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