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235Registration Type*Application Type*Market Authorization HolderCategory Of Medical Product*This product is intended for *Generic Name*Brand NameDosage Form*Pack Size*Type of Packaging*Composition of active ingredients with strength*Manufacturer *Country of the manufacturer*Therapeutic CategoryCertificate NumberIssued DateExpiry Date
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1Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseProchlorperazine Maleate I.P...5mgStemetil® MD TabletTablet25 x 2 x 10 TabletsStripEach uncoated mouth dissolving tablet contains: Prochlorperazine Maleate I.P...5mgAbbott India Limited.IndiaAntipsychoticBHU-DRA/ER/B0509217-Mar-2017-Mar-2023
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2Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseLoratadine USP...5mgORADIN SuspensionSuspension60 mlAmber Glass BottleEach 5 ml contains: Loratadine USP...5mgESKAYEF BANGLADESH LIMITEDBangladeshAnti-HistamineBHU-DRA/ER/B0509017-Mar-2017-Mar-2023
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3Full RegistrationGeneric Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.BangladeshAnti-HistamineBHU-DRA/B0509117-Mar-2017-Mar-2023
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4Expedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseCetirizine Dihydrochloride BP...10mgCetrigen TabletTablet1000 TabletsHDPE ContainerEach film coated tablet contains: Cetirizine Dihydrochloride BP...10mgHolden Medical Laboratories Pvt. Ltd. Nashik-422 113, IndiaIndiaAnti-HistamineBHU-DRA/ER/B0508917-Mar-2017-Mar-2023
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5Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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. LtdIndiaVitaminsBHU-DRA/ER/B0508811-Mar-2011-Mar-2023
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6Expedited Registration Generic Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaUrologicalsBHU-DRA/ER/B0508611-Mar-2011-Mar-2023
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7Full RegistrationGeneric Drug ApplicationParuna Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseParacetamol IP…500mg, Excipients…q.sPOLYMOL TabletsTablet20x15 TabletsAlu-PVC BlisterEach uncoated tablet contains: Paracetamol IP…500mg, Excipients…q.sSCOTT-EDIL PHARMACIA, Himachal Pradesh, India.IndiaAnalgesic and AntipyreticBHU-DRA/B0508511-Mar-2011-Mar-2023
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8Full RegistrationGeneric Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseOmeprazole Sodium BP Eq. to Omeprazole…40mgAUDURAS InjectionPowder for Injection1 VialVialEach vial contains: Omeprazole Sodium BP Eq. to Omeprazole…40mgAccelius Global, Gujarat, India.IndiaAnti-ulcerBHU-DRA/B0508411-Mar-2011-Mar-2023
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9Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.IndiaMineral and vitaminsBHU-DRA/ER/B0508711-Mar-2011-Mar-2023
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10Full RegistrationGeneric Drug ApplicationVetline Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseFluconazole IP…150mg, Excipients…q.sFLEZIS-150Tablet20x1x1Alu-PVC BlisterEach uncoated tablet contains: Fluconazole IP…150mg, Excipients…q.sGrampus Laboratories, Johron, Kalaamb, Sirmour (HP), IndiaIndiaAnti-FungalBHU-DRA/B0508311-Mar-2011-Mar-2023
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11Full RegistrationGeneric Drug ApplicationParuna Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.IndiaAntibioticBHU-DRA/B0507810-Mar-2010-Mar-2023
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12Expedited Registration Generic Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAnti-HistamineBHU-DRA/ER/B0506810-Mar-2010-Mar-2023
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13Full RegistrationGeneric Drug ApplicationParuna Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.IndiaAntiseptic and DisinfectantBHU-DRA/B0507710-Mar-2010-Mar-2023
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14Expedited Registration Generic Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAntiseizureBHU-DRA/ER/B0507610-Mar-2010-Mar-2023
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15Expedited Registration Generic Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaProkinetic agentBHU-DRA/ER/B0506910-Mar-2010-Mar-2023
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16Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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 LIMITEDBangladeshMineral and vitaminsBHU-DRA/ER/B0507410-Mar-2010-Mar-2023
