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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
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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, 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.
A Jakavi manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Jakavi, including repackagers and relabelers. The FDA regulates Jakavi manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Jakavi 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 Jakavi manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Jakavi supplier is an individual or a company that provides Jakavi active pharmaceutical ingredient (API) or Jakavi finished formulations upon request. The Jakavi suppliers may include Jakavi API manufacturers, exporters, distributors and traders.
click here to find a list of Jakavi suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Jakavi DMF (Drug Master File) is a document detailing the whole manufacturing process of Jakavi active pharmaceutical ingredient (API) in detail. Different forms of Jakavi DMFs exist exist since differing nations have different regulations, such as Jakavi USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Jakavi DMF submitted to regulatory agencies in the US is known as a USDMF. Jakavi USDMF includes data on Jakavi's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Jakavi USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Jakavi 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 Jakavi Drug Master File in Korea (Jakavi KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Jakavi. The MFDS reviews the Jakavi KDMF as part of the drug registration process and uses the information provided in the Jakavi KDMF to evaluate the safety and efficacy of the drug.
After submitting a Jakavi 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 Jakavi API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Jakavi suppliers with KDMF on PharmaCompass.
A Jakavi written confirmation (Jakavi WC) is an official document issued by a regulatory agency to a Jakavi manufacturer, verifying that the manufacturing facility of a Jakavi active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Jakavi APIs or Jakavi finished pharmaceutical products to another nation, regulatory agencies frequently require a Jakavi WC (written confirmation) as part of the regulatory process.
click here to find a list of Jakavi 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 Jakavi as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Jakavi 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 Jakavi 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 Jakavi and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Jakavi NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Jakavi suppliers with NDC on PharmaCompass.
Jakavi 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 Jakavi GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Jakavi GMP manufacturer or Jakavi GMP API supplier for your needs.
A Jakavi CoA (Certificate of Analysis) is a formal document that attests to Jakavi's compliance with Jakavi specifications and serves as a tool for batch-level quality control.
Jakavi CoA mostly includes findings from lab analyses of a specific batch. For each Jakavi 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.
Jakavi may be tested according to a variety of international standards, such as European Pharmacopoeia (Jakavi EP), Jakavi JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Jakavi USP).
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