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Niacin

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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

82 FDF Dossiers, 54 FDA Orange Book, 4 Europe, 1 Canada, 2 South Africa, 21 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TABLET, EXTENDED RELEASE;ORAL - 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 2 Pharm-RX Chemical, 10 Faran Shimi Pharmaceutical, 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, 8 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, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

109 Fillers, Diluents & Binders, 75 Coating Systems & Additives, 51 Thickeners and Stabilizers, 46 Direct Compression, 45 Controlled & Modified Release, 40 Solubilizers, 39 Taste Masking, 30 Granulation, 30 Topical, 30 Parenteral, 29 Film Formers & Plasticizers, 29 Lubricants & Glidants, 25 Disintegrants & Superdisintegrants, 23 Co-Processed Excipients, 23 Chewable & Orodispersible Aids, 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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Data in the table can be downloaded after upgrading. In the meantime, you can access the data through the menu.

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/11/2024	Aarti Drugs	India	AARTI DRUGS LTD	20051	NIACIN	2006-12-14	Active	II	Complete	2013-04-10	2013-04-03
28/11/2024	Divis Laboratories	India	DIVIS LABORATORIES LTD	18481	NIACIN USP	2005-07-05	Active	II	Complete	2013-01-08	2012-12-06

Niacin

Niacin

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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

82 FDF Dossiers

54 FDA Orange Book

4 Europe

1 Canada

2 South Africa

21 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

2 Pharm-RX Chemical

10 Faran Shimi Pharmaceutical

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

8 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

2 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