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17Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, SIKKIMIndiaMineral and vitaminsBHU-DRA/ER/B0507510-Mar-2010-Mar-2023
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18Expedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseGlycerin I.P...85% w/wn/aSuppository4g x 50 SuppositoriesHDPE JarComposition: Glycerin I.P...85% w/wArora Pharmaceuticals Pvt. Ltd.IndiaLaxativeBHU-DRA/ER/B0506710-Mar-2010-Mar-2023
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19Full RegistrationGeneric Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.IndiaHaemo-dialysis liquidBHU-DRA/B0508110-Mar-2010-Mar-2023
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20Full RegistrationGeneric Drug ApplicationParuna Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseCetirizine Hydrochloride I.P...10mg, Excipients...q.sARTIZEN TabletsTablet10 x 10 TabletsAlu-PVC BlisterEach film coated tablet contains: Cetirizine Hydrochloride I.P...10mg, Excipients...q.sSCOTT-EDIL PHARMACIA, Himachal Pradesh, India.IndiaAnti-HistamineBHU-DRA/B0507910-Mar-2010-Mar-2023
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21Full RegistrationGeneric Drug ApplicationParuna Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.IndiaAntibioticBHU-DRA/B0508210-Mar-2010-Mar-2023
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22Expedited Registration Generic Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseCalcium lactate I.P...300mgORBILACTATE 300 TabletTablet100 TabletsHDPE JarEach uncoated tablet contains: Calcium lactate I.P...300mgORBIT PHARMACEUTICALS., Ahmedabad, IndiaIndiaVitaminsBHU-DRA/ER/B0507110-Mar-2010-Mar-2023
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23Expedited Registration Generic Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAnti-HaemorrhoidalBHU-DRA/ER/B0507010-Mar-2010-Mar-2023
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24Full RegistrationGeneric Drug ApplicationParuna Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.IndiaAnti-GoutBHU-DRA/B0508010-Mar-2010-Mar-2023
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25Expedited Registration Generic Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseAcyclovir I.P...400 mgOROVIR 400 TabletTablet100 TabletsHDPE JarEach uncoated tablet contains: Acyclovir I.P...400 mgORBIT PHARMACEUTICALS., Ahmedabad, IndiaIndiaAnti-ViralBHU-DRA/ER/B0507210-Mar-2010-Mar-2023
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26Expedited Registration Generic Drug ApplicationLamgong Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAnti-ViralBHU-DRA/ER/B0507310-Mar-2010-Mar-2023
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27Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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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28Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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 IndiaIndiaAnti-hypertensiveBHU-DRA/ER/B0505925-Feb-2024-Feb-2023
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29Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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 IndiaIndiaAnti-hypertensiveBHU-DRA/ER/B0505825-Feb-2024-Feb-2023
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30Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseFluconazole BP...150mgFLUCONAZOLE 150 mg TabletsTablet3 x 4 TabletsAlu-Alu BlisterEach tablet contains: Fluconazole BP...150mgThe ACME Laboratories Ltd., Dhaka, Bangladesh.BangladeshAnti-FungalBHU-DRA/ER/B0506325-Feb-2024-Feb-2023
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31Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseMiconized fenofibrate BP...200mgLIPIDOF 200 CapsuleCapsule2 x 10 CapsulesAlu-PVC BlisterEach capsule contains: Miconized fenofibrate BP...200mgThe ACME Laboratories Ltd., Dhaka, Bangladesh.BangladeshfibrateBHU-DRA/ER/B0506425-Feb-2024-Feb-2023
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32Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseAspirin BP...75mgECOSPRIN 75 TabletsTablet10 x 10 TabletsStripEach enteric coated tablet contains: Aspirin BP...75mgThe ACME Laboratories Ltd., Dhaka, Bangladesh.BangladeshAnalgesic, antiinflammatory, antipyretic and antiplateletBHU-DRA/ER/B0506225-Feb-2024-Feb-2023
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33Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.IndiaAntacidBHU-DRA/ER/B0506125-Feb-2024-Feb-2023
