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