Synopsis
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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
EU-WC
NDC
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
BR, CA, ...
Sumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-04
Pay. Date : 2015-09-09
DMF Number : 29506
Submission : 2015-08-27
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-30
Pay. Date : 2023-06-27
DMF Number : 23996
Submission : 2010-07-26
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 : 2012-11-23
Pay. Date : 2012-11-13
DMF Number : 22160
Submission : 2008-10-31
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 20-06-2025
Valid Till : 07-07-2028
Written Confirmation Number : WC-0039
Address of the Firm : UNIT-I, Plot Nos. 137, 138, 145 & 146, Sri Venkateswara Co-operative Industrial ...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
Lead Product(s) : Isatuximab,Bortezomib,Lenalidomide
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sarclisa Approved in Japan for Patients with Newly Diagnosed Multiple Myeloma
Details : Sarclisa (isatuximab) approved as a first anti-CD38 therapy in combination with Bortezomib and Dexamethasone soc treatment for patients with newly diagnosed transplant-ineligible multiple myeloma.
Product Name : Sarclisa
Product Type : Antibody
Upfront Cash : Inapplicable
February 25, 2025
Lead Product(s) : Isatuximab,Bortezomib,Lenalidomide
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sarclisa Becomes First CD38 Therapy Approved in China for Myeloma
Details : Sarclisa (isatuximab) approved as a first anti-CD38 therapy in combination with Bortezomib and Dexamethasone soc treatment for patients with newly diagnosed transplant-ineligible multiple myeloma.
Product Name : Sarclisa
Product Type : Antibody
Upfront Cash : Inapplicable
January 31, 2025
Lead Product(s) : Isatuximab,Bortezomib,Lenalidomide
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sarclisa Approved in EU as First Anti-CD38 Therapy for Multiple Myeloma with VRd
Details : Sarclisa (isatuximab) approved as a first anti-CD38 therapy in combination with Bortezomib and Dexamethasone soc treatment for patients with newly diagnosed transplant-ineligible multiple myeloma.
Product Name : Sarclisa
Product Type : Antibody
Upfront Cash : Inapplicable
January 22, 2025
Lead Product(s) : Isatuximab,Bortezomib,Lenalidomide
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sarclisa Recommended for EU Approval for Newly Diagnosed Multiple Myeloma
Details : Sarclisa (isatuximab) approved as a first anti-CD38 therapy in combination with Bortezomib and Dexamethasone soc treatment for patients with newly diagnosed transplant-ineligible multiple myeloma.
Product Name : Sarclisa
Product Type : Antibody
Upfront Cash : Inapplicable
November 14, 2024
Lead Product(s) : Isatuximab,Bortezomib,Lenalidomide
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sanofi Wins US Approval for Multiple Myeloma Drug in Newly Diagnosed Patients
Details : Sarclisa (isatuximab) approved as a first anti-CD38 therapy in combination with Bortezomib and Dexamethasone soc treatment for patients with newly diagnosed transplant-ineligible multiple myeloma.
Product Name : Sarclisa
Product Type : Antibody
Upfront Cash : Inapplicable
September 21, 2024
Lead Product(s) : Isatuximab,Bortezomib,Lenalidomide
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sarclisa Treatment Significantly Improves Survival in Multiple Myeloma Patients
Details : Sarclisa (isatuximab) will be the first anti-CD38 therapy in combination with Bortezomib and Dexamethasone soc treatment for patients with newly diagnosed transplant-ineligible multiple myeloma.
Product Name : Sarclisa
Product Type : Antibody
Upfront Cash : Inapplicable
August 08, 2024
Lead Product(s) : Isatuximab,Bortezomib,Lenalidomide
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sarclisa Accepted for FDA Priority Review in Newly Diagnosed Multiple Myeloma
Details : Sarclisa (isatuximab) will be the first anti-CD38 therapy in combination with Bortezomib and Dexamethasone soc treatment for patients with newly diagnosed transplant-ineligible multiple myeloma.
Product Name : Sarclisa
Product Type : Antibody
Upfront Cash : Inapplicable
May 27, 2024
Lead Product(s) : Isatuximab,Bortezomib,Lenalidomide
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sarclisa® (isatuximab) Phase 3 Trial Met Primary Endpoint of Progression Free Survival in Patient...
Details : Sarclisa (isatuximab) is a CD38 monoclonal antibody in combination with standard-of-care bortezomib, lenalidomide and dexamethasone is being evaluated in newly diagnosed multiple myeloma not eligible for transplant.
Product Name : Sarclisa
Product Type : Antibody
Upfront Cash : Inapplicable
August 12, 2023
Lead Product(s) : Isatuximab,Bortezomib,Lenalidomide,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Antibody
Upfront Cash : Inapplicable
October 24, 2017
Lead Product(s) : Lenalidomide,Bortezomib,Cyclophosphamide,Dexamethasone,Isatuximab
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 31, 2015
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
CAS Number : 150736-72-4
End Use API : Bortezomib
About The Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipi...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Evonik
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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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Chewable & Orodispersible Aids
Direct Compression
Taste Masking
Disintegrants & Superdisintegrants
Parenteral
Co-Processed Excipients
Granulation
Topical
Solubilizers
Thickeners and Stabilizers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Bortezomib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Bortezomib manufacturer or Bortezomib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bortezomib manufacturer or Bortezomib supplier.
PharmaCompass also assists you with knowing the Bortezomib API Price utilized in the formulation of products. Bortezomib API Price is not always fixed or binding as the Bortezomib Price is obtained through a variety of data sources. The Bortezomib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bortezomib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bortezomib, including repackagers and relabelers. The FDA regulates Bortezomib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bortezomib 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