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