Synopsis
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CEP/COS
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JDMF
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EU WC
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VMF
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EDQM
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USP
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JP
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Others
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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FDF
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Weekly News Recap #Phispers
API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Fareva: One stop for innovative drug development, precision manufacturing and high-quality APIs.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2025-06-20
Pay. Date : 2025-05-29
DMF Number : 41014
Submission : 2024-12-31
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2025-06-25
Pay. Date : 2025-05-29
DMF Number : 41393
Submission : 2025-02-28
Status :
Type : II
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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&...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
Fareva: One stop for innovative drug development, precision manufacturing and high-quality APIs.
About the Company : Founded in 1990 in France, Fareva is a global subcontractor providing R&D, production, and packaging services across pharmaceutical, cosmetics, and industrial sectors. Operating in...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Asciminib 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 Asciminib manufacturer or Asciminib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Asciminib manufacturer or Asciminib supplier.
A Asciminib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Asciminib, including repackagers and relabelers. The FDA regulates Asciminib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Asciminib 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 Asciminib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Asciminib supplier is an individual or a company that provides Asciminib active pharmaceutical ingredient (API) or Asciminib finished formulations upon request. The Asciminib suppliers may include Asciminib API manufacturers, exporters, distributors and traders.
click here to find a list of Asciminib suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Asciminib DMF (Drug Master File) is a document detailing the whole manufacturing process of Asciminib active pharmaceutical ingredient (API) in detail. Different forms of Asciminib DMFs exist exist since differing nations have different regulations, such as Asciminib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Asciminib DMF submitted to regulatory agencies in the US is known as a USDMF. Asciminib USDMF includes data on Asciminib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Asciminib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Asciminib suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Asciminib Drug Master File in Korea (Asciminib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Asciminib. The MFDS reviews the Asciminib KDMF as part of the drug registration process and uses the information provided in the Asciminib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Asciminib KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Asciminib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Asciminib suppliers with KDMF 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 Asciminib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Asciminib 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 Asciminib 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 Asciminib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Asciminib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Asciminib suppliers with NDC on PharmaCompass.
Asciminib 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 Asciminib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Asciminib GMP manufacturer or Asciminib GMP API supplier for your needs.
A Asciminib CoA (Certificate of Analysis) is a formal document that attests to Asciminib's compliance with Asciminib specifications and serves as a tool for batch-level quality control.
Asciminib CoA mostly includes findings from lab analyses of a specific batch. For each Asciminib 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.
Asciminib may be tested according to a variety of international standards, such as European Pharmacopoeia (Asciminib EP), Asciminib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Asciminib USP).
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