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Cephalexin

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ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 21 USDMF, 4 JDMF, 1 EU WC, 5 NDC API, 4 Listed Suppliers, $ API Reference Price

INTERMEDIATES

4 Intermediates Suppliers

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

162 FDF Dossiers, 97 FDA Orange Book, 6 Europe, 6 Canada, 2 South Africa, 51 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

4 Rochem International Inc, 6 SPI Pharma, 12 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 6 Faran Shimi Pharmaceutical, 12 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 9 BASF, 1 Clariant, 7 DFE Pharma, 2 Finar, 9 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 26 Kerry, 1 Kima Chemical, 3 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 4 Prachin Chemical, 1 Qualicaps, 23 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 12 Sigachi Industries, 1 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

68 Fillers, Diluents & Binders, 33 Direct Compression, 33 Thickeners and Stabilizers, 28 Disintegrants & Superdisintegrants, 19 Granulation, 18 Solubilizers, 17 Coating Systems & Additives, 16 Co-Processed Excipients, 16 Lubricants & Glidants, 14 Taste Masking, 13 Topical, 10 Parenteral, 10 Film Formers & Plasticizers, 9 Rheology Modifiers, 8 Empty Capsules, 8 Controlled & Modified Release, 7 Emulsifying Agents, 6 Chewable & Orodispersible Aids, 4 Surfactant & Foaming Agents, 3 API Stability Enhancers, 3 Coloring Agents

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 16 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 12 Finished Drug Prices

MARKET PLACE

14 APIs, 4 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 USP, 10 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	Aurobindo Pharma Limited	India	APITORIA PHARMA PRIVATE LTD	17604	CEPHALEXIN USP	2004-07-31	Active	II	N/A
28/10/2024	Aurobindo Pharma Limited	India	APITORIA PHARMA PRIVATE LTD	32930	CEPHALEXIN USP (ENZYMATIC ROUTE)	2019-03-29	Active	II	Complete	2019-05-07	2019-03-29

Cephalexin

Cephalexin

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

27 API Suppliers

21 USDMF

4 JDMF

1 EU WC

5 NDC API

4 Listed Suppliers

$ API Reference Price

INTERMEDIATES

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

162 FDF Dossiers

97 FDA Orange Book

6 Europe

6 Canada

2 South Africa

51 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

CAPSULE;ORAL - EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

CAPSULE;ORAL - EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

4 Rochem International Inc

6 SPI Pharma

12 DKSH

2 Jai Radhe Sales

1 Pharm-RX Chemical

6 Faran Shimi Pharmaceutical

12 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

1 Pfanstiehl

4 ACG Worldwide

6 Actylis

1 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

9 BASF

1 Clariant

7 DFE Pharma

2 Finar

9 Gangwal Chemicals

1 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

26 Kerry

1 Kima Chemical

3 Lonza Capsugel

13 Microlex e.U

1 Nanjing Bold Chemical

2 Pharmatrans-Sanaq

6 Pluviaendo

4 Prachin Chemical

1 Qualicaps

23 Roquette

8 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

12 Sigachi Industries

1 The Dow Chemical Company

1 Valens Pharmachem

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

68 Fillers, Diluents & Binders

33 Direct Compression

33 Thickeners and Stabilizers

28 Disintegrants & Superdisintegrants

19 Granulation

18 Solubilizers

17 Coating Systems & Additives

16 Co-Processed Excipients

16 Lubricants & Glidants

14 Taste Masking

13 Topical

10 Parenteral

10 Film Formers & Plasticizers

9 Rheology Modifiers

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

CAPSULE;ORAL - EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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

CAPSULE;ORAL - EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons