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