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Mesalazine

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ACTIVE PHARMA INGREDIENTS

92 API Suppliers, 53 USDMF, 36 CEP/COS, 13 JDMF, 14 EU WC, 10 KDMF, 37 NDC API, 42 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

453 FDF Dossiers, 42 FDA Orange Book, 293 Europe, 18 Canada, 40 Australia, 13 South Africa, 47 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- 1GM, TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 1.2GM, CAPSULE, EXTENDED RELEASE;ORAL - 375MG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, 14 DKSH, 1 Pharm-RX Chemical, 3 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 31 BASF, 15 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 1 Finar, 9 Gangwal Chemicals, 13 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 30 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 17 Microlex e.U, 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, 11 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

69 Coating Systems & Additives, 55 Fillers, Diluents & Binders, 43 Controlled & Modified Release, 39 Thickeners and Stabilizers, 28 Solubilizers, 27 Disintegrants & Superdisintegrants, 22 Granulation, 22 Direct Compression, 17 Lubricants & Glidants, 15 Film Formers & Plasticizers, 15 Topical, 11 Taste Masking, 11 Rheology Modifiers, 9 Empty Capsules, 8 Co-Processed Excipients, 7 Chewable & Orodispersible Aids, 5 API Stability Enhancers, 4 Parenteral, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Emulsifying Agents, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 68 News #PharmaBuzz

GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions, 200 Regulatory FDF Prices, 35 Annual Reports

MARKET PLACE

22 APIs, 14 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents, 13 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 1 USP, 15 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls download

Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Axplora	Germany	PHARMAZELL GMBH	8070	5-AMINOSALICYLIC ACID (MESALAZINE/MESALAMINE)	1989-05-09	Active	II	Complete	2014-12-16	2014-11-28
28/03/2025	Zhejiang Hengkang Pharmaceutical	China	ZHEJIANG HENGKANG PHARMACEUTICAL CO LTD	37319	MESALAMINE USP	2022-08-17	Active	II	Complete	2022-10-20	2022-09-16

Mesalazine

Mesalazine

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Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

92 API Suppliers

53 USDMF

36 CEP/COS

13 JDMF

14 EU WC

10 KDMF

37 NDC API

42 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

453 FDF Dossiers

42 FDA Orange Book

293 Europe

18 Canada

40 Australia

13 South Africa

47 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

14 DKSH

1 Pharm-RX Chemical

3 Faran Shimi Pharmaceutical

5 Boai NKY Pharmaceuticals Ltd

4 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

4 ACG Worldwide

3 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

31 BASF

15 Corel Pharma Chem

5 DFE Pharma

3 Doshion Polyscience

1 Finar

9 Gangwal Chemicals

13 Ideal Cures Pvt Ltd

1 Ingredion Pharma Solutions

30 Kerry

4 Kima Chemical

6 Lonza Capsugel

2 Lubrizol Life Science Health

17 Microlex e.U

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

11 Sigachi Industries

3 The Dow Chemical Company

1 Ulanqab Kema New Material

1 Valens Pharmachem

3 Vasa Pharmachem

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