Synopsis
0
CEP/COS
0
VMF
0
EDQM
0
USP
0
JP
0
Others
DRUG PRODUCT COMPOSITIONS
0
Weekly News Recap #Phispers
API SUPPLIERS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-06
Pay. Date : 2016-05-04
DMF Number : 30402
Submission : 2016-03-29
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2024-09-19
Pay. Date : 2024-08-27
DMF Number : 32406
Submission : 2017-12-30
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-25
Pay. Date : 2015-12-21
DMF Number : 30124
Submission : 2016-01-21
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registration Number : 307MF10126
Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA
Initial Date of Registration : 2025-10-15
Latest Date of Registration : 2025-10-15
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2025-06-20
Valid Till : 2028-07-07
Written Confirmation Number : WC-0039
Address of the Firm : UNIT-I, Plot Nos. 137, 138, 145 & 146, Sri Venkateswara Co-operative Industrial ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
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&...
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 ...
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...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Selinexor,Carfilzomib,Isatuximab,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Natalie Callander | Karyopharm Therapeutics | University of Wisconsin, Madison
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Selinexor is a cytotoxic drug drug, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of multiple myeloma.
Product Name : Undisclosed
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
March 18, 2026
Lead Product(s) : Montelukast Sodium, Dexamethasone, Paracetamol, Diphenhydramine, Methylprednisolone
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Isatuximab is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Multiple Myeloma.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
April 10, 2024
Lead Product(s) : Carfilzomib, Dexamethasone, Montelukast Sodium, Paracetamol, Diphenhydramine
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Isatuximab is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Multiple Myeloma.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
January 30, 2023
Lead Product(s) : Isatuximab,Cemiplimab,Dexamethasone,Lenalidomide,Pomalidomide,Carfilzomib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Isatuximab is a Antibody drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Multiple Myeloma.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
January 03, 2023
Lead Product(s) : Isatuximab,Carfilzomib,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : CHMP issues positive opinion for second indication for Sarclisa in combination with carfilzomib and dexamethasone for adult patients with multiple myeloma who have received at least one prior therapy.
Product Name : Sarclisa
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
February 26, 2021
Lead Product(s) : Isatuximab,Carfilzomib,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Sarclisa added to carfilzomib and dexamethasone (Sarclisa combination) reduced risk of disease progression or death by 47% versus standard of care carfilzomib and dexamethasone (Kd) alone.
Product Name : Sarclisa
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
June 02, 2020
Lead Product(s) : Isatuximab,Carfilzomib,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Sanofi's Sarclisa Cuts Death Risk In Mutiple Myeloma
Details : Addition of Sarclisa significantly reduced the risk of disease progression or death compared to carfilzomib and dexamethasone alone.
Product Name : Sarclisa
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
May 12, 2020
Lead Product(s) : Isatuximab,Carfilzomib,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Isatuximab is a Antibody drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Multiple Myeloma.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
September 07, 2017
Lead Product(s) : Carfilzomib,Venetoclax,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Genentech
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Carfilzomib is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Multiple Myeloma.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 14, 2016
Lead Product(s) : Ibrutinib,Carfilzomib,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ibrutinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Multiple Myeloma.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 14, 2013
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
(S)-2-((S)-4-methyl-2-((S)-2-(2-morpholinoacetamid...
CAS Number : 868540-16-3
End Use API : Carfilzomib
About The Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercializati...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
(S)-2-amino-4-methyl-1-((R)-2-methyloxiran-2-yl)pe...
CAS Number : 247068-85-5
End Use API : Carfilzomib
About The Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercializati...
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
CAS Number : 247068-85-5
End Use API : Carfilzomib
About The Company : Founded in 2006, ChemExpress provides CRO and CDMO services to pharmaceutical and biotech companies. The company supports small molecules, biologics, and new mo...
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
CAS Number : 247068-82-2
End Use API : Carfilzomib
About The Company : Founded in 2006, ChemExpress provides CRO and CDMO services to pharmaceutical and biotech companies. The company supports small molecules, biologics, and new mo...
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
CAS Number : 868539-98-4
End Use API : Carfilzomib
About The Company : Founded in 2006, ChemExpress provides CRO and CDMO services to pharmaceutical and biotech companies. The company supports small molecules, biologics, and new mo...
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
CAS Number : 868539-99-5
End Use API : Carfilzomib
About The Company : Founded in 2006, ChemExpress provides CRO and CDMO services to pharmaceutical and biotech companies. The company supports small molecules, biologics, and new mo...
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
CAS Number : 868540-15-2
End Use API : Carfilzomib
About The Company : Founded in 2006, ChemExpress provides CRO and CDMO services to pharmaceutical and biotech companies. The company supports small molecules, biologics, and new mo...
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
CAS Number : 1140908-89-9
End Use API : Carfilzomib
About The Company : Founded in 2006, ChemExpress provides CRO and CDMO services to pharmaceutical and biotech companies. The company supports small molecules, biologics, and new mo...
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
Panvo Organics
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Parenteral
Solubilizers
Thickeners and Stabilizers
Fillers, Diluents & Binders
Taste Masking
Emulsifying Agents
Dry Powder Inhalation
Digital Content
DATA COMPILATION #PharmaFlow
STOCK RECAP #PipelineProspector
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
12
PharmaCompass offers a list of Carfilzomib 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 Carfilzomib manufacturer or Carfilzomib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Carfilzomib manufacturer or Carfilzomib supplier.
A Kyprolis manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Kyprolis, including repackagers and relabelers. The FDA regulates Kyprolis manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Kyprolis 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 Kyprolis manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Kyprolis supplier is an individual or a company that provides Kyprolis active pharmaceutical ingredient (API) or Kyprolis finished formulations upon request. The Kyprolis suppliers may include Kyprolis API manufacturers, exporters, distributors and traders.
click here to find a list of Kyprolis suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Kyprolis DMF (Drug Master File) is a document detailing the whole manufacturing process of Kyprolis active pharmaceutical ingredient (API) in detail. Different forms of Kyprolis DMFs exist exist since differing nations have different regulations, such as Kyprolis USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Kyprolis DMF submitted to regulatory agencies in the US is known as a USDMF. Kyprolis USDMF includes data on Kyprolis's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Kyprolis USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Kyprolis suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Kyprolis Drug Master File in Japan (Kyprolis JDMF) empowers Kyprolis API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Kyprolis JDMF during the approval evaluation for pharmaceutical products. At the time of Kyprolis JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Kyprolis suppliers with JDMF 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 Kyprolis Drug Master File in Korea (Kyprolis KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Kyprolis. The MFDS reviews the Kyprolis KDMF as part of the drug registration process and uses the information provided in the Kyprolis KDMF to evaluate the safety and efficacy of the drug.
After submitting a Kyprolis 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 Kyprolis API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Kyprolis suppliers with KDMF on PharmaCompass.
A Kyprolis written confirmation (Kyprolis WC) is an official document issued by a regulatory agency to a Kyprolis manufacturer, verifying that the manufacturing facility of a Kyprolis active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Kyprolis APIs or Kyprolis finished pharmaceutical products to another nation, regulatory agencies frequently require a Kyprolis WC (written confirmation) as part of the regulatory process.
click here to find a list of Kyprolis 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 Kyprolis as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Kyprolis 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 Kyprolis 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 Kyprolis and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Kyprolis NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Kyprolis suppliers with NDC on PharmaCompass.
Kyprolis 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 Kyprolis GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Kyprolis GMP manufacturer or Kyprolis GMP API supplier for your needs.
A Kyprolis CoA (Certificate of Analysis) is a formal document that attests to Kyprolis's compliance with Kyprolis specifications and serves as a tool for batch-level quality control.
Kyprolis CoA mostly includes findings from lab analyses of a specific batch. For each Kyprolis 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.
Kyprolis may be tested according to a variety of international standards, such as European Pharmacopoeia (Kyprolis EP), Kyprolis JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Kyprolis USP).
