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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 : 41012
Submission : 2024-12-31
Status :
Type : II
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ABOUT THIS PAGE
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PharmaCompass offers a list of Ruxolitinib Phosphate 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 Ruxolitinib Phosphate manufacturer or Ruxolitinib Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ruxolitinib Phosphate manufacturer or Ruxolitinib Phosphate supplier.
PharmaCompass also assists you with knowing the Ruxolitinib Phosphate API Price utilized in the formulation of products. Ruxolitinib Phosphate API Price is not always fixed or binding as the Ruxolitinib Phosphate Price is obtained through a variety of data sources. The Ruxolitinib Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Jakafi manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Jakafi, including repackagers and relabelers. The FDA regulates Jakafi manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Jakafi 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 Jakafi manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Jakafi supplier is an individual or a company that provides Jakafi active pharmaceutical ingredient (API) or Jakafi finished formulations upon request. The Jakafi suppliers may include Jakafi API manufacturers, exporters, distributors and traders.
click here to find a list of Jakafi suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Jakafi DMF (Drug Master File) is a document detailing the whole manufacturing process of Jakafi active pharmaceutical ingredient (API) in detail. Different forms of Jakafi DMFs exist exist since differing nations have different regulations, such as Jakafi USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Jakafi DMF submitted to regulatory agencies in the US is known as a USDMF. Jakafi USDMF includes data on Jakafi's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Jakafi USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Jakafi 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 Jakafi Drug Master File in Korea (Jakafi KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Jakafi. The MFDS reviews the Jakafi KDMF as part of the drug registration process and uses the information provided in the Jakafi KDMF to evaluate the safety and efficacy of the drug.
After submitting a Jakafi 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 Jakafi API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Jakafi suppliers with KDMF on PharmaCompass.
A Jakafi written confirmation (Jakafi WC) is an official document issued by a regulatory agency to a Jakafi manufacturer, verifying that the manufacturing facility of a Jakafi active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Jakafi APIs or Jakafi finished pharmaceutical products to another nation, regulatory agencies frequently require a Jakafi WC (written confirmation) as part of the regulatory process.
click here to find a list of Jakafi 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 Jakafi as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Jakafi 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 Jakafi 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 Jakafi and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Jakafi NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Jakafi suppliers with NDC on PharmaCompass.
Jakafi 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 Jakafi 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 Jakafi GMP manufacturer or Jakafi GMP API supplier for your needs.
A Jakafi CoA (Certificate of Analysis) is a formal document that attests to Jakafi's compliance with Jakafi specifications and serves as a tool for batch-level quality control.
Jakafi CoA mostly includes findings from lab analyses of a specific batch. For each Jakafi 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.
Jakafi may be tested according to a variety of international standards, such as European Pharmacopoeia (Jakafi EP), Jakafi JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Jakafi USP).
