Famciclovir

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ACTIVE PHARMA INGREDIENTS

39 API Suppliers, 11 USDMF, 5 JDMF, 5 EU WC, 15 KDMF, 8 NDC API, 16 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

18 Drugs in Development

18 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

126 FDF Dossiers, 27 FDA Orange Book, 50 Europe, 9 Canada, 26 Australia, 6 South Africa, 8 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 SPI Pharma, 12 DKSH, 5 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 28 BASF, 1 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 2 Esteem Industries, 1 Finar, 12 Gangwal Chemicals, 4 Ideal Cures, 2 Ingredion Pharma Solutions, 24 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 2 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 5 Pharmatrans-Sanaq, 4 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 15 Roquette, 12 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

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52 Fillers, Diluents & Binders, 43 Coating Systems & Additives, 38 Disintegrants & Superdisintegrants, 32 Direct Compression, 31 Granulation, 29 Thickeners and Stabilizers, 28 Solubilizers, 22 Lubricants & Glidants, 21 Controlled & Modified Release, 17 Topical, 14 Film Formers & Plasticizers, 11 Parenteral, 10 Chewable & Orodispersible Aids, 10 Co-Processed Excipients, 9 Emulsifying Agents, 7 Rheology Modifiers, 5 Empty Capsules, 5 API Stability Enhancers, 4 Taste Masking, 4 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

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USFDA APPLICATION NUMBER - 20363 / DOSAGE - TABLET;ORAL - 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FAMCICLOVIR(UNII: QIC03ANI02) (PENCICLOVIR - UNII:359HUE8FJC)	FAMCICLOVIR	500mg \| 250mg \| 125mg

Inactive Ingredients

Ingredient Name	Novartis Pharmaceuticals Corporation
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
LACTOSE(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid 3c6194c0 Ba69 4b16 B882 Caf736a02348 Applno 20363 Form Tablet Oral Dosage 125mg - Drug Product Composition: Famciclovir

Famciclovir

Famciclovir

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

39 API Suppliers

11 USDMF

5 JDMF

5 EU WC

15 KDMF

8 NDC API

16 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

18 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

126 FDF Dossiers

27 FDA Orange Book

50 Europe

9 Canada

26 Australia

6 South Africa

8 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

2 SPI Pharma

12 DKSH

5 Boai NKY Pharmaceuticals Ltd

6 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Kirsch Pharma

1 ACG Worldwide

5 Actylis

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

3 Ashland

28 BASF

1 Clariant

10 Corel Pharma Chem

7 DFE Pharma

2 Esteem Industries

1 Finar

12 Gangwal Chemicals

4 Ideal Cures

2 Ingredion Pharma Solutions

24 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

15 Microlex e.U

2 Nanjing Bold Chemical

3 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

5 Pharmatrans-Sanaq

4 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

15 Roquette

12 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

4 Silverline Chemicals

2 The Dow Chemical Company

1 Ulanqab Kema New Material

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

52 Fillers, Diluents & Binders

43 Coating Systems & Additives

TABLET;ORAL - 125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons