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