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Zhejiang Hengkang Mesalazine Zhejiang Hengkang Mesalazine

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List of Drug Master Files (JDMF) for Prestwick3_001069 Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 PharmaZell (India) Private Limited (1)

02 PharmaZell GmbH (2)

03 Zhejiang Hengkang Pharmaceutical Co. , Ltd. (2)

04 Bayer Pharma AG (1)

05 CHEMI S. p. A. (1)

06 Cadila Healthcare Limited (1)

07 Cambrex Karlskoga AB (1)

08 DIVI'S LABORATORIES LIMITED (1)

09 ERREGIERRE S. p. A. (2)

10 SUN PHARMACEUTICAL INDUSTRIES LTD. (1)

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01 5-amino salicylic acid, SH grade (1)

02 Mesalazine (11)

03 Mesalazine (production only) (1)

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01 China (2)

02 Germany (4)

03 India (3)

04 Italy (3)

05 U.S.A (1)

219MF10036
ROSENHEIMER STR. 43 D-83064 RAUBLIN...
2016-02-02
2007-02-13
Axplora CB

2024 ACI Convention

Not Confirmed

envelop Contact Supplier
226MF10064
Plot No. 115, Ramky Pharma City (In...
2014-03-11
2014-03-11
Axplora CB

2024 ACI Convention

Not Confirmed

envelop Contact Supplier
226MF10019
ROSENHEIMER STR. 43 D-83064 RAUBLIN...
2014-01-21
2014-01-21
Axplora CB

2024 ACI Convention

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
224MF10001
13353 Berlin, Muellerstrasse 178, G...
2012-01-16
2012-01-16
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URL Supplier Web Content
220MF10007
SE-691 85 Karlskoga, SWEDEN
2009-07-14
2008-01-09
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URL Supplier Web Content
219MF10131
Via dei Laboratori 54, 20092 Cinise...
2023-08-22
2007-04-18
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231MF10004
1-72/23(P)/DIVIS/303, Divi Towers, ...
2019-01-10
2019-01-10
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303MF10044
Zydus Corporate Park, 3rd Floor, B ...
2021-03-15
2021-03-15
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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)

Prestwick3_001069 Manufacturers

A Prestwick3_001069 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prestwick3_001069, including repackagers and relabelers. The FDA regulates Prestwick3_001069 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prestwick3_001069 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 Prestwick3_001069 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Prestwick3_001069 Suppliers

A Prestwick3_001069 supplier is an individual or a company that provides Prestwick3_001069 active pharmaceutical ingredient (API) or Prestwick3_001069 finished formulations upon request. The Prestwick3_001069 suppliers may include Prestwick3_001069 API manufacturers, exporters, distributors and traders.

click here to find a list of Prestwick3_001069 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Prestwick3_001069 JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Prestwick3_001069 Drug Master File in Japan (Prestwick3_001069 JDMF) empowers Prestwick3_001069 API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Prestwick3_001069 JDMF during the approval evaluation for pharmaceutical products. At the time of Prestwick3_001069 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Prestwick3_001069 suppliers with JDMF on PharmaCompass.

Prestwick3_001069 Manufacturers | Traders | Suppliers

Prestwick3_001069 Manufacturers, Traders, Suppliers 1
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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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