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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 : 42348
Submission : 2025-07-31
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&...
With Fermion, start the journey of your innovative API.
About the Company : Fermion, a wholly owned subsidiary of Orion Corporation and headquartered in Espoo, Finland, is a fully integrated CDMO offering API and formulation services. Its API portfolio inc...
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PharmaCompass offers a list of Rucaparib Camsylate 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 Rucaparib Camsylate manufacturer or Rucaparib Camsylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rucaparib Camsylate manufacturer or Rucaparib Camsylate supplier.
A Rucaparib Camsylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rucaparib Camsylate, including repackagers and relabelers. The FDA regulates Rucaparib Camsylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rucaparib Camsylate 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 Rucaparib Camsylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Rucaparib Camsylate supplier is an individual or a company that provides Rucaparib Camsylate active pharmaceutical ingredient (API) or Rucaparib Camsylate finished formulations upon request. The Rucaparib Camsylate suppliers may include Rucaparib Camsylate API manufacturers, exporters, distributors and traders.
click here to find a list of Rucaparib Camsylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Rucaparib Camsylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Rucaparib Camsylate active pharmaceutical ingredient (API) in detail. Different forms of Rucaparib Camsylate DMFs exist exist since differing nations have different regulations, such as Rucaparib Camsylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rucaparib Camsylate DMF submitted to regulatory agencies in the US is known as a USDMF. Rucaparib Camsylate USDMF includes data on Rucaparib Camsylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rucaparib Camsylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rucaparib Camsylate suppliers with USDMF on PharmaCompass.
A Rucaparib Camsylate written confirmation (Rucaparib Camsylate WC) is an official document issued by a regulatory agency to a Rucaparib Camsylate manufacturer, verifying that the manufacturing facility of a Rucaparib Camsylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rucaparib Camsylate APIs or Rucaparib Camsylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Rucaparib Camsylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Rucaparib Camsylate 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 Rucaparib Camsylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rucaparib Camsylate 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 Rucaparib Camsylate 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 Rucaparib Camsylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rucaparib Camsylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rucaparib Camsylate suppliers with NDC on PharmaCompass.
Rucaparib Camsylate 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 Rucaparib Camsylate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Rucaparib Camsylate GMP manufacturer or Rucaparib Camsylate GMP API supplier for your needs.
A Rucaparib Camsylate CoA (Certificate of Analysis) is a formal document that attests to Rucaparib Camsylate's compliance with Rucaparib Camsylate specifications and serves as a tool for batch-level quality control.
Rucaparib Camsylate CoA mostly includes findings from lab analyses of a specific batch. For each Rucaparib Camsylate 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.
Rucaparib Camsylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Rucaparib Camsylate EP), Rucaparib Camsylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rucaparib Camsylate USP).
