X
API Suppliers
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
90
PharmaCompass offers a list of Trofinetide 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 Trofinetide manufacturer or Trofinetide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Trofinetide manufacturer or Trofinetide supplier.
PharmaCompass also assists you with knowing the Trofinetide API Price utilized in the formulation of products. Trofinetide API Price is not always fixed or binding as the Trofinetide Price is obtained through a variety of data sources. The Trofinetide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Trofinetide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trofinetide, including repackagers and relabelers. The FDA regulates Trofinetide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trofinetide 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 Trofinetide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trofinetide supplier is an individual or a company that provides Trofinetide active pharmaceutical ingredient (API) or Trofinetide finished formulations upon request. The Trofinetide suppliers may include Trofinetide API manufacturers, exporters, distributors and traders.
click here to find a list of Trofinetide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Trofinetide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trofinetide 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 Trofinetide 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 Trofinetide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trofinetide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trofinetide suppliers with NDC on PharmaCompass.
Trofinetide 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 Trofinetide 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 Trofinetide GMP manufacturer or Trofinetide GMP API supplier for your needs.
A Trofinetide CoA (Certificate of Analysis) is a formal document that attests to Trofinetide's compliance with Trofinetide specifications and serves as a tool for batch-level quality control.
Trofinetide CoA mostly includes findings from lab analyses of a specific batch. For each Trofinetide 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.
Trofinetide may be tested according to a variety of international standards, such as European Pharmacopoeia (Trofinetide EP), Trofinetide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trofinetide USP).
Market Place
