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19
PharmaCompass offers a list of L-Histidine 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-Histidine manufacturer or L-Histidine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred L-Histidine manufacturer or L-Histidine supplier.
PharmaCompass also assists you with knowing the L-Histidine API Price utilized in the formulation of products. L-Histidine API Price is not always fixed or binding as the L-Histidine Price is obtained through a variety of data sources. The L-Histidine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A (2S)-2-amino-3-(imidazol-4-yl)propanoic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (2S)-2-amino-3-(imidazol-4-yl)propanoic acid, including repackagers and relabelers. The FDA regulates (2S)-2-amino-3-(imidazol-4-yl)propanoic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (2S)-2-amino-3-(imidazol-4-yl)propanoic acid 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 (2S)-2-amino-3-(imidazol-4-yl)propanoic acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (2S)-2-amino-3-(imidazol-4-yl)propanoic acid supplier is an individual or a company that provides (2S)-2-amino-3-(imidazol-4-yl)propanoic acid active pharmaceutical ingredient (API) or (2S)-2-amino-3-(imidazol-4-yl)propanoic acid finished formulations upon request. The (2S)-2-amino-3-(imidazol-4-yl)propanoic acid suppliers may include (2S)-2-amino-3-(imidazol-4-yl)propanoic acid API manufacturers, exporters, distributors and traders.
click here to find a list of (2S)-2-amino-3-(imidazol-4-yl)propanoic acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A (2S)-2-amino-3-(imidazol-4-yl)propanoic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of (2S)-2-amino-3-(imidazol-4-yl)propanoic acid active pharmaceutical ingredient (API) in detail. Different forms of (2S)-2-amino-3-(imidazol-4-yl)propanoic acid DMFs exist exist since differing nations have different regulations, such as (2S)-2-amino-3-(imidazol-4-yl)propanoic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (2S)-2-amino-3-(imidazol-4-yl)propanoic acid DMF submitted to regulatory agencies in the US is known as a USDMF. (2S)-2-amino-3-(imidazol-4-yl)propanoic acid USDMF includes data on (2S)-2-amino-3-(imidazol-4-yl)propanoic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (2S)-2-amino-3-(imidazol-4-yl)propanoic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 (2S)-2-amino-3-(imidazol-4-yl)propanoic acid Drug Master File in Japan ((2S)-2-amino-3-(imidazol-4-yl)propanoic acid JDMF) empowers (2S)-2-amino-3-(imidazol-4-yl)propanoic acid 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 (2S)-2-amino-3-(imidazol-4-yl)propanoic acid JDMF during the approval evaluation for pharmaceutical products. At the time of (2S)-2-amino-3-(imidazol-4-yl)propanoic acid JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A (2S)-2-amino-3-(imidazol-4-yl)propanoic acid CEP of the European Pharmacopoeia monograph is often referred to as a (2S)-2-amino-3-(imidazol-4-yl)propanoic acid Certificate of Suitability (COS). The purpose of a (2S)-2-amino-3-(imidazol-4-yl)propanoic acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of (2S)-2-amino-3-(imidazol-4-yl)propanoic acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of (2S)-2-amino-3-(imidazol-4-yl)propanoic acid to their clients by showing that a (2S)-2-amino-3-(imidazol-4-yl)propanoic acid CEP has been issued for it. The manufacturer submits a (2S)-2-amino-3-(imidazol-4-yl)propanoic acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a (2S)-2-amino-3-(imidazol-4-yl)propanoic acid CEP holder for the record. Additionally, the data presented in the (2S)-2-amino-3-(imidazol-4-yl)propanoic acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the (2S)-2-amino-3-(imidazol-4-yl)propanoic acid DMF.
A (2S)-2-amino-3-(imidazol-4-yl)propanoic acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. (2S)-2-amino-3-(imidazol-4-yl)propanoic acid 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 (2S)-2-amino-3-(imidazol-4-yl)propanoic acid 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 (2S)-2-amino-3-(imidazol-4-yl)propanoic acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for (2S)-2-amino-3-(imidazol-4-yl)propanoic acid 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 (2S)-2-amino-3-(imidazol-4-yl)propanoic acid 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 (2S)-2-amino-3-(imidazol-4-yl)propanoic acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a (2S)-2-amino-3-(imidazol-4-yl)propanoic acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of (2S)-2-amino-3-(imidazol-4-yl)propanoic acid suppliers with NDC on PharmaCompass.
(2S)-2-amino-3-(imidazol-4-yl)propanoic acid 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 (2S)-2-amino-3-(imidazol-4-yl)propanoic acid 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 (2S)-2-amino-3-(imidazol-4-yl)propanoic acid GMP manufacturer or (2S)-2-amino-3-(imidazol-4-yl)propanoic acid GMP API supplier for your needs.
A (2S)-2-amino-3-(imidazol-4-yl)propanoic acid CoA (Certificate of Analysis) is a formal document that attests to (2S)-2-amino-3-(imidazol-4-yl)propanoic acid's compliance with (2S)-2-amino-3-(imidazol-4-yl)propanoic acid specifications and serves as a tool for batch-level quality control.
(2S)-2-amino-3-(imidazol-4-yl)propanoic acid CoA mostly includes findings from lab analyses of a specific batch. For each (2S)-2-amino-3-(imidazol-4-yl)propanoic acid 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.
(2S)-2-amino-3-(imidazol-4-yl)propanoic acid may be tested according to a variety of international standards, such as European Pharmacopoeia ((2S)-2-amino-3-(imidazol-4-yl)propanoic acid EP), (2S)-2-amino-3-(imidazol-4-yl)propanoic acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia ((2S)-2-amino-3-(imidazol-4-yl)propanoic acid USP).
