Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

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Diovan

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ACTIVE PHARMA INGREDIENTS

107 API Suppliers, 45 USDMF, 43 CEP/COS, 27 JDMF, 24 EU WC, 77 KDMF, 19 NDC API, 55 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

17 Drugs in Development

17 Drugs in Development

INTERMEDIATES

28 Intermediates Suppliers

28 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

1543 FDF Dossiers, 267 FDA Orange Book, 873 Europe, 69 Canada, 14 Australia, 103 South Africa, 217 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 5MG BASE;80MG, TABLET;ORAL - 12.5MG;160MG, TABLET;ORAL - 12.5MG;320MG, TABLET;ORAL - 12.5MG;80MG, TABLET;ORAL - 25MG;160MG, TABLET;ORAL - 25MG;320MG, TABLET;ORAL - 160MG, TABLET;ORAL - 320MG, TABLET;ORAL - 40MG, TABLET;ORAL - 80MG, TABLET;ORAL - EQ 10MG BASE;160MG, TABLET;ORAL - EQ 10MG BASE;320MG, TABLET;ORAL - EQ 5MG BASE;160MG, TABLET;ORAL - EQ 5MG BASE;320MG, TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;160MG, TABLET;ORAL - EQ 10MG BASE;25MG;320MG, TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG, TABLET;ORAL - EQ 5MG BASE;25MG;160MG

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 16 SPI Pharma, 2 Seqens, 4 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 10 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 35 BASF, 1 Bioplus Life Sciences, 2 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 16 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 5 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 20 Roquette, 15 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

102 Fillers, Diluents & Binders, 55 Coating Systems & Additives, 53 Direct Compression, 42 Disintegrants & Superdisintegrants, 36 Controlled & Modified Release, 35 Solubilizers, 33 Granulation, 29 Thickeners and Stabilizers, 24 Film Formers & Plasticizers, 23 Topical, 23 Parenteral, 22 Co-Processed Excipients, 21 Taste Masking, 20 Lubricants & Glidants, 17 Chewable & Orodispersible Aids, 11 Emulsifying Agents, 8 Surfactant & Foaming Agents, 8 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules

DIGITAL CONTENT

10 DATA COMPILATION #PharmaFlow, 287 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 755 Finished Drug Prices, 15 Annual Reports

MARKET PLACE

35 APIs, 10 FDF Dossiers

PATENTS & EXCLUSIVITIES

45 US Patents, 6 US Exclusivities, 10 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 5 USP, 4 JP, 22 Others

ANALYTICAL

2 BioAnalytical Methods, 3 Analytical Methods

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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	Biophore India Pharmaceuticals Pvt Ltd	India	BIOPHORE INDIA PHARMACEUTICALS PVT LTD	35510	Valsartan	2020-12-29	Active	II	Complete	2021-11-15	2021-09-28
28/10/2024	Dr. Reddy\'s Laboratories	India	DR REDDYS LABORATORIES LTD	20319	VALSARTAN	2007-03-02	Active	II	Complete	2013-06-24	2013-06-12

Diovan

Diovan

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

107 API Suppliers

45 USDMF

43 CEP/COS

27 JDMF

24 EU WC

77 KDMF

19 NDC API

55 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

17 Drugs in Development

INTERMEDIATES

28 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

1543 FDF Dossiers

267 FDA Orange Book

873 Europe

69 Canada

14 Australia

103 South Africa

217 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 5MG BASE;80MG

TABLET;ORAL - 12.5MG;160MG

TABLET;ORAL - 12.5MG;320MG

TABLET;ORAL - 12.5MG;80MG

TABLET;ORAL - 25MG;160MG

TABLET;ORAL - 25MG;320MG

TABLET;ORAL - 160MG

TABLET;ORAL - 320MG

TABLET;ORAL - 40MG

TABLET;ORAL - 80MG

TABLET;ORAL - EQ 10MG BASE;160MG

TABLET;ORAL - EQ 10MG BASE;320MG

TABLET;ORAL - EQ 5MG BASE;160MG

TABLET;ORAL - EQ 5MG BASE;320MG

TABLET;ORAL - EQ 10MG BASE;12.5MG;160MG

TABLET;ORAL - EQ 10MG BASE;25MG;160MG

TABLET;ORAL - EQ 10MG BASE;25MG;320MG

TABLET;ORAL - EQ 5MG BASE;12.5MG;160MG

TABLET;ORAL - EQ 5MG BASE;25MG;160MG

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc

16 SPI Pharma

2 Seqens

4 DKSH

2 Jai Radhe Sales

1 Pharm-RX Chemical

8 Faran Shimi Pharmaceutical

10 Boai NKY Pharmaceuticals Ltd

14 Gangwal Healthcare

10 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 ACG Worldwide

7 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Avesta Pharma

35 BASF

1 Bioplus Life Sciences

2 Clariant

10 Corel Pharma Chem

7 DFE Pharma

2 Finar

13 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

7 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

39 Kerry

3 Kima Chemical

6 Lonza Capsugel

16 Microlex e.U