphate I.P…0.33% w/v, preservatives like Propyl paraben I.P…0.02% w/v and Methyl paraben I.P…0.08% w/v, Water for Injections I.P…q.sAMIKATIL-250Injectable10x2 mLVialEach vial contains: Amikacin sulphate I.P eq. to Amikacin… 250mg. In 2ml aqeous solution, Sodium citrate I.P…1.25% w/v, Sodium metabisulphate I.P…0.33% w/v, preservatives like Propyl paraben I.P…0.02% w/v and Methyl paraben I.P…0.08% w/v, Water for Injections I.P…q.sTABLETS (INDIA) LIMITED, 179, T.H. Road, Chennai - 600 081IndiaAntidiabeticsBHU-DRA/ER/B0503331-Jan-2030-Jan-2023
62
61E1Renewal RegistrationGeneric Drug ApplicationVetline Pharmaceutical and Medical SuppliesVeterinary Allopathic MedicineVeterinary UseAlbendazole IP...5% w/w, Excipients...q.sA-ZOLEpowder100 gmsHDPE ContainerComposition: Albendazole IP...5% w/w, Excipients...q.sGrampus Laboratories, Johron, Kalaamb, Sirmour (HP), IndiaIndiaAnthelminthicsBHU-DRA/RN/B0503631-Jan-2030-Jan-2023
63
62A1Expedited Registration Generic Drug ApplicationTCC Pharmaceutical & Medical Supplies, Phuentsholing, BhutanHuman Allopathic MedicineHuman UseProtein Hydrolysate 20%...1.0gm (Equivalent to total Nitrogen...30.0mg), Vitamin B1 I.P...0.5mg, Vitamin B2 I.P...0.5mg, Vitamin B6 I.P...0.5mg, Vitamin B12 I.P...0.25mcg, D-Panthenol I.P...1.0mg, Iron choline Citrate 66% soln...50mg (Equivalent to iron content 6mg), Magnesium Chloride I.P...10.0mg, Manganese Chloride U.S.P...0.1mg, Niacinamide I.P...8.0mg, Flavoured syrupy BaseVINITON™ SyrupSyrup200 mlAmber Coloured PET BottleEach 15 mL contains: Protein Hydrolysate 20%...1.0gm (Equivalent to total Nitrogen...30.0mg), Vitamin B1 I.P...0.5mg, Vitamin B2 I.P...0.5mg, Vitamin B6 I.P...0.5mg, Vitamin B12 I.P...0.25mcg, D-Panthenol I.P...1.0mg, Iron choline Citrate 66% soln...50mg (Equivalent to iron content 6mg), Magnesium Chloride I.P...10.0mg, Manganese Chloride U.S.P...0.1mg, Niacinamide I.P...8.0mg, Flavoured syrupy BaseMars Remedies Pvt. 635, G.I.D.C. Estate, Waghodia-391760, Dist.:Baroda (Gujarat)IndiaVitamins and mineralsBHU-DRA/ER/B0502130-Dec-1929-Dec-2022
64
63BExpedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseSpironolactone B.P...25mgn/aTablet1000 tabletsHDPE JarEach uncoated tablet contains: Spironolactone B.P...25mgHolden Medical Laboratories Pvt. Ltd. Nashik-422 113, IndiaIndiaDiureticsBHU-DRA/ER/B0502330-Dec-1929-Dec-2022
65
64A1Expedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseStreptococcus faecalis T-110 JPC...60 Million, Clostridium butyricum TO-A...4 Million, Bacillus mesentericus TO-A JPC...2 Million, Lactic acid bacillus(Lactobacillus Sporogenes)...100 Million,BIFILAC hp CapsuleCapsule10 x 10 CapsulesAlu-Alu BlisterEach capsule contains: Streptococcus faecalis T-110 JPC...60 Million, Clostridium butyricum TO-A...4 Million, Bacillus mesentericus TO-A JPC...2 Million, Lactic acid bacillus(Lactobacillus Sporogenes)...100 Million,TABLETS (INDIA) LIMITED, 179, T.H. Road, Chennai - 600 081IndiaAntidiabeticsBHU-DRA/ER/B0502930-Dec-1929-Dec-2022
66
65A1Expedited Registration Generic Drug ApplicationTCC Pharmaceutical & Medical Supplies, Phuentsholing, BhutanHuman Allopathic MedicineHuman UsePotassium Iodide IP 0.8%w/v, Iodine IP 0.6% w/v, Tannic acid USP 2.0% w/v, Menthol IP 0.5% w/v, Thymol IP 0.5% w/v, Camphor USP 0.5% w/v, Zinc phenol sulphonate 0.8% w/v, Mentha Oil IP 0.3% v/v, Clove Oil IP 0.3% v/v, Phenol 0.2% IP w/v, Glycerin IP...Q.SGUMEX.Oral Solution60 mlPET BottleComposition: Potassium Iodide IP 0.8%w/v, Iodine IP 0.6% w/v, Tannic acid USP 2.0% w/v, Menthol IP 0.5% w/v, Thymol IP 0.5% w/v, Camphor USP 0.5% w/v, Zinc phenol sulphonate 0.8% w/v, Mentha Oil IP 0.3% v/v, Clove Oil IP 0.3% v/v, Phenol 0.2% IP w/v, Glycerin IP...Q.SPharmadent Remedies Pvt. Ltd.IndiaAntisepticsBHU-DRA/ER/B0502030-Dec-1929-Dec-2022
67
66A1Expedited Registration Generic Drug ApplicationTCC Pharmaceutical & Medical Supplies, Phuentsholing, BhutanHuman Allopathic MedicineHuman UsePotassium Iodide IP 0.8%w/v, Iodine IP 0.6% w/v, Tannic acid USP 2.0% w/v, Menthol IP 0.5% w/v, Thymol IP 0.5% w/v, Camphor USP 0.5% w/v, Zinc phenol sulphonate 0.8% w/v, Mentha Oil IP 0.3% v/v, Clove Oil IP 0.3% v/v, Phenol 0.2% IP w/v, Glycerin IP...Q.SGUMEX.Oral Solution25 mlPET BottleComposition: Potassium Iodide IP 0.8%w/v, Iodine IP 0.6% w/v, Tannic acid USP 2.0% w/v, Menthol IP 0.5% w/v, Thymol IP 0.5% w/v, Camphor USP 0.5% w/v, Zinc phenol sulphonate 0.8% w/v, Mentha Oil IP 0.3% v/v, Clove Oil IP 0.3% v/v, Phenol 0.2% IP w/v, Glycerin IP...Q.SPharmadent Remedies Pvt. Ltd.IndiaAntisepticsBHU-DRA/ER/B0501930-Dec-1929-Dec-2022
68
67A1Expedited Registration Generic Drug ApplicationTCC Pharmaceutical & Medical Supplies, Phuentsholing, BhutanHuman Allopathic MedicineHuman UsePotassium Iodide IP 0.8%w/v, Iodine IP 0.6% w/v, Tannic acid USP 2.0% w/v, Menthol IP 0.5% w/v, Thymol IP 0.5% w/v, Camphor USP 0.5% w/v, Zinc phenol sulphonate 0.8% w/v, Mentha Oil IP 0.3% v/v, Clove Oil IP 0.3% v/v, Phenol 0.2% IP w/v, Glycerine IP ..Q.SGUMEX.Oral Solution10 mlPET BottleComposition: Potassium Iodide IP 0.8%w/v, Iodine IP 0.6% w/v, Tannic acid USP 2.0% w/v, Menthol IP 0.5% w/v, Thymol IP 0.5% w/v, Camphor USP 0.5% w/v, Zinc phenol sulphonate 0.8% w/v, Mentha Oil IP 0.3% v/v, Clove Oil IP 0.3% v/v, Phenol 0.2% IP w/v, Glycerine IP ..Q.SPharmadent Remedies Pvt. Ltd.IndiaAntisepticsBHU-DRA/ER/B0501830-Dec-1929-Dec-2022
69
68A1Expedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseLactulose Concentrate U.S.P equivalent to Lactulose...10g, Aqeous flavored base...q.sCadilose SolutionSolution100 mlAmber Coloured PET BottleEach 15mL contains: Lactulose Concentrate U.S.P equivalent to Lactulose...10g, Aqeous flavored base...q.sCADILA PHARMACEUTICALS LIMITED, Ahmedabad, India.IndiaLaxativesBHU-DRA/ER/B0502630-Dec-1929-Dec-2022
70
69BExpedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseFluoxetineHydrochloride I.P equivalent to Fluoxetine...20mgFludac 20 mg CapsuleCapsule10 x 2 x 15 CapsulesAlu-PVC BlisterEach hard gelatin capsule contains: FluoxetineHydrochloride I.P equivalent to Fluoxetine...20mgCADILA PHARMACEUTICALS LIMITED, Ahmedabad, India.IndiaAntidepressantBHU-DRA/ER/B0502730-Dec-1929-Dec-2022
71
70BExpedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseCarbamazepine U.S.P...200mgn/aTablet1000 tabletsHDPE JarEach tablet contains: Carbamazepine U.S.P...200mgHolden Medical Laboratories Pvt. Ltd. Nashik-422 113, IndiaIndiaAnticonvulsant/ AntiepilepticsBHU-DRA/ER/B0502430-Dec-1929-Dec-2022
72
71BExpedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseAtorvastatin Calcium I.P equivalent to AtorvastatinATORBEST 10 TabletTablet5 x 3 x 10 TabletsAlu-Alu BlisterEach film coated tablet contains: Atorvastatin Calcium I.P equivalent to AtorvastatinCADILA PHARMACEUTICALS LIMITED, Ahmedabad, India.IndiaLipid-lowering agentsBHU-DRA/ER/B0502830-Dec-1929-Dec-2022
73
72BExpedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseAmlodipine Besylate equivalent to
Amlodipine U.S.P...5 mg
n/aTablet1000 tabletsHDPE JarEach tablet contains: Amlodipine Besylate equivalent to
Amlodipine U.S.P...5 mg
Holden Medical Laboratories Pvt. Ltd. Nashik-422 113, IndiaIndiaAntihypertensiveBHU-DRA/ER/B0502530-Dec-1929-Dec-2022
74
73BExpedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseAmitriptyline Hydrochloride B.P...25mgn/aTablet1000 tabletsHDPE JarEach film coated tablet contains: Amitriptyline Hydrochloride B.P...25mgHolden Medical Laboratories Pvt. Ltd. Nashik-422 113, IndiaIndiaAntidepressantBHU-DRA/ER/B0502230-Dec-1929-Dec-2022
75
74BExpedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UsePhenoxymethylpenicillin Potassium BP...277.2mg equivalent to Phenoxymethylpenicillin...250mgOPEN 250 TabletTablet10 x 10 TabletsStripEach tablet contains: Phenoxymethylpenicillin Potassium BP...277.2mg equivalent to Phenoxymethylpenicillin...250mgOpsonin Pharma Limited, Barisal, BangladeshBangladeshAntibacterialBHU-DRA/ER/B0501716-Dec-1915-Dec-2022
76
75BExpedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman Usezinc sulfate monohydrate USP equivalent to elemental zinc...20mgXinc 20 TabletTablet60 TabletsAlu-PVDC BlisterEach tablet contains: zinc sulfate monohydrate USP equivalent to elemental zinc...20mgESKAYEF BANGLADESH LIMITEDBangladeshVitamins and mineralsBHU-DRA/ER/B0501510-Dec-199-Dec-2022
77
76BExpedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseNitrofurantoin BP...100mg, Excipients...q.sNYTODEV TabletsTablet10 x 10Alu-PVC BlisterEach uncoated tablet contains: Nitrofurantoin BP...100mg, Excipients...q.sDev Life Corporation, Himatnagar-383 001, Gujarat, IndiaIndiaAntibacterialBHU-DRA/ER/B0501610-Dec-199-Dec-2022
78
77BExpedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UsePrednisolone BP...20mgPRED 20 TabletTablet50 TabletsAlu-PVDC BlisterEach tablet contains: Prednisolone BP...20mgESKAYEF BANGLADESH LIMITEDBangladeshSteroidal Anti-inflammatoryBHU-DRA/ER/B050146-Dec-195-Dec-2022
79
78E2Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesVeterinary Allopathic MedicineVeterinary UseFlunixin Meglumine USP equivalent to Flunixin...50mgPif R vet InjectionInjectable10 mlVialEach ml contains: Flunixin Meglumine USP equivalent to Flunixin...50mgESKAYEF BANGLADESH LIMITEDBangladeshNon-steroidal anti-inflammatory medicines (NSAIMs)BHU-DRA/ER/B050136-Dec-195-Dec-2022
80
79BFull RegistrationGeneric Drug ApplicationKuenphen Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseD-Panthenol I.P...5.0%w/v, Sodium Hyaluronate B.P Eq. To Hyaluronic Acid...0.1% w/v, Stabilized Oxychloro Complex...0.01% w/v (As Preservative), Sterile Aqeous Vehicle...Q.SOPTIVIEW -HA Eye DropsDrops10 mlLupolene BottleComposition: D-Panthenol I.P...5.0%w/v, Sodium Hyaluronate B.P Eq. To Hyaluronic Acid...0.1% w/v, Stabilized Oxychloro Complex...0.01% w/v (As Preservative), Sterile Aqeous Vehicle...Q.SSuyaash Pharmaceuticals, 216/5-6, Village Khundh, Taluka-Chikhli, Dist-Navsari-396521, Gujarat.IndiaOpthalmic lubricantBHU-DRA/B050134-Dec-193-Dec-2022
81
80A1Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseSilymarin...70mg, Thiamine monohydrate IP...5mg, Riboflavin IP...5mg, Pyridoxine Hydrochloride IP...1.5mg, Niacinamide IP...25mg, Calcium Pantothenate IP...7.5mg, Vitamin B12 IP...5mcg, Excipients...q.sLIVOSIL-B CapsuleCapsule10 Blisters of 10 Capsules eachBlister Each capsule contains: Silymarin...70mg, Thiamine monohydrate IP...5mg, Riboflavin IP...5mg, Pyridoxine Hydrochloride IP...1.5mg, Niacinamide IP...25mg, Calcium Pantothenate IP...7.5mg, Vitamin B12 IP...5mcg, Excipients...q.sCentaur Pharmaceuticals Pvt. Ltd., Santacruz(E0,Mumbai 400 055 IndiaIndiaVitamins and mineralsBHU-DRA/ER/B050073-Dec-192-Dec-2022
82
81BExpedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseLosartan Potassium IP...50mg,Losatrust 50 TabletsTablet10 x 10 TabletsBlister Each film coated tablet contains: Losartan Potassium IP...50mg,Centaur Pharmaceuticals Pvt. Ltd., Santacruz(E0,Mumbai 400 055 IndiaIndiaAntihypertensiveBHU-DRA/ER/B050063-Dec-192-Dec-2022
83
82BExpedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseKetaconazole IP...2% w/v, Lotion Base...q.s, Preservative: Imidazolidinyl Urea...0.3%w/vKz Lotionlotion50 mlCollapsible Lami TubeComposition: Ketaconazole IP...2% w/v, Lotion Base...q.s, Preservative: Imidazolidinyl Urea...0.3%w/vHeSa Pharmaceutica, Batoli Kalan, Baddi, Dist.: 173 205 (H.P.)IndiaAntifungalBHU-DRA/ER/B050083-Dec-192-Dec-2022
84
83BExpedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseGriseofulvin BP...250mg, Excipients...q.sDEVOGRI TabletsTablet10 x 10 TabletsBlister Each uncoated tablet contains: Griseofulvin BP...250mg, Excipients...q.sDev Life Corporation, Himatnagar-383 001, Gujarat, IndiaIndiaAntifungalBHU-DRA/ER/B050053-Dec-192-Dec-2022
85
84A2Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseAloe vera Gel...10% w/w, Light Liquid Paraffin...10%w/w, Calamine...8%w/w, In a moisturising lotion base containing Dimethicone and Olivem-800n/alotion100 mlLami Collapsible tubeComposition: Aloe vera Gel...10% w/w, Light Liquid Paraffin...10%w/w, Calamine...8%w/w, In a moisturising lotion base containing Dimethicone and Olivem-800HeSa Pharmaceutica, Batoli Kalan, Baddi, Dist.: 173 205 (H.P.)IndiaAnti-inflammatory and antipruriticBHU-DRA/ER/B050103-Dec-192-Dec-2022
86
85A2Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseAloe Vera Gel...10% w/w, Light liquid paraffin...10% w/w, Calamine...8% w/w, In a moisturising lotion base containing Dimethicone and Olivem-800n/alotion60 mlLami Collapsible tubeComposition: Aloe Vera Gel...10% w/w, Light liquid paraffin...10% w/w, Calamine...8% w/w, In a moisturising lotion base containing Dimethicone and Olivem-800HeSa Pharmaceutica, Batoli Kalan, Baddi, Dist.: 173 205 (H.P.)IndiaAnti-inflammatory and antipruriticBHU-DRA/ER/B050093-Dec-192-Dec-2022
87