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34Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.IndiaAntacidBHU-DRA/ER/B0506625-Feb-2024-Feb-2023
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35Expedited Registration Generic Drug ApplicationKuenphen Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.,IndiaAntibioticBHU-DRA/ER/B0505725-Feb-2024-Feb-2023
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36Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseAcetazolamide BP...250mgACEMOX TabletsTablet10 x 10 TabletsStripEach tablet contains: Acetazolamide BP...250mgThe ACME Laboratories Ltd., Dhaka, Bangladesh.BangladeshCarbonic Anhydrase inhibitorBHU-DRA/ER/B0506525-Feb-2024-Feb-2023
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37Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.IndiaAntacidBHU-DRA/ER/B0505510-Feb-209-Feb-2023
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38Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.IndiaAntacidBHU-DRA/ER/B0505610-Feb-209-Feb-2023
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39Expedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAnti-ulcerBHU-DRA/ER/B050545-Feb-204-Feb-2023
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40Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, BangladeshBangladeshEradication of H.PyloriBHU-DRA/ER/B050535-Feb-204-Feb-2023
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41Expedited Registration Generic Drug ApplicationKuenphen Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAnti-DiabeticBHU-DRA/ER/B050485-Feb-204-Feb-2023
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42Expedited Registration Generic Drug ApplicationKuenphen Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAnti-Diarrhoeal AgentBHU-DRA/ER/B050475-Feb-204-Feb-2023
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43Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.IndiaLaxativeBHU-DRA/ER/B050525-Feb-204-Feb-2023
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44Expedited Registration Generic Drug ApplicationKuenphen Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAnalgesicBHU-DRA/ER/B050495-Feb-204-Feb-2023
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45Expedited Registration Generic Drug ApplicationKuenphen Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAntibioticBHU-DRA/ER/B050505-Feb-204-Feb-2023
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46Expedited Registration Generic Drug ApplicationKuenphen Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAnti-hypertensiveBHU-DRA/ER/B050515-Feb-204-Feb-2023
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47Expedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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,INDIAIndiaBronchodilators and Anti-asthmaBHU-DRA/ER/B050464-Feb-203-Feb-2023
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48Expedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAntipsychoticBHU-DRA/ER/B050454-Feb-203-Feb-2023
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49Expedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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,INDIAIndiaAnti-hypertensiveBHU-DRA/ER/B050424-Feb-203-Feb-2023
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50Expedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAntibioticBHU-DRA/ER/B050444-Feb-203-Feb-2023
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51Expedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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,INDIAIndiaMineral and vitaminsBHU-DRA/ER/B050434-Feb-203-Feb-2023
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52Full RegistrationGeneric Drug ApplicationDhejung Pharmaceuticals and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAnti-ulcerBHU-DRA/B050402-Feb-201-Feb-2023
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53Full RegistrationGeneric Drug ApplicationDhejung Pharmaceuticals and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAnti-HelminticBHU-DRA/B050412-Feb-201-Feb-2023
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54Expedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseSterile Water for InjectionSuperAmpInjectable50x5mLLDPE containerEach 5ml contains: Sterile Water for InjectionOtsuka Pharmaceutical India Private Limited, Ahmedabad, India
IndiaSolvents and diluting agentsBHU-DRA/ER/B0503531-Jan-2030-Jan-2023
56
55Expedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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,IndiaIndiaAdrenergic and Dopaminergic agentBHU-DRA/ER/B0503931-Jan-2030-Jan-2023
57
56Expedited Registration Generic Drug ApplicationHuman Allopathic Medicine Human 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.BangladeshAntipyretic and AnalgesicBHU-DRA/ER/B0503831-Jan-2030-Jan-2023
58
57Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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 LtdBangladeshAnalgesicBHU-DRA/ER/B0503131-Jan-2030-Jan-2023
59
58Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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 TabletsHPPE 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 LtdBangladeshMineral and vitaminsBHU-DRA/ER/B0503031-Jan-2030-Jan-2023
60
59Expedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseCarvedilol USP…12.5mg, Excipients…q.sN/ATablet1x28 TabletsHPPE BottleEach uncoated tablet contains: Carvedilol USP…12.5mg, Excipients…q.sHolden Medical Laboratories Pvt. Ltd. Nashik-422 113, IndiaIndiaAnti-hypertensiveBHU-DRA/ER/B0503431-Jan-2030-Jan-2023
61
60Expedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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 081IndiaAntibioticBHU-DRA/ER/B0503331-Jan-2030-Jan-2023
62
61Renewal 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), IndiaIndiaAnti HelminticBHU-DRA/RN/B0503631-Jan-2030-Jan-2023
63
62Expedited Registration Generic Drug ApplicationTCC Pharmaceutical & Medical Supplies, Phuentsholing, BhutanHuman Allopathic Medicine Human 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)IndiaMineral and vitaminsBHU-DRA/ER/B0502130-Dec-1929-Dec-2022
64
63Expedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseSpironolactone B.P...25mgn/aTablet1000 tabletsHDPE JarEach uncoated tablet contains: Spironolactone B.P...25mgHolden Medical Laboratories Pvt. Ltd. Nashik-422 113, IndiaIndiaDiureticBHU-DRA/ER/B0502330-Dec-1929-Dec-2022
65
64Expedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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 081IndiaPre and ProbioticBHU-DRA/ER/B0502930-Dec-1929-Dec-2022
66
65Expedited Registration Generic Drug ApplicationTCC Pharmaceutical & Medical Supplies, Phuentsholing, BhutanHuman Allopathic Medicine Human 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.IndiaAntiseptic, astringent, analgesicBHU-DRA/ER/B0502030-Dec-1929-Dec-2022
67
66Expedited Registration Generic Drug ApplicationTCC Pharmaceutical & Medical Supplies, Phuentsholing, BhutanHuman Allopathic Medicine Human 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.IndiaAntiseptic, astringent, analgesicBHU-DRA/ER/B0501930-Dec-1929-Dec-2022
68
67Expedited Registration Generic Drug ApplicationTCC Pharmaceutical & Medical Supplies, Phuentsholing, BhutanHuman Allopathic Medicine Human 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.IndiaAntiseptic, astringent, analgesicBHU-DRA/ER/B0501830-Dec-1929-Dec-2022
69
68Expedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.IndiaLaxativeBHU-DRA/ER/B0502630-Dec-1929-Dec-2022
70
69Expedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.IndiaAnti-depressantBHU-DRA/ER/B0502730-Dec-1929-Dec-2022
71
70Expedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseCarbamazepine U.S.P...200mgn/aTablet1000 tabletsHDPE JarEach tablet contains: Carbamazepine U.S.P...200mgHolden Medical Laboratories Pvt. Ltd. Nashik-422 113, IndiaIndiaAnti-convulsantBHU-DRA/ER/B0502430-Dec-1929-Dec-2022
72
71Expedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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 agentBHU-DRA/ER/B0502830-Dec-1929-Dec-2022
73
72Expedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaCalcium Channel BlockerBHU-DRA/ER/B0502530-Dec-1929-Dec-2022
74
73Expedited Registration Generic Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseAmitriptyline Hydrochloride B.P...25mgn/aTablet1000 tabletsHDPE JarEach film coated tablet contains: Amitriptyline Hydrochloride B.P...25mgHolden Medical Laboratories Pvt. Ltd. Nashik-422 113, IndiaIndiaAnti-depressantBHU-DRA/ER/B0502230-Dec-1929-Dec-2022
75
74Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, BangladeshBangladeshAntibioticBHU-DRA/ER/B0501716-Dec-1915-Dec-2022
76
75Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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 LIMITEDBangladeshMineralsBHU-DRA/ER/B0501510-Dec-199-Dec-2022
77
76Expedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAntibioticBHU-DRA/ER/B0501610-Dec-199-Dec-2022
78
77Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UsePrednisolone BP...20mgPRED 20 TabletTablet50 TabletsAlu-PVDC BlisterEach tablet contains: Prednisolone BP...20mgESKAYEF BANGLADESH LIMITEDBangladeshanti-inflammatory, immunosuppressiveBHU-DRA/ER/B050146-Dec-195-Dec-2022
79
78Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseFlunixin Meglumine USP equivalent to Flunixin...50mgPif R vet InjectionInjectable10 mlVialEach ml contains: Flunixin Meglumine USP equivalent to Flunixin...50mgESKAYEF BANGLADESH LIMITEDBangladeshAnalgesic, Anti-inflammatory and Anti-pyreticBHU-DRA/ER/B050136-Dec-195-Dec-2022
80
79Full RegistrationGeneric Drug ApplicationKuenphen Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.IndiaEye LubricantBHU-DRA/B050134-Dec-193-Dec-2022
81
80Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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 IndiaIndiaAcute and Chronic HepatitisBHU-DRA/ER/B050073-Dec-192-Dec-2022
82
81Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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 IndiaIndiaAnti-hypertensiveBHU-DRA/ER/B050063-Dec-192-Dec-2022
83
82Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.)IndiaAnti-FungalBHU-DRA/ER/B050083-Dec-192-Dec-2022
84
83Expedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAnti-FungalBHU-DRA/ER/B050053-Dec-192-Dec-2022
85
84Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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-pruriticBHU-DRA/ER/B050103-Dec-192-Dec-2022
86
85Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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-pruriticBHU-DRA/ER/B050093-Dec-192-Dec-2022
87
86Full RegistrationGeneric Drug ApplicationKuenphen Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.IndiaEye LubricantBHU-DRA/B050123-Dec-192-Dec-2022
88
87Expedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAntibioticBHU-DRA/ER/B0500427-Nov-1926-Nov-2022
89
88Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseTolfenamic Acid BP...200mgTufnil TabletTablet50 TabletsAlu-PVC BlisterEach tablet contains: Tolfenamic Acid BP...200mgESKAYEF BANGLADESH LIMITEDBangladeshTreatment of Acute MigraineBHU-DRA/ER/B0500326-Nov-1925-Nov-2022
90
89Expedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaAnti-plateletBHU-DRA/ER/B0500226-Nov-1925-Nov-2022
91
90Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseItopride Hydrochloride...50mg, Excipients...q.sGanaton® TabletTablet10 x 10 TabletsBlister Each film coated tablet contains: Itopride Hydrochloride...50mg, Excipients...q.sAbbott India Limited.IndiaProkinetic agentBHU-DRA/ER/B0500121-Nov-1920-Nov-2022
92
91Expedited Registration Generic Drug ApplicationZamling Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseIbuprofen I.P...400mgBRUFEN 400Tablet15x4x15 TabletsBlister Each film coated tablet contains: Ibuprofen I.P...400mgAbbott India Limited.IndiaAnalgesicBHU-DRA/ER/B0500021-Nov-1920-Nov-2022
93
92Abridged RegistrationGeneric Drug ApplicationDepartment of Public Health, Ministry of Health, BhutanHuman Allopathic Medicine Human 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.,KoreaVaccineBHU-DRA/AR/B0498220-Nov-1919-Nov-2022
94
93Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseOxymetazoline Hydrochloride USP...0.5mgSinarest Nasal DropsDrops10 mlLupolene VialEach ml contains: Oxymetazoline Hydrochloride USP...0.5mgCentaur Pharmaceuticals Pvt. Ltd., Santacruz(E0,Mumbai 400 055 IndiaIndiaDecongestantBHU-DRA/ER/B0499720-Nov-1919-Nov-2022
95
94Full RegistrationGeneric Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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.IndiaAnti-EmeticBHU-DRA/B0499920-Nov-1919-Nov-2022
96
95Abridged RegistrationGeneric Drug ApplicationKarma Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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
96Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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 IndiaIndiaAntibioticBHU-DRA/ER/B0498620-Nov-1919-Nov-2022
98
97Expedited Registration Generic Drug ApplicationNamsey Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human UseBromhexine Hydrochloride BP...4 mgMucoten SyrupSyrup100 mlPET BottleEach 5 ml of syrup contains: Bromhexine Hydrochloride BP...4 mgESKAYEF BANGLADESH LIMITEDBangladeshMucolyticBHU-DRA/ER/B0499820-Nov-1919-Nov-2022
99
98Expedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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, IndiaIndiaanticoagulantBHU-DRA/ER/B0499312-Nov-1911-Nov-2022
100
99Expedited Registration Generic Drug ApplicationTsampaka Pharmaceutical and Medical SuppliesHuman Allopathic Medicine Human 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,IndiaIndiaAnalgesicBHU-DRA/ER/B0498312-Nov-1911-Nov-2022