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JDMF
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KDMF
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VMF
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Data Compilation #PharmaFlow
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42887
Submission : 2025-10-31
Status :
Type : II
Maithri Drugs: Dedicated to your API needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39774
Submission : 2024-03-31
Status :
Type : II
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Maithri Drugs: Dedicated to your API needs.
Date of Issue : 2024-02-12
Valid Till : 2027-02-11
Written Confirmation Number : WC-0407
Address of the Firm : Sy. No. 205, 222 to 226, IDA Bonthapally, Bonthapally (Village), Gummadidala (Ma...
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Nuray Chemicals Pvt Ltd, established in 2012 near Chennai, is an API manufacturer for highly regulated markets. Its state-of-the-art R&D facility specializes in synthesizing NCEs, ...
Maithri Drugs: Dedicated to your API needs.
About the Company : Maithri Drugs Pvt. Ltd. is a global supplier of Active Pharmaceutical Ingredients (APIs), serving pharmaceutical companies in 60+ countries. Its API portfolio spans antivirals, ant...
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PharmaCompass offers a list of Mitapivat API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Mitapivat manufacturer or Mitapivat supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mitapivat manufacturer or Mitapivat supplier.
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, and COA 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, and COA 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.
A Mitapivat written confirmation (Mitapivat WC) is an official document issued by a regulatory agency to a Mitapivat manufacturer, verifying that the manufacturing facility of a Mitapivat active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mitapivat APIs or Mitapivat finished pharmaceutical products to another nation, regulatory agencies frequently require a Mitapivat WC (written confirmation) as part of the regulatory process.
click here to find a list of Mitapivat suppliers with Written Confirmation (WC) 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 Mitapivat as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mitapivat 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 Mitapivat 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 Mitapivat and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mitapivat NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mitapivat suppliers with NDC 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, 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).
