Lamivudine

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ACTIVE PHARMA INGREDIENTS

52 API Suppliers, 33 USDMF, 16 CEP/COS, 1 JDMF, 14 EU WC, 4 KDMF, 15 NDC API, 20 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

354 FDF Dossiers, 126 FDA Orange Book, 57 Europe, 23 Canada, 7 Australia, 111 South Africa, 30 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG, TABLET;ORAL - 150MG;200MG;300MG, TABLET;ORAL - 150MG, TABLET;ORAL - 300MG, TABLET;ORAL - 100MG;300MG;300MG, TABLET;ORAL - 300MG;300MG, TABLET;ORAL - EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 16 SPI Pharma, 2 Seqens, 4 DKSH, 5 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 25 BASF, 8 Beneo, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 19 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 45 Direct Compression, 33 Controlled & Modified Release, 32 Disintegrants & Superdisintegrants, 28 Thickeners and Stabilizers, 26 Solubilizers, 25 Granulation, 24 Taste Masking, 22 Co-Processed Excipients, 18 Chewable & Orodispersible Aids, 18 Parenteral, 15 Lubricants & Glidants, 15 Topical, 13 Film Formers & Plasticizers, 8 API Stability Enhancers, 8 Emulsifying Agents, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Rheology Modifiers, 3 Surfactant & Foaming Agents

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GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 49 Finished Drug Prices, 18 Annual Reports

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12 APIs, 10 FDF Dossiers

PATENTS & EXCLUSIVITIES

21 US Patents, 6 US Exclusivities, 20 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 4 USP, 9 Others

ANALYTICAL

1 BioAnalytical Methods, 1 Analytical Methods

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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)

Drug Product Composition: Lamivudine

Lamivudine

Lamivudine

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

52 API Suppliers

33 USDMF

16 CEP/COS

1 JDMF

14 EU WC

4 KDMF

15 NDC API

20 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

354 FDF Dossiers

126 FDA Orange Book

57 Europe

23 Canada

7 Australia

111 South Africa

30 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

TABLET;ORAL - 150MG;200MG;300MG

TABLET;ORAL - 150MG

TABLET;ORAL - 300MG

TABLET;ORAL - 100MG;300MG;300MG

TABLET;ORAL - 300MG;300MG

TABLET;ORAL - EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc

16 SPI Pharma

2 Seqens

4 DKSH

5 Faran Shimi Pharmaceutical

8 Boai NKY Pharmaceuticals Ltd

12 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

2 Pfanstiehl

1 ACG Worldwide

8 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

25 BASF

8 Beneo

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

2 Finar

12 Gangwal Chemicals

7 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

39 Kerry

3 Kima Chemical

6 Lonza Capsugel

15 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

4 Novo Excipients

4 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

19 Roquette

13 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

2 The Dow Chemical Company

TABLET;ORAL - EQ 600MG BASE;300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons