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