Antibiotic market to reach US$ 74.07 billion by 2033; FDA approves GSK’s Blujepa for uncomplicated UTIs

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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

39 API Suppliers, 19 USDMF, 6 CEP/COS, 6 EU WC, 20 NDC API, 12 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

39 Drugs in Development

39 Drugs in Development

FINISHED DOSAGE FORMULATIONS

207 FDF Dossiers, 121 FDA Orange Book, 44 Europe, 14 Canada, 8 Australia, 4 South Africa, 16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Rochem International Inc, 5 SPI Pharma, 7 DKSH, 1 Pharm-RX Chemical, 8 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 21 BASF, 1 CD Formulation, 1 Clariant, 11 Corel Pharma Chem, 6 DFE Pharma, 12 Gangwal Chemicals, 4 Ideal Cures, 4 Ingredion Pharma Solutions, 20 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 25 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

60 Fillers, Diluents & Binders, 43 Coating Systems & Additives, 40 Disintegrants & Superdisintegrants, 32 Direct Compression, 31 Granulation, 26 Thickeners and Stabilizers, 22 Solubilizers, 20 Controlled & Modified Release, 18 Parenteral, 17 Lubricants & Glidants, 15 Taste Masking, 13 Co-Processed Excipients, 12 Film Formers & Plasticizers, 11 Chewable & Orodispersible Aids, 10 Topical, 9 Rheology Modifiers, 7 API Stability Enhancers, 7 Emulsifying Agents, 5 Empty Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

1 Stock Recap #PipelineProspector, 34 News #PharmaBuzz

GLOBAL SALES INFORMATION

28 US Medicaid Prescriptions, 17 Regulatory FDF Prices

MARKET PLACE

13 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

8 US Patents

8 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 4 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
29/11/2025	Enaltec Labs	India	ENALTEC LABS PRIVATE LTD	31386	CLONIDINE HYDROCHLORIDE USP	2017-08-28	Active	II	Complete	2018-03-01	2017-10-27
29/11/2025	Seqens	France	PCAS	4778	CLONIDINE HYDROCHLORIDE	1983-01-21	Active	II	Complete	2015-01-29	2015-01-16

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

39 API Suppliers

19 USDMF

6 CEP/COS

6 EU WC

20 NDC API

12 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

39 Drugs in Development

FINISHED DOSAGE FORMULATIONS

207 FDF Dossiers

121 FDA Orange Book

44 Europe

14 Canada

8 Australia

4 South Africa

16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI

1 Rochem International Inc

5 SPI Pharma

7 DKSH

1 Pharm-RX Chemical

8 Boai NKY Pharmaceuticals Ltd

5 Gangwal Healthcare

3 Nanjing Well Pharmaceutical

1 Pfanstiehl

3 Kirsch Pharma

1 ACG Worldwide

9 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

21 BASF

1 CD Formulation

1 Clariant

11 Corel Pharma Chem

6 DFE Pharma

12 Gangwal Chemicals

4 Ideal Cures

4 Ingredion Pharma Solutions

20 Kerry

3 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

12 Microlex e.U

1 Nanjing Bold Chemical

2 Nitika Pharmaceutical Specialities

3 Novo Excipients

4 Pharmatrans-Sanaq

7 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

25 Roquette

13 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

11 Sigachi Industries

4 Silverline Chemicals

2 The Dow Chemical Company

2 Ulanqab Kema New Material

4 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

60 Fillers, Diluents & Binders

TABLET;ORAL - 0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons