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ACTIVE PHARMA INGREDIENTS

21 API Suppliers, 9 USDMF, 3 CEP/COS, 1 JDMF, 5 EU WC, 4 NDC API, 11 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

81 FDF Dossiers, 54 FDA Orange Book, 4 Europe, 1 Canada, 2 South Africa, 20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 14 Rochem International Inc, 22 SPI Pharma, 2 Seqens, 18 DKSH, 3 Jai Radhe Sales, 2 Pharm-RX Chemical, 6 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 10 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 11 Actylis, 2 Aeon Procare, 3 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 36 BASF, 1 Bioplus Life Sciences, 2 Clariant, 15 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 13 Gangwal Chemicals, 11 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 34 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 12 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 35 Roquette, 17 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

111 Fillers, Diluents & Binders, 75 Coating Systems & Additives, 51 Thickeners and Stabilizers, 47 Direct Compression, 45 Controlled & Modified Release, 41 Solubilizers, 39 Taste Masking, 30 Granulation, 30 Topical, 30 Parenteral, 29 Film Formers & Plasticizers, 29 Lubricants & Glidants, 26 Disintegrants & Superdisintegrants, 23 Chewable & Orodispersible Aids, 22 Co-Processed Excipients, 14 Emulsifying Agents, 13 Rheology Modifiers, 11 API Stability Enhancers, 9 Empty Capsules, 7 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 14 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 11 Finished Drug Prices

MARKET PLACE

17 APIs, 1 Intermediates

PATENTS & EXCLUSIVITIES

12 Health Canada Patents

12 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 USP, 2 JP, 4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical 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	Aarti Drugs	India	AARTI DRUGS LTD	20051	NIACIN	2006-12-14	Active	II	Complete	2013-04-10	2013-04-03
28/10/2024	Divis Laboratories	India	DIVIS LABORATORIES LTD	18481	NIACIN USP	2005-07-05	Active	II	Complete	2013-01-08	2012-12-06

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

21 API Suppliers

9 USDMF

3 CEP/COS

1 JDMF

5 EU WC

4 NDC API

11 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

81 FDF Dossiers

54 FDA Orange Book

4 Europe

1 Canada

2 South Africa

20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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

TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

2 Evonik

14 Rochem International Inc

22 SPI Pharma

2 Seqens

18 DKSH

3 Jai Radhe Sales

2 Pharm-RX Chemical

6 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

15 Gangwal Healthcare

10 Nanjing Well Pharmaceutical

2 Pfanstiehl

4 ACG Worldwide

11 Actylis

2 Aeon Procare

3 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

36 BASF

1 Bioplus Life Sciences

2 Clariant

15 Corel Pharma Chem

5 DFE Pharma

2 Finar

13 Gangwal Chemicals

11 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

34 Kerry

5 Kima Chemical

6 Lonza Capsugel

19 Microlex e.U

1 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

3 Novo Excipients

3 Pharmatrans-Sanaq

12 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

35 Roquette

17 Seppic

7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

3 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

4 The Dow Chemical Company

3 Ulanqab Kema New Material

2 Valens Pharmachem

3 Vasa Pharmachem

2 Zhejiang Huakang Pharmaceutical

TABLET, EXTENDED RELEASE;ORAL - 1GM Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

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

TABLET, EXTENDED RELEASE;ORAL - 750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons