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API SUPPLIERS
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
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.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
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USDMF
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Drugs in Development
Lead Product(s) : Navitoclax,Ruxolitinib Phosphate
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
AbbVie Presents Investigational Navitoclax Preliminary Data in JAK Inhibitor Naïve Myelofibrosis ...
Details : Results are from an exploratory analysis of ABT-263 (navitoclax) plus ruxolitinib from Cohort 3 of the Phase 2 REFINE study in JAK inhibitor naïve myelofibrosis patients.
Brand Name : ABT-263
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 10, 2022
Lead Product(s) : Navitoclax,Ruxolitinib Phosphate
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Navitoclax is an investigational, oral BCL-XL/BCL-2 inhibitor. The BCL-2 family of proteins are known regulators of the apoptosis pathway. Its safety and efficacy are under evaluation as part of ongoing Phase 2 and registrational Phase 3 studies.
Brand Name : ABT-263
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 12, 2022
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SPI Pharma
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
A Ruxolitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ruxolitinib, including repackagers and relabelers. The FDA regulates Ruxolitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ruxolitinib 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 Ruxolitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ruxolitinib supplier is an individual or a company that provides Ruxolitinib active pharmaceutical ingredient (API) or Ruxolitinib finished formulations upon request. The Ruxolitinib suppliers may include Ruxolitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Ruxolitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ruxolitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Ruxolitinib active pharmaceutical ingredient (API) in detail. Different forms of Ruxolitinib DMFs exist exist since differing nations have different regulations, such as Ruxolitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ruxolitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Ruxolitinib USDMF includes data on Ruxolitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ruxolitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ruxolitinib 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 Ruxolitinib Drug Master File in Korea (Ruxolitinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ruxolitinib. The MFDS reviews the Ruxolitinib KDMF as part of the drug registration process and uses the information provided in the Ruxolitinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ruxolitinib 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 Ruxolitinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ruxolitinib suppliers with KDMF on PharmaCompass.
A Ruxolitinib written confirmation (Ruxolitinib WC) is an official document issued by a regulatory agency to a Ruxolitinib manufacturer, verifying that the manufacturing facility of a Ruxolitinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ruxolitinib APIs or Ruxolitinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Ruxolitinib WC (written confirmation) as part of the regulatory process.
click here to find a list of Ruxolitinib 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 Ruxolitinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ruxolitinib 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 Ruxolitinib 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 Ruxolitinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ruxolitinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ruxolitinib suppliers with NDC on PharmaCompass.
Ruxolitinib 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 Ruxolitinib 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 Ruxolitinib GMP manufacturer or Ruxolitinib GMP API supplier for your needs.
A Ruxolitinib CoA (Certificate of Analysis) is a formal document that attests to Ruxolitinib's compliance with Ruxolitinib specifications and serves as a tool for batch-level quality control.
Ruxolitinib CoA mostly includes findings from lab analyses of a specific batch. For each Ruxolitinib 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.
Ruxolitinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Ruxolitinib EP), Ruxolitinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ruxolitinib USP).
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