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API SUPPLIERS
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A N-Acetyltyrosine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-Acetyltyrosine, including repackagers and relabelers. The FDA regulates N-Acetyltyrosine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-Acetyltyrosine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A N-Acetyltyrosine supplier is an individual or a company that provides N-Acetyltyrosine active pharmaceutical ingredient (API) or N-Acetyltyrosine finished formulations upon request. The N-Acetyltyrosine suppliers may include N-Acetyltyrosine API manufacturers, exporters, distributors and traders.
click here to find a list of N-Acetyltyrosine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A N-Acetyltyrosine CEP of the European Pharmacopoeia monograph is often referred to as a N-Acetyltyrosine Certificate of Suitability (COS). The purpose of a N-Acetyltyrosine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of N-Acetyltyrosine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of N-Acetyltyrosine to their clients by showing that a N-Acetyltyrosine CEP has been issued for it. The manufacturer submits a N-Acetyltyrosine CEP (COS) as part of the market authorization procedure, and it takes on the role of a N-Acetyltyrosine CEP holder for the record. Additionally, the data presented in the N-Acetyltyrosine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the N-Acetyltyrosine DMF.
A N-Acetyltyrosine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. N-Acetyltyrosine 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 N-Acetyltyrosine 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 N-Acetyltyrosine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for N-Acetyltyrosine 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 N-Acetyltyrosine 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 N-Acetyltyrosine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a N-Acetyltyrosine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of N-Acetyltyrosine suppliers with NDC on PharmaCompass.
N-Acetyltyrosine 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 N-Acetyltyrosine 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 N-Acetyltyrosine GMP manufacturer or N-Acetyltyrosine GMP API supplier for your needs.
A N-Acetyltyrosine CoA (Certificate of Analysis) is a formal document that attests to N-Acetyltyrosine's compliance with N-Acetyltyrosine specifications and serves as a tool for batch-level quality control.
N-Acetyltyrosine CoA mostly includes findings from lab analyses of a specific batch. For each N-Acetyltyrosine 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.
N-Acetyltyrosine may be tested according to a variety of international standards, such as European Pharmacopoeia (N-Acetyltyrosine EP), N-Acetyltyrosine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (N-Acetyltyrosine USP).
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