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