[[(2R)-1-(6-aminopurin-9-yl)propan-2-yl]oxymethyl-(propan-2-yloxycarbonyloxymethoxy)phosphoryl]oxymethyl propan-2-yl carbonate; (E)-but-2-enedioic acid | 211284 | TABLET;ORAL | 300MG;300MG

[[(2R)-1-(6-aminopurin-9-yl)propan-2-yl]oxymethyl-(propan-2-yloxycarbonyloxymethoxy)phosphoryl]oxymethyl propan-2-yl carbonate;(E)-but-2-enedioic acid

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ACTIVE PHARMA INGREDIENTS

85 API Suppliers, 30 USDMF, 21 EU WC, 23 KDMF, 21 NDC API, 41 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

167 Drugs in Development

167 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

338 FDF Dossiers, 85 FDA Orange Book, 87 Europe, 30 Canada, 21 Australia, 93 South Africa, 22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG;EQ 25MG BASE;300MG, TABLET;ORAL - 150MG;150MG;200MG;300MG, TABLET;ORAL - 100MG;300MG;300MG, TABLET;ORAL - 300MG;300MG, TABLET;ORAL - 150MG, TABLET;ORAL - 200MG, TABLET;ORAL - 250MG, TABLET;ORAL - 300MG, TABLET;ORAL - 100MG;150MG, TABLET;ORAL - 133MG;200MG, TABLET;ORAL - 167MG;250MG, TABLET;ORAL - 200MG;300MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 17 SPI Pharma, 6 DKSH, 8 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 2 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 31 BASF, 1 Clariant, 11 Corel Pharma Chem, 5 DFE Pharma, 1 Esteem Industries, 1 Finar, 12 Gangwal Chemicals, 5 Ideal Cures, 4 Ingredion Pharma Solutions, 22 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 15 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Vasa Pharmachem

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PATENTS & EXCLUSIVITIES

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REF. STANDARDS & IMPURITIES

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ANALYTICAL

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USFDA APPLICATION NUMBER - 211284 / DOSAGE - TABLET;ORAL - 300MG;300MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LAMIVUDINE(UNII: 2T8Q726O95) (LAMIVUDINE - UNII:2T8Q726O95)	LAMIVUDINE	300mg
TENOFOVIR DISOPROXIL FUMARATE(UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)	TENOFOVIR DISOPROXIL FUMARATE	300mg

Inactive Ingredients

Ingredient Name	CELLTRION, INC.
CROSCARMELLOSE SODIUM(M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POWDERED CELLULOSE(SMD1X3XO9M)
SILICON DIOXIDE(ETJ7Z6XBU4)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid B069bc8e Db09 4d2c B8b6 5438db4a24a2 Applno 211284 Form Tablet Oral Dosage 300mg 300mg - Drug Product Composition: [[(2R)-1-(6-aminopurin-9-yl)propan-2-yl]oxymethyl-(propan-2-yloxycarbonyloxymethoxy)phosphoryl]oxymethyl propan-2-yl carbonate; (E)-but-2-enedioic acid