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