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ABOUT THIS PAGE
93
PharmaCompass offers a list of Methionine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Methionine manufacturer or Methionine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methionine manufacturer or Methionine supplier.
A Methionine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methionine, including repackagers and relabelers. The FDA regulates Methionine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methionine 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 Methionine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Methionine supplier is an individual or a company that provides Methionine active pharmaceutical ingredient (API) or Methionine finished formulations upon request. The Methionine suppliers may include Methionine API manufacturers, exporters, distributors and traders.
click here to find a list of Methionine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Methionine DMF (Drug Master File) is a document detailing the whole manufacturing process of Methionine active pharmaceutical ingredient (API) in detail. Different forms of Methionine DMFs exist exist since differing nations have different regulations, such as Methionine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methionine DMF submitted to regulatory agencies in the US is known as a USDMF. Methionine USDMF includes data on Methionine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methionine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methionine suppliers with USDMF on PharmaCompass.
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 Methionine Drug Master File in Japan (Methionine JDMF) empowers Methionine 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 Methionine JDMF during the approval evaluation for pharmaceutical products. At the time of Methionine 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 Methionine suppliers with JDMF on PharmaCompass.
A Methionine CEP of the European Pharmacopoeia monograph is often referred to as a Methionine Certificate of Suitability (COS). The purpose of a Methionine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Methionine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Methionine to their clients by showing that a Methionine CEP has been issued for it. The manufacturer submits a Methionine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Methionine CEP holder for the record. Additionally, the data presented in the Methionine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Methionine DMF.
A Methionine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Methionine 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 Methionine suppliers with CEP (COS) on PharmaCompass.
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 Methionine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Methionine API and other APIs are published in this directory by the FDA.
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 Methionine 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.
The NDC directory also contains data on finished compounded human drug products that contain Methionine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Methionine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Methionine suppliers with NDC on PharmaCompass.
Methionine 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 Methionine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Methionine GMP manufacturer or Methionine GMP API supplier for your needs.
A Methionine CoA (Certificate of Analysis) is a formal document that attests to Methionine's compliance with Methionine specifications and serves as a tool for batch-level quality control.
Methionine CoA mostly includes findings from lab analyses of a specific batch. For each Methionine 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.
Methionine may be tested according to a variety of international standards, such as European Pharmacopoeia (Methionine EP), Methionine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Methionine USP).