86A1Full RegistrationGeneric Drug ApplicationKuenphen Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseSodium Carboxymethyl cellulose IP...0.5%w/v, Stabilized Oxychloro complex...0.005% w/v (As preservative), Purified water IP...Q.SOPTIVIEW Lubricant Eye DropsDrops10 mlLupolene BottleComposition: Sodium Carboxymethyl cellulose IP...0.5%w/v, Stabilized Oxychloro complex...0.005% w/v (As preservative), Purified water IP...Q.SSuyaash Pharmaceuticals, 216/5-6, Village Khundh, Taluka-Chikhli, Dist-Navsari-396521, Gujarat.IndiaOpthalmic lubricantBHU-DRA/B050123-Dec-192-Dec-2022
88
87BExpedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseNorfloxacin BP...400mg, Excipients...q.sNORDEV TabletsTablet10 x 10 TabletsAlu-PVC BlisterEach film coated tablet contains: Norfloxacin BP...400mg, Excipients...q.sDev Life Corporation, Himatnagar-383 001, Gujarat, IndiaIndiaAntibacterialBHU-DRA/ER/B0500427-Nov-1926-Nov-2022
89
88BExpedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseTolfenamic Acid BP...200mgTufnil TabletTablet50 TabletsAlu-PVC BlisterEach tablet contains: Tolfenamic Acid BP...200mgESKAYEF BANGLADESH LIMITEDBangladeshNon-steroidal anti-inflammatory medicines (NSAIMs)BHU-DRA/ER/B0500326-Nov-1925-Nov-2022
90
89BExpedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseClopidogrel Bisulfate USP eq. To Clopidogrel...75 mg, Excipients...q.sDEVIGREL 75 TabletsTablet10 x 10 TabletsAlu-PVC BlisterEach film coated tablet contains: Clopidogrel Bisulfate USP eq. To Clopidogrel...75 mg, Excipients...q.sDev Life Corporation, Himatnagar-383 001, Gujarat, IndiaIndiaAntithromboticBHU-DRA/ER/B0500226-Nov-1925-Nov-2022
91
90BExpedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseItopride Hydrochloride...50mg, Excipients...q.sGanaton® TabletTablet10 x 10 TabletsBlister Each film coated tablet contains: Itopride Hydrochloride...50mg, Excipients...q.sAbbott India Limited.IndiaProkineticBHU-DRA/ER/B0500121-Nov-1920-Nov-2022
92
91A1Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseIbuprofen I.P...400mgBRUFEN 400Tablet15x4x15 TabletsBlister Each film coated tablet contains: Ibuprofen I.P...400mgAbbott India Limited.IndiaNon-steroidal anti-inflammatory medicines (NSAIMs)BHU-DRA/ER/B0500021-Nov-1920-Nov-2022
93
92FAbridged RegistrationGeneric Drug ApplicationDepartment of Public Health, Ministry of Health, BhutanHuman Allopathic MedicineHuman UseActive ingredient: Purified inactivated influenza Virus Antigen (In-House) A strain (2019-20 NH Formula) A Brisbance/02/2018 Reassortant virus IVR-190(H1N1)...15microgram, [A/Kansas/14/2017 Reassortant virus NYMC X-327 (H3N2)...15microgram, B Strain (2019-20 NH Formula) [B/Maryland/15/2016 Reassortant virus NYMC BX-69(BV)...15 microgram, Buffer sodium chloride(USP)...4.25mg, Di-Sodium hydrogen phosphate dodecahydrate (EP)...1.40mg, Potassium dihydrogen phosphate (EP)...0.15 mg, Solvent: Water for injection (KP)...q.sIL-Yang Flu Vaccine Prefilled Syringe InjectionInjectable0.5 mlVial1 vial (0.5mL) contains: Active ingredient: Purified inactivated influenza Virus Antigen (In-House) A strain (2019-20 NH Formula) A Brisbance/02/2018 Reassortant virus IVR-190(H1N1)...15microgram, [A/Kansas/14/2017 Reassortant virus NYMC X-327 (H3N2)...15microgram, B Strain (2019-20 NH Formula) [B/Maryland/15/2016 Reassortant virus NYMC BX-69(BV)...15 microgram, Buffer sodium chloride(USP)...4.25mg, Di-Sodium hydrogen phosphate dodecahydrate (EP)...1.40mg, Potassium dihydrogen phosphate (EP)...0.15 mg, Solvent: Water for injection (KP)...q.sIL-Yang Pharma. Co., Ltd.,KoreaVaccinesBHU-DRA/AR/B0498220-Nov-1919-Nov-2022
94
93A1Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseOxymetazoline Hydrochloride USP...0.5mgSinarest Nasal DropsDrops10 mlLupolene VialEach ml contains: Oxymetazoline Hydrochloride USP...0.5mgCentaur Pharmaceuticals Pvt. Ltd., Santacruz(E0,Mumbai 400 055 IndiaIndiaNasal DecongestantBHU-DRA/ER/B0499720-Nov-1919-Nov-2022
95
94BFull RegistrationGeneric Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseOndansetron Hydrochloride USP equivalent to Ondansetron...4mg, Sodium Chloride USP...18mg, Citric Acid Monohydrate USP...1mg, Sodium Citrate USP...0.5mg, Water for Injection USP...q.sONSTAR 4 InjectionInjectable10 Ampoules of 2 ml eachAmpouleEach sterile ampoule contains: Ondansetron Hydrochloride USP equivalent to Ondansetron...4mg, Sodium Chloride USP...18mg, Citric Acid Monohydrate USP...1mg, Sodium Citrate USP...0.5mg, Water for Injection USP...q.sCelon Laboratories Pvt. Ltd., Plot No: 2, ALEAP Industrial Estate, Telangana state, India.IndiaAntiemeticBHU-DRA/B0499920-Nov-1919-Nov-2022
96
95BAbridged RegistrationGeneric Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseSoyabean Oil USP...10.00g, Egg Lecithen...1.20g, Glycerol USP...2.25g, Water for injections BP...q.s, Energy Content...1100 kcal/L, Osmolarity...300 mOsmol/LCELEPID 10% Intravenous Fat EmulsionInjectable500 mlGlass BottleEach 100ml (of emulsion) contains: Soyabean Oil USP...10.00g, Egg Lecithen...1.20g, Glycerol USP...2.25g, Water for injections BP...q.s, Energy Content...1100 kcal/L, Osmolarity...300 mOsmol/LOtsuka Pharmaceutical India Private Limited, Ahmedabad, India
IndiaLipid emulsion for parenteral nutritionBHU-DRA/AR/B0498320-Nov-1919-Nov-2022
97
96BExpedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UsePolymyxin-B Sulphate BP...10000 Units, Chloramphenicol IP...10mg, Sterile base...q.sOCUPOL Eye OintmentOintment5 gCollapsible tubeEach gm contains: Polymyxin-B Sulphate BP...10000 Units, Chloramphenicol IP...10mg, Sterile base...q.sCentaur Pharmaceuticals Pvt. Ltd., Santacruz(E0,Mumbai 400 055 IndiaIndiaAntibacterialBHU-DRA/ER/B0498620-Nov-1919-Nov-2022
98
97A1Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseBromhexine Hydrochloride BP...4 mgMucoten SyrupSyrup100 mlPET BottleEach 5 ml of syrup contains: Bromhexine Hydrochloride BP...4 mgESKAYEF BANGLADESH LIMITEDBangladeshMucoactive agentBHU-DRA/ER/B0499820-Nov-1919-Nov-2022
99
98BExpedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseWarfarin Sodium BP...1mg, Excipients...q.sREFARIN TMTablet10 x 10Alu-PVC BlisterEach uncoated tablet contains: Warfarin Sodium BP...1mg, Excipients...q.sDev Life Corporation, Himatnagar-383 001, Gujarat, IndiaIndiaAntithromboticBHU-DRA/ER/B0499312-Nov-1911-Nov-2022
100
99C1Expedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic MedicineHuman UseTramadol Hydrochloride I.P...50mg, Water for injections I.P...q.sSUPRIDOL InjectionInjectable10 x 5 Amps. Of 1 mlAmpouleEach ml contains: Tramadol Hydrochloride I.P...50mg, Water for injections I.P...q.sNeon Laboratories Ltd. Mumbai,IndiaIndiaOpioid analgesicsBHU-DRA/ER/B0498312-Nov-1911-Nov-2022