Synopsis
0
USDMF
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
Listed Suppliers
0
EDQM
0
USP
0
JP
0
Others
0
FDF Dossiers
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
US Medicaid
NA
Annual Reports
NA
Regulatory FDF Prices
NA
0
API
0
FDF
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
ABOUT THIS PAGE
77
PharmaCompass offers a list of Aficamten 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 Aficamten manufacturer or Aficamten supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aficamten manufacturer or Aficamten supplier.
PharmaCompass also assists you with knowing the Aficamten API Price utilized in the formulation of products. Aficamten API Price is not always fixed or binding as the Aficamten Price is obtained through a variety of data sources. The Aficamten Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Aficamten manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aficamten, including repackagers and relabelers. The FDA regulates Aficamten manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aficamten 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 Aficamten supplier is an individual or a company that provides Aficamten active pharmaceutical ingredient (API) or Aficamten finished formulations upon request. The Aficamten suppliers may include Aficamten API manufacturers, exporters, distributors and traders.
click here to find a list of Aficamten 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 Aficamten as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aficamten 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 Aficamten 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 Aficamten and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aficamten NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aficamten suppliers with NDC on PharmaCompass.
Aficamten 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 Aficamten 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 Aficamten GMP manufacturer or Aficamten GMP API supplier for your needs.
A Aficamten CoA (Certificate of Analysis) is a formal document that attests to Aficamten's compliance with Aficamten specifications and serves as a tool for batch-level quality control.
Aficamten CoA mostly includes findings from lab analyses of a specific batch. For each Aficamten 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.
Aficamten may be tested according to a variety of international standards, such as European Pharmacopoeia (Aficamten EP), Aficamten JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aficamten USP).
