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Zhejiang Hengkang Mesalazine Zhejiang Hengkang Mesalazine

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List of Certificates of Suitability (CEPs) for 09409_FLUKA Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 ZHEJIANG HENGKANG PHARMACEUTICAL CO., LTD. Sanmen CN (2)

02 A.H.A International Co., Ltd. Hefei CN (2)

03 AMOLI ORGANICS PRIVATE LIMITED Mumbai IN (1)

04 BAYER AG Leverkusen DE (1)

05 BEC CHEMICALS PRIVATE LIMITED Mumbai IN (2)

06 CAMBREX KARLSKOGA AB Karlskoga SE (2)

07 CHEMI S.P.A. Patrica IT (2)

08 CORDEN PHARMA BERGAMO S.P.A. Treviglio IT (2)

09 CTX LIFESCIENCES PVT. LIMITED Surat IN (1)

10 DIVI'S LABORATORIES LIMITED Hyderabad IN (1)

11 Erregierre S.p.A. San Paolo D'Argon IT (2)

12 HY-GRO CHEMICALS PHARMTEK PRIVATE LIMITED Secunderabad IN (1)

13 IPCA Laboratories Limited Mumbai IN (2)

14 JIANGSU JUBANG PHARMACEUTICAL CO., LTD. Liyang CN (1)

15 MAITHRI DRUGS PRIVATE LIMITED Bonthapally Village IN (1)

16 MERCK & CIE KMG Schaffhausen CH (1)

17 PLIVA CROATIA LTD. Zagreb HR (1)

18 PharmaZell GmbH Raubling DE (1)

19 S.A. AJINOMOTO OMNICHEM N.V. Louvain-La-Neuve BE (1)

20 SOLARA ACTIVE PHARMA SCIENCES LIMITED Chennai IN (1)

21 SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN (2)

22 Syntese A/S Hvidovre DK (2)

23 ZHEJIANG SANMEN HENGKANG PHARMACEUTICAL CO., LTD. Sanmen CN (1)

24 ZYDUS LIFESCIENCES LIMITED Vadodara IN (1)

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01 Mesalazine (21)

02 Mesalazine, Grade S (1)

03 Mesalazine, Grade SH (1)

04 Mesalazine, HP (1)

05 Mesalazine, High density (2)

06 Mesalazine, Mesalazine (MZ4B Process) (1)

07 Mesalazine, Micronised (2)

08 Mesalazine, Product codes: FV0945, FV0945C, FV0947 and FV0947C (1)

09 Mesalazine, Products codes: FV 0950 (milled), FV 0950C (milled), FV 0945D (milled), FV 0941 (high bulk density), FV 0941C (high bulk density), FV 0941A (high bulk density), FV 0941AC (high bulk density), FV 0941S (high bulk density), FV 0941SC (high bulk (1)

10 Mesalazine, Pubagang site (1)

11 Mesalazine, Regular density (1)

12 Mesalazine, Site II (1)

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01 China (6)

02 Croatia (1)

03 Denmark (2)

04 Gabon (1)

05 Germany (1)

06 India (13)

07 Italy (6)

08 Japan (1)

09 Switzerland (1)

10 U.S.A (2)

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01 Expired (2)

02 Valid (26)

03 Withdrawn by Holder (6)

URL Supplier Web Content
R1-CEP 2010-149 - Rev 00
Valid
Chemical
2015-08-17
1699
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R0-CEP 2020-167 - Rev 00
Valid
Chemical
2021-11-24
1699
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R1-CEP 2011-100 - Rev 00
Valid
Chemical
2017-06-29
1699
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R1-CEP 2003-243 - Rev 03
Valid
Chemical
2018-03-29
1699
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PHARMACOMPASS
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R1-CEP 2016-050 - Rev 01
Valid
Chemical
2022-11-08
1699
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PHARMACOMPASS
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R1-CEP 2016-246 - Rev 00
Valid
Chemical
2022-04-08
1699
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PharmaZell GmbH Raubling DE

Contact Supplier
Virtual Booth Virtual Booth
Digital Content Digital Content
URL Supplier Web Content
CEP 2003-203 - Rev 03
Valid
Chemical
2023-11-08
1699
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PHARMACOMPASS
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R0-CEP 2019-009 - Rev 01
Valid
Chemical
2022-07-07
1699
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PHARMACOMPASS
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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)

09409_FLUKA Manufacturers

A 09409_FLUKA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 09409_FLUKA, including repackagers and relabelers. The FDA regulates 09409_FLUKA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 09409_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 09409_FLUKA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

09409_FLUKA Suppliers

A 09409_FLUKA supplier is an individual or a company that provides 09409_FLUKA active pharmaceutical ingredient (API) or 09409_FLUKA finished formulations upon request. The 09409_FLUKA suppliers may include 09409_FLUKA API manufacturers, exporters, distributors and traders.

click here to find a list of 09409_FLUKA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

09409_FLUKA CEP

A 09409_FLUKA CEP of the European Pharmacopoeia monograph is often referred to as a 09409_FLUKA Certificate of Suitability (COS). The purpose of a 09409_FLUKA CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 09409_FLUKA EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 09409_FLUKA to their clients by showing that a 09409_FLUKA CEP has been issued for it. The manufacturer submits a 09409_FLUKA CEP (COS) as part of the market authorization procedure, and it takes on the role of a 09409_FLUKA CEP holder for the record. Additionally, the data presented in the 09409_FLUKA CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 09409_FLUKA DMF.

A 09409_FLUKA CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 09409_FLUKA CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of 09409_FLUKA suppliers with CEP (COS) 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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