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Zhejiang Hengkang Mesalazine Zhejiang Hengkang Mesalazine

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  • ENEMA;RECTAL - 4GM/60ML
  • CAPSULE, EXTENDED RELEASE;ORAL - 250MG
  • CAPSULE, EXTENDED RELEASE;ORAL - 500MG
  • CAPSULE, DELAYED RELEASE;ORAL - 400MG
  • SUPPOSITORY;RECTAL - 1GM
  • TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, DELAYED RELEASE;ORAL - 1.2GM
  • CAPSULE, EXTENDED RELEASE;ORAL - 375MG

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)

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.

Mesalazine 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 Mesalazine Drug Master File in Japan (Mesalazine JDMF) empowers Mesalazine 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 Mesalazine JDMF during the approval evaluation for pharmaceutical products. At the time of Mesalazine 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 Mesalazine suppliers with JDMF 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 CEP

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

A Mesalazine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mesalazine 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 Mesalazine suppliers with CEP (COS) on PharmaCompass.

Mesalazine WC

A Mesalazine written confirmation (Mesalazine WC) is an official document issued by a regulatory agency to a Mesalazine manufacturer, verifying that the manufacturing facility of a Mesalazine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mesalazine APIs or Mesalazine finished pharmaceutical products to another nation, regulatory agencies frequently require a Mesalazine WC (written confirmation) as part of the regulatory process.

click here to find a list of Mesalazine suppliers with Written Confirmation (WC) on PharmaCompass.

Mesalazine NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Mesalazine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Mesalazine API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Mesalazine as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Mesalazine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mesalazine NDC to their finished compounded human drug products, they may choose to do so.

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

Mesalazine GMP

Mesalazine Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

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

Mesalazine CoA

A Mesalazine CoA (Certificate of Analysis) is a formal document that attests to Mesalazine's compliance with Mesalazine specifications and serves as a tool for batch-level quality control.

Mesalazine CoA mostly includes findings from lab analyses of a specific batch. For each Mesalazine CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Mesalazine may be tested according to a variety of international standards, such as European Pharmacopoeia (Mesalazine EP), Mesalazine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mesalazine USP).

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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