FDA approvals drop 8% in 2025, with fewer blockbusters; Brinsupri, Rhapsido make it to first-in-class list

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Stock Recap
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Mesalazina [Spanish]

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ACTIVE PHARMA INGREDIENTS

110 API Suppliers, 53 USDMF, 36 CEP/COS, 13 JDMF, 15 EU WC, 11 KDMF, 37 NDC API, 47 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

41 Drugs in Development

41 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

691 FDF Dossiers, 45 FDA Orange Book, 510 Europe, 18 Canada, 48 Australia, 17 South Africa, 53 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

ENEMA;RECTAL - 4GM/60ML, CAPSULE, EXTENDED RELEASE;ORAL - 250MG, CAPSULE, EXTENDED RELEASE;ORAL - 500MG, CAPSULE, DELAYED RELEASE;ORAL - 400MG, SUPPOSITORY;RECTAL - 1GM, TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 1.2GM, CAPSULE, EXTENDED RELEASE;ORAL - 375MG

RELATED EXCIPIENT COMPANIES

8 Evonik, 3 Rochem International Inc, 1 SPI Pharma, 1 Pharm-RX Chemical, 5 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Kirsch Pharma, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 31 BASF, 1 CD Formulation, 15 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 1 Esteem Industries, 1 Finar, 9 Gangwal Chemicals, 12 Ideal Cures, 1 Ingredion Pharma Solutions, 20 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 17 Microlex e.U, 1 Neelkanth MineChem, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 13 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

63 Coating Systems & Additives, 43 Fillers, Diluents & Binders, 39 Controlled & Modified Release, 33 Thickeners and Stabilizers, 28 Disintegrants & Superdisintegrants, 27 Solubilizers, 25 Granulation, 23 Direct Compression, 17 Lubricants & Glidants, 14 Film Formers & Plasticizers, 13 Topical, 11 Taste Masking, 9 Chewable & Orodispersible Aids, 9 Empty Capsules, 8 Co-Processed Excipients, 6 Rheology Modifiers, 5 Emulsifying Agents, 5 Parenteral, 5 API Stability Enhancers, 4 Vegetarian Capsules, 2 Coloring Agents, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 72 News #PharmaBuzz

GLOBAL SALES INFORMATION

41 US Medicaid Prescriptions, 119 Regulatory FDF Prices, 37 Annual Reports

MARKET PLACE

27 APIs, 14 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents, 10 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 22 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Labeler	NDC Package Code	Non Proprietary Name	Start Marketing Date	End Marketing Date	Category Code	Dosage Form (Strength)
27/02/2026	Axplora	Germany	PharmaZell GmbH	12598-5152	Mesalazine	2001-04-01	2026-12-31	BULK INGREDIENT	POWDER (1kg/kg)
27/02/2026	PharmaZell	Germany	PharmaZell GmbH	12598-5151	Mesalazine	2001-04-01	2026-12-31	BULK INGREDIENT	POWDER (1kg/kg)

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

Mesalazina [Spanish]

Mesalazina [Spanish]

ACCESS ALL DATA

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

110 API Suppliers

53 USDMF

36 CEP/COS

13 JDMF

15 EU WC

11 KDMF

37 NDC API

47 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

41 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

691 FDF Dossiers

45 FDA Orange Book

510 Europe

18 Canada

48 Australia

17 South Africa

53 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

ENEMA;RECTAL - 4GM/60ML

CAPSULE, EXTENDED RELEASE;ORAL - 250MG

CAPSULE, EXTENDED RELEASE;ORAL - 500MG

CAPSULE, DELAYED RELEASE;ORAL - 400MG

SUPPOSITORY;RECTAL - 1GM

TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, DELAYED RELEASE;ORAL - 1.2GM

CAPSULE, EXTENDED RELEASE;ORAL - 375MG

RELATED EXCIPIENT COMPANIES

8 Evonik

3 Rochem International Inc

1 SPI Pharma

1 Pharm-RX Chemical

5 Boai NKY Pharmaceuticals Ltd

4 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

2 Kirsch Pharma

4 ACG Worldwide

3 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

3 Ashland

31 BASF

1 CD Formulation

15 Corel Pharma Chem

5 DFE Pharma

3 Doshion Polyscience

1 Esteem Industries

1 Finar

9 Gangwal Chemicals

12 Ideal Cures

1 Ingredion Pharma Solutions

20 Kerry

3 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

2 Lubrizol Life Science Health

17 Microlex e.U

1 Neelkanth MineChem

2 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

3 Novo Excipients

4 Pharmatrans-Sanaq

3 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

13 Roquette

6 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

10 Sigachi Industries

TABLET, DELAYED RELEASE;ORAL - 800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons