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Zhejiang Hengkang Mesalazine Zhejiang Hengkang Mesalazine

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List of Drug Master Files (DMF) of 09410_FLUKA Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Axplora (1)

02 Zhejiang Hengkang Pharmaceutical (1)

03 IOL Chemicals and Pharmaceuticals (1)

04 ALP Pharm (1)

05 Ajinomoto OmniChem N.V. (1)

06 Alkem Laboratories (1)

07 Alvogen (1)

08 Amoli Organics (1)

09 Aurobindo Pharma Limited (1)

10 BEC Chemicals Pvt. Ltd (1)

11 Bayer AG (1)

12 CTX Lifesciences (1)

13 Cambrex Corporation (2)

14 Chemi SpA (3)

15 Cilag AG (1)

16 Corden Pharma Bergamo S.p.A (2)

17 Daiwa Chemical Industries (1)

18 Dasami Lab (1)

19 Divis Laboratories (1)

20 Eastman Chemical Company (1)

21 Erregierre SpA (2)

22 INFAR S.A. (1)

23 Institute Molecular biology (1)

24 Ipca Laboratories (3)

25 Lupin Ltd (2)

26 Maithri Drugs (1)

27 Optimus Pharma (1)

28 Pliva Hrvatska (1)

29 RANBAXY LABORATORIES LIMITED (1)

30 SIGMA TAU (1)

31 SIMS Srl (1)

32 Signa S.A. de C.V. (1)

33 Solara Active Pharma Sciences (1)

34 Sun Pharmaceutical Industries Limited (2)

35 Syntese AS (1)

36 Teva API (1)

37 The Dow Chemical Company (1)

38 Viatris (1)

39 Waitaki Biosciences (1)

40 Wanbury Limited (1)

41 Zydus Lifesciences (2)

42 Blank (1)

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01 5-AMINOSALICYLIC ACID (4)

02 5-AMINOSALICYLIC ACID (MESALAZINE/MESALAMINE) (1)

03 5-AMINOSALICYLIC ACID DOSAGE FORM FOR CLINICAL RESEARCH (1)

04 5-AMINOSALICYLIC ACID I (MESALAMINE) (1)

05 5-ASA CRUDE (5-AMINOSALICYLIC ACID CRUDE) (1)

06 ASACOL (5-AMINOSALICYLIC ACID) TABLETS (1)

07 ASACOL TABLETS (1)

08 MESALAMINE (6)

09 MESALAMINE (5-AMINOSALICYLIC ACID) DRUG SUBSTANCE (1)

10 MESALAMINE CRYSTALLIZED, USP (1)

11 MESALAMINE HIGH DENSITY (1)

12 MESALAMINE USP (19)

13 MESALAMINE USP (5-AMINO SALICYLIC ACID) (1)

14 MESALAMINE USP (MZ3 PROCESS) (1)

15 MESALAMINE USP (PROCESS II) (1)

16 MESALAMINE USP (PROCESS-II) (1)

17 MESALAMINE USP - PH.EUR. (HIGH DENSITY) (1)

18 MESALAMINE USP-EP (1)

19 MESALAMINE/5-AMINOSALICYLIC ACID (1)

20 MESALAZINE (2)

21 MESALAZINE N (1)

22 SALOFALK 250MG MESALAMINE ENTERIC COATED TABLETS (1)

23 TERMINAL STERILIZATION PROGRAM IN GRAND ISLAND, NEW YORK. (1)

24 TERMINAL STERILZATION PROGRAM IN MELROSE PARK, ILLINOIS. (1)

25 TOXICITY REPORTS FOR KOLLICOATS RS 30 D PROCESSS FACILITY (1)

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01 Belgium (1)

02 China (2)

03 Croatia (1)

04 Denmark (1)

05 Germany (3)

06 India (22)

07 Israel (1)

08 Italy (8)

09 Japan (1)

10 Mexico (1)

11 New Zealand (1)

12 Spain (1)

13 Switzerland (1)

14 U.S.A (7)

15 Blank (1)

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01 Active (29)

02 Inactive (23)

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01 Complete (18)

02 Blank (34)

8070
Active
1989-05-09
Complete
2014-12-16
2014-11-28
II
Axplora CB

CPhI Japan

Not Confirmed

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7655
Active
1988-09-01
N/A
II
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5693
Active
1985-01-24
Complete
2013-03-28
2013-03-18
II
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11951
Active
1996-04-29
Complete
2012-12-27
2012-11-19
II
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11807
Active
1996-01-15
Complete
2015-04-21
2014-10-22
II
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13883
Active
1998-12-03
Complete
2015-09-28
2015-09-18
II
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18742
Active
2005-09-09
N/A
II
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19618
Active
2006-07-21
N/A
II
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Looking for 89-57-6 / Mesalazine API manufacturers, exporters & distributors?

Mesalazine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Mesalazine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Mesalazine manufacturer or Mesalazine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mesalazine manufacturer or Mesalazine supplier.

PharmaCompass also assists you with knowing the Mesalazine API Price utilized in the formulation of products. Mesalazine API Price is not always fixed or binding as the Mesalazine Price is obtained through a variety of data sources. The Mesalazine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Mesalazine

Synonyms

5-aminosalicylic acid, 89-57-6, 5-amino-2-hydroxybenzoic acid, Asacol, Pentasa, Canasa

Cas Number

89-57-6

Unique Ingredient Identifier (UNII)

4Q81I59GXC

About Mesalazine

An anti-inflammatory agent, structurally related to the SALICYLATES, which is active in INFLAMMATORY BOWEL DISEASE. It is considered to be the active moiety of SULPHASALAZINE. (From Martindale, The Extra Pharmacopoeia, 30th ed)

09410_FLUKA Manufacturers

A 09410_FLUKA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 09410_FLUKA, including repackagers and relabelers. The FDA regulates 09410_FLUKA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 09410_FLUKA API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of 09410_FLUKA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

09410_FLUKA Suppliers

A 09410_FLUKA supplier is an individual or a company that provides 09410_FLUKA active pharmaceutical ingredient (API) or 09410_FLUKA finished formulations upon request. The 09410_FLUKA suppliers may include 09410_FLUKA API manufacturers, exporters, distributors and traders.

click here to find a list of 09410_FLUKA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

09410_FLUKA USDMF

A 09410_FLUKA DMF (Drug Master File) is a document detailing the whole manufacturing process of 09410_FLUKA active pharmaceutical ingredient (API) in detail. Different forms of 09410_FLUKA DMFs exist exist since differing nations have different regulations, such as 09410_FLUKA USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 09410_FLUKA DMF submitted to regulatory agencies in the US is known as a USDMF. 09410_FLUKA USDMF includes data on 09410_FLUKA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 09410_FLUKA USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 09410_FLUKA suppliers with USDMF on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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