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ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 7 USDMF, 1 JDMF, 5 NDC API, 3 Listed Suppliers

DEVELOPMENTS

18 Drugs in Development

18 Drugs in Development

FINISHED DOSAGE FORMULATIONS

28 FDF Dossiers, 19 FDA Orange Book, 3 Europe, 3 Canada, 1 South Africa, 2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 2MG/ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 5 Rochem International Inc, 18 SPI Pharma, 11 DKSH, 1 Pharm-RX Chemical, 5 Faran Shimi Pharmaceutical, 2 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 13 Actylis, 2 Aeon Procare, 1 Alcedo Pharmachem, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 14 BASF, 1 Corel Pharma Chem, 4 DFE Pharma, 4 Finar, 10 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 1 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 24 Kerry, 3 Lubrizol Life Science Health, 15 Microlex e.U, 1 Nanjing Bold Chemical, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 7 Pluviaendo, 2 Prachin Chemical, 27 Roquette, 11 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 Silverline Chemicals, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

80 Fillers, Diluents & Binders, 35 Topical, 35 Parenteral, 31 Direct Compression, 27 Solubilizers, 25 Thickeners and Stabilizers, 22 Taste Masking, 19 Film Formers & Plasticizers, 16 Granulation, 16 Chewable & Orodispersible Aids, 16 Lubricants & Glidants, 16 Co-Processed Excipients, 15 Coating Systems & Additives, 14 Emulsifying Agents, 12 Controlled & Modified Release, 11 Disintegrants & Superdisintegrants, 7 Surfactant & Foaming Agents, 5 Rheology Modifiers, 4 API Stability Enhancers, 1 Soft Gelatin

DIGITAL CONTENT

34 News #PharmaBuzz

34 News #PharmaBuzz

GLOBAL SALES INFORMATION

2 Regulatory FDF Prices

2 Regulatory FDF Prices

MARKET PLACE

2 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Exclusivities

2 US Exclusivities

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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
25/04/2025	ChemWerth Inc	U.S.A	CHEMWERTH INC	26075	ARSENIC TRIOXIDE	2012-05-18	Active	II	Complete	2015-02-06	2014-04-07
25/04/2025	ChemCon GmbH	Germany	CHEMCON GMBH	33758	ARSENIC TRIOXIDE	2019-06-07	Active	II	Complete	2019-08-12	2019-06-14

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers

7 USDMF

1 JDMF

5 NDC API

3 Listed Suppliers

DEVELOPMENTS

18 Drugs in Development

FINISHED DOSAGE FORMULATIONS

28 FDF Dossiers

19 FDA Orange Book

3 Europe

3 Canada

1 South Africa

2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 2MG/ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI

5 Rochem International Inc

18 SPI Pharma

11 DKSH

1 Pharm-RX Chemical

5 Faran Shimi Pharmaceutical

2 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

9 Nanjing Well Pharmaceutical

2 Pfanstiehl

13 Actylis

2 Aeon Procare

1 Alcedo Pharmachem

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

14 BASF

1 Corel Pharma Chem

4 DFE Pharma

4 Finar

10 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

1 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

24 Kerry

3 Lubrizol Life Science Health

15 Microlex e.U

1 Nanjing Bold Chemical

1 Novo Excipients

1 Pharmatrans-Sanaq

7 Pluviaendo

2 Prachin Chemical

27 Roquette

11 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

2 Shijiazhuang Huaxu Pharmaceutical

10 Sigachi Industries

2 Silverline Chemicals

1 Valens Pharmachem

2 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

80 Fillers, Diluents & Binders

35 Topical

35 Parenteral

31 Direct Compression

27 Solubilizers

25 Thickeners and Stabilizers

22 Taste Masking

19 Film Formers & Plasticizers

16 Granulation

16 Chewable & Orodispersible Aids

16 Lubricants & Glidants

16 Co-Processed Excipients

15 Coating Systems & Additives

14 Emulsifying Agents

12 Controlled & Modified Release

INJECTABLE;INJECTION - 1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons