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Zhejiang Hengkang Mesalazine Zhejiang Hengkang Mesalazine

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List of Drug Master Files (KDMF) for Mesalazine Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 PharmaZell (India) Private Ltd (1)

02 PharmaZell (India) Private Ltd. (1)

03 PharmaZell GmbH (3)

04 Cambrex, Karlskoga AB (1)

05 Chemistry SpA (1)

06 Divi`s Laboratories Limited (1)

07 Syntese A/S (1)

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01 Daewoong Pharmaceutical Co., Ltd. (2)

02 Eltech Pharmachem Co., Ltd. (2)

03 Korea Ferring Pharmaceutical Co., Ltd. (1)

04 Pharmaline Co., Ltd. (1)

05 Samo Pharmaceutical Co., Ltd. (1)

06 Takeda Pharmaceutical Korea Co., Ltd. (2)

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01 Mesalazine (8)

02 mesalamine (1)

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01 Denmark (1)

02 Germany (5)

03 India (1)

04 Italy (1)

05 U.S.A (1)

Takeda Pharmaceutical Korea Co., Ltd.
2021-10-05
20210521-209-J-766(1)
PharmaZell (India) Privat...
India
Plot No. 115, Ramky Pharm...
Axplora CB

Iran Expo

Not Confirmed

envelop Contact Supplier
Eltech Pharmachem Co., Ltd.
2021-05-21
20210521-209-J-766
PharmaZell (India) Privat...
India
Plot No. 115, Ramky Pharm...
Axplora CB

Iran Expo

Not Confirmed

envelop Contact Supplier
Daewoong Pharmaceutical Co., Ltd.
2020-07-09
20200602-209-J-386(1)
PharmaZell GmbH
Germany
Rosenheimer Straße 43 83...
Axplora CB

Iran Expo

Not Confirmed

envelop Contact Supplier
Eltech Pharmachem Co., Ltd.
2020-06-02
20200602-209-J-386
PharmaZell GmbH
Germany
Rosenheimer Straße 43 83...
Axplora CB

Iran Expo

Not Confirmed

envelop Contact Supplier
Takeda Pharmaceutical Korea Co., Ltd.
2020-07-23
20200602-209-J-386(2)
PharmaZell GmbH
Germany
Rosenheimer Straße 43 83...
Axplora CB

Iran Expo

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
Daewoong Pharmaceutical Co., Ltd.
2020-06-25
20200625-209-J-403
Cambrex, Karlskoga AB
Sweden
Bjorkborn Industriomrade,...
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Samo Pharmaceutical Co., Ltd.
2023-05-09
20230509-209-J-1430
Chemistry SpA
Italy
Via Vadisi, 5-03010 Patri...
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Pharmaline Co., Ltd.
2020-07-21
20200721-211-J-697
Divi`s Laboratories Limit...
India
Chippada Village Annavara...
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Korea Ferring Pharmaceutical Co., Ltd.
2021-05-10
20210510-209-J-981
Syntese A/S
Denmark
Industriholmen 11-13, Hvi...
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Looking for 89-57-6 / Mesalazine API manufacturers, exporters & distributors?

Mesalazine manufacturers, exporters & distributors 1

42

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)

Mesalazine Manufacturers

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

Mesalazine Suppliers

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

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

Mesalazine KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Mesalazine Drug Master File in Korea (Mesalazine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mesalazine. The MFDS reviews the Mesalazine KDMF as part of the drug registration process and uses the information provided in the Mesalazine KDMF to evaluate the safety and efficacy of the drug.

After submitting a Mesalazine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Mesalazine API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Mesalazine suppliers with KDMF on PharmaCompass.

Mesalazine Manufacturers | Traders | Suppliers

Mesalazine Manufacturers, Traders, Suppliers 1
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We have 5 companies offering Mesalazine

Get in contact with the supplier of your choice:

  1. Axplora
  2. Cambrex Corporation
  3. Chemi SpA
  4. Divis Laboratories
  5. Syntese AS
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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