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