Synopsis
0
CEP/COS
0
JDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
DRUG PRODUCT COMPOSITIONS
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
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.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
Date of Issue : 2025-08-22
Valid Till : 2028-08-21
Written Confirmation Number : WC-0099
Address of the Firm : Plot No.E-50, 50/1 and 59/1, Unit-IV, MIDC, Tarapur-401506, Taluka: Palghar, Dis...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2026-02-20
Registration Number : Su258-55-ND
Manufacturer Name : Shandong Chenghui Shuangda P...
Manufacturer Address : Economic Development Zone, Pingyuan County, Dezhou City, Shandong, PRChina
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dr. Paul Lohmann GmbH & Co. KGaA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Neelkanth MineChem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Granulation
Direct Compression
Disintegrants & Superdisintegrants
Thickeners and Stabilizers
Lubricants & Glidants
Co-Processed Excipients
Solubilizers
Controlled & Modified Release
Emulsifying Agents
Chewable & Orodispersible Aids
Coating Systems & Additives
Parenteral
Film Formers & Plasticizers
Taste Masking
API Stability Enhancers
Rheology Modifiers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
ABOUT THIS PAGE
98
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 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, and COA 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, and COA 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, 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).
