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EU WC
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KDMF
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VMF
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Europe
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Listed Dossiers
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
US Medicaid
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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Kewpie Corporation
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Emulsifying Agents
Film Formers & Plasticizers
Coating Systems & Additives
Solubilizers
Topical
Controlled & Modified Release
Digital Content
NEWS #PharmaBuzz
Market Place
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
A L-Alanine API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-Alanine API, including repackagers and relabelers. The FDA regulates L-Alanine API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-Alanine API 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 L-Alanine API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-Alanine API supplier is an individual or a company that provides L-Alanine API active pharmaceutical ingredient (API) or L-Alanine API finished formulations upon request. The L-Alanine API suppliers may include L-Alanine API API manufacturers, exporters, distributors and traders.
click here to find a list of L-Alanine API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-Alanine API DMF (Drug Master File) is a document detailing the whole manufacturing process of L-Alanine API active pharmaceutical ingredient (API) in detail. Different forms of L-Alanine API DMFs exist exist since differing nations have different regulations, such as L-Alanine API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-Alanine API DMF submitted to regulatory agencies in the US is known as a USDMF. L-Alanine API USDMF includes data on L-Alanine API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-Alanine API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-Alanine API 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 L-Alanine API Drug Master File in Japan (L-Alanine API JDMF) empowers L-Alanine API 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 L-Alanine API JDMF during the approval evaluation for pharmaceutical products. At the time of L-Alanine API 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 L-Alanine API suppliers with JDMF on PharmaCompass.
A L-Alanine API CEP of the European Pharmacopoeia monograph is often referred to as a L-Alanine API Certificate of Suitability (COS). The purpose of a L-Alanine API CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of L-Alanine API EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of L-Alanine API to their clients by showing that a L-Alanine API CEP has been issued for it. The manufacturer submits a L-Alanine API CEP (COS) as part of the market authorization procedure, and it takes on the role of a L-Alanine API CEP holder for the record. Additionally, the data presented in the L-Alanine API CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the L-Alanine API DMF.
A L-Alanine API CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. L-Alanine API 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 L-Alanine API 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 L-Alanine API as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for L-Alanine API 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 L-Alanine API 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 L-Alanine API and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a L-Alanine API NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of L-Alanine API suppliers with NDC on PharmaCompass.
L-Alanine API 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 L-Alanine API 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 L-Alanine API GMP manufacturer or L-Alanine API GMP API supplier for your needs.
A L-Alanine API CoA (Certificate of Analysis) is a formal document that attests to L-Alanine API's compliance with L-Alanine API specifications and serves as a tool for batch-level quality control.
L-Alanine API CoA mostly includes findings from lab analyses of a specific batch. For each L-Alanine API 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.
L-Alanine API may be tested according to a variety of international standards, such as European Pharmacopoeia (L-Alanine API EP), L-Alanine API JP (Japanese Pharmacopeia) and the US Pharmacopoeia (L-Alanine API USP).
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