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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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Navitoclax,Ruxolitinib Phosphate
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 10, 2022
Lead Product(s) : Navitoclax,Ruxolitinib Phosphate
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 12, 2022
Lead Product(s) : Navitoclax,Ruxolitinib Phosphate
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Navitoclax is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Primary Myelofibrosis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 15, 2020
Lead Product(s) : Navitoclax,Ruxolitinib Phosphate
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Navitoclax is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Primary Myelofibrosis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 13, 2020
Lead Product(s) : Ruxolitinib Phosphate,Venetoclax
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Brian Druker
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ruxolitinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Leukemia, Myeloid, Acute.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 14, 2019
Lead Product(s) : Ruxolitinib Phosphate,Navitoclax
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ruxolitinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Primary Myelofibrosis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 19, 2017
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
1-(1-ethoxyethyl)-4-(4,4,5,5- tetramethyl-1,3,2-di...
CAS Number : 1029716-44-6
End Use API : Ruxolitinib Phosphate
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM se...
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
CAS Number : 591769-05-0
End Use API : Ruxolitinib Phosphate
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM se...
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
(4-(1-(2-Cyano-1- cyclopentylethyl)-1h-pyrazol-4-y...
CAS Number : 1236033-05-8
End Use API : Ruxolitinib Phosphate
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM se...
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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 Ruxolitinib Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ruxolitinib Phosphate, including repackagers and relabelers. The FDA regulates Ruxolitinib Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ruxolitinib Phosphate 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 Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ruxolitinib Phosphate supplier is an individual or a company that provides Ruxolitinib Phosphate active pharmaceutical ingredient (API) or Ruxolitinib Phosphate finished formulations upon request. The Ruxolitinib Phosphate suppliers may include Ruxolitinib Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Ruxolitinib Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ruxolitinib Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ruxolitinib Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Ruxolitinib Phosphate DMFs exist exist since differing nations have different regulations, such as Ruxolitinib Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ruxolitinib Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Ruxolitinib Phosphate USDMF includes data on Ruxolitinib Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ruxolitinib Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ruxolitinib Phosphate 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 Phosphate Drug Master File in Korea (Ruxolitinib Phosphate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ruxolitinib Phosphate. The MFDS reviews the Ruxolitinib Phosphate KDMF as part of the drug registration process and uses the information provided in the Ruxolitinib Phosphate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ruxolitinib Phosphate 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 Phosphate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ruxolitinib Phosphate suppliers with KDMF on PharmaCompass.
A Ruxolitinib Phosphate written confirmation (Ruxolitinib Phosphate WC) is an official document issued by a regulatory agency to a Ruxolitinib Phosphate manufacturer, verifying that the manufacturing facility of a Ruxolitinib Phosphate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ruxolitinib Phosphate APIs or Ruxolitinib Phosphate finished pharmaceutical products to another nation, regulatory agencies frequently require a Ruxolitinib Phosphate WC (written confirmation) as part of the regulatory process.
click here to find a list of Ruxolitinib Phosphate 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 Phosphate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ruxolitinib Phosphate 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 Phosphate 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 Phosphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ruxolitinib Phosphate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ruxolitinib Phosphate suppliers with NDC on PharmaCompass.
Ruxolitinib Phosphate 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 Phosphate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ruxolitinib Phosphate GMP manufacturer or Ruxolitinib Phosphate GMP API supplier for your needs.
A Ruxolitinib Phosphate CoA (Certificate of Analysis) is a formal document that attests to Ruxolitinib Phosphate's compliance with Ruxolitinib Phosphate specifications and serves as a tool for batch-level quality control.
Ruxolitinib Phosphate CoA mostly includes findings from lab analyses of a specific batch. For each Ruxolitinib Phosphate 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 Phosphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Ruxolitinib Phosphate EP), Ruxolitinib Phosphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ruxolitinib Phosphate USP).
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