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PharmaCompass

01

BioAsia
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAxplora- The partner of choice for complex APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2014-12-16

Pay. Date : 2014-11-28

DMF Number : 8070

Submission : 1989-05-09

Status : Active

Type : II

Axplora CB

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothZhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.

GDUFA

DMF Review : Complete

Rev. Date : 2022-10-20

Pay. Date : 2022-09-16

DMF Number : 37319

Submission : 2022-08-17

Status : Active

Type : II

Zhejiang Hengkang Pharmaceutical

03

BioAsia
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 38338

Submission : 2023-10-14

Status : Active

Type : II

IOL Chemicals

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 11280

Submission : 1995-01-04

Status : Inactive

Type : II

TAPI Company Banner

07

BioAsia
Not Confirmed

08

BioAsia
Not Confirmed

09

BioAsia
Not Confirmed

10

BioAsia
Not Confirmed

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 USDMF

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

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

click here to find a list of Mesalazine 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.