Synopsis
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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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
About the Company : Inabata France, established in 1990 and part of the Inabata Group, acquired Pharmasynthèse in 2006. Today, Inabata-Pharmasynthèse offers sourcing, manufacturing, and development ...
China’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM services and Finished ...
Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.
About the Company : Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Derivatives (Caffeine, e...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
About the Company : Tagoor Laboratories, established in 2018 and part of the Tagoor Group, provides APIs, advanced intermediates, and key starting materials for critical and high-growth therapeutic ar...
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers cost-effective APIs with speed, supported by a skilled team. As the first Southeast Asian company to receive FDA approv...
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
About the Company : Sichuan Qingmu Pharmaceutical is an innovation-driven company specializing in generic APIs, advanced intermediates, and CDMO/CMO services for small-molecule drugs. Approved by US F...
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
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NanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.
Regulatory Info :
Registration Country : Iran
Brand Name : Relata
Dosage Form : Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
NanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.
Regulatory Info :
Registration Country : Iran
Brand Name : Relata
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
NanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.
Regulatory Info :
Registration Country : Iran
Brand Name : Relata
Dosage Form : Tablet
Dosage Strength : 15MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
NanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.
Regulatory Info :
Registration Country : Iran
Brand Name : Relata
Dosage Form : Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
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
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : USP-NF,BP,EP,IP
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Capsule
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF,BP,EP,IP
Technical Specs : NA
Ingredient(s) : Microcrystalline Cellulose Excipients
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.
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
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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]Fillers, Diluents & Binders
Granulation
Direct Compression
Disintegrants & Superdisintegrants
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Co-Processed Excipients
Solubilizers
Controlled & Modified Release
Emulsifying Agents
Chewable & Orodispersible Aids
Coating Systems & Additives
Parenteral
Film Formers & Plasticizers
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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 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, and COA 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, and COA 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, 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).
