Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
API
0
FDF
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
A Mitapivat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mitapivat, including repackagers and relabelers. The FDA regulates Mitapivat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mitapivat 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 Mitapivat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mitapivat supplier is an individual or a company that provides Mitapivat active pharmaceutical ingredient (API) or Mitapivat finished formulations upon request. The Mitapivat suppliers may include Mitapivat API manufacturers, exporters, distributors and traders.
click here to find a list of Mitapivat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mitapivat DMF (Drug Master File) is a document detailing the whole manufacturing process of Mitapivat active pharmaceutical ingredient (API) in detail. Different forms of Mitapivat DMFs exist exist since differing nations have different regulations, such as Mitapivat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mitapivat DMF submitted to regulatory agencies in the US is known as a USDMF. Mitapivat USDMF includes data on Mitapivat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mitapivat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mitapivat suppliers with USDMF on PharmaCompass.
Mitapivat 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 Mitapivat 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 Mitapivat GMP manufacturer or Mitapivat GMP API supplier for your needs.
A Mitapivat CoA (Certificate of Analysis) is a formal document that attests to Mitapivat's compliance with Mitapivat specifications and serves as a tool for batch-level quality control.
Mitapivat CoA mostly includes findings from lab analyses of a specific batch. For each Mitapivat 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.
Mitapivat may be tested according to a variety of international standards, such as European Pharmacopoeia (Mitapivat EP), Mitapivat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mitapivat USP).
LOOKING FOR A SUPPLIER?
