CDMO Activity Tracker: Lupin’s CDMO commissions oncology block in India; Cambrex, Axplora, Hovione expand operations

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Pipeline Prospector November 2025: Kimberly-Clark to buy Kenvue for US$ 48.7 bn; FDA approves Novartis’ gene therapy

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ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 9 USDMF, 8 CEP/COS, 1 JDMF, 4 EU WC, 12 NDC API, 12 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

111 FDF Dossiers, 53 FDA Orange Book, 9 Europe, 20 Canada, 6 South Africa, 23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CONCENTRATE;ORAL - 10MG/ML, TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 6 SPI Pharma, 1 DKSH, 4 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 6 Kirsch Pharma, 9 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 BASF, 1 CD Formulation, 5 DFE Pharma, 1 Esteem Industries, 2 Finar, 7 Gangwal Chemicals, 1 Ideal Cures, 2 Ingredion Pharma Solutions, 14 Kerry, 1 Keval Exports, 12 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 24 Roquette, 1 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 2 Silverline Chemicals, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

44 Fillers, Diluents & Binders, 26 Direct Compression, 22 Thickeners and Stabilizers, 18 Parenteral, 18 Granulation, 16 Lubricants & Glidants, 15 Film Formers & Plasticizers, 12 Taste Masking, 11 Co-Processed Excipients, 10 Topical, 9 Chewable & Orodispersible Aids, 9 Coating Systems & Additives, 7 Emulsifying Agents, 7 Disintegrants & Superdisintegrants, 7 Solubilizers, 6 Controlled & Modified Release, 1 Rheology Modifiers, 1 API Stability Enhancers, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

11 News #PharmaBuzz

11 News #PharmaBuzz

GLOBAL SALES INFORMATION

17 US Medicaid Prescriptions, 16 Regulatory FDF Prices

MARKET PLACE

8 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 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
30/12/2025	Siegfried AG	Switzerland	SIEGFRIED USA LLC	6231	METHADONE HYDROCHLORIDE USP	1986-03-11	Active	II	Complete	2013-07-31	2013-07-22
30/12/2025	Boehringer Ingelheim GmbH	Germany	BOEHRINGER INGELHEIM CHEMICALS INC	13942	METHADONE HYDROCHLORIDE USP	1999-01-18	Inactive	II	N/A

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

29 API Suppliers

9 USDMF

8 CEP/COS

1 JDMF

4 EU WC

12 NDC API

12 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

111 FDF Dossiers

53 FDA Orange Book

9 Europe

20 Canada

6 South Africa

23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CONCENTRATE;ORAL - 10MG/ML

TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Rochem International Inc

6 SPI Pharma

1 DKSH

4 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

1 Pfanstiehl

6 Kirsch Pharma

9 Actylis

1 Aeon Procare

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

6 BASF

1 CD Formulation

5 DFE Pharma

1 Esteem Industries

2 Finar

7 Gangwal Chemicals

1 Ideal Cures

2 Ingredion Pharma Solutions

14 Kerry

1 Keval Exports

12 Microlex e.U

2 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

1 Pharmatrans-Sanaq

4 Pluviaendo

2 Prachin Chemical

24 Roquette

1 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

9 Sigachi Industries

2 Silverline Chemicals

1 Valens Pharmachem

2 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

44 Fillers, Diluents & Binders

26 Direct Compression

22 Thickeners and Stabilizers

18 Parenteral

18 Granulation

16 Lubricants & Glidants

15 Film Formers & Plasticizers

12 Taste Masking

11 Co-Processed Excipients

10 Topical

9 Chewable & Orodispersible Aids

9 Coating Systems & Additives

7 Emulsifying Agents

7 Disintegrants & Superdisintegrants

TABLET;ORAL - 10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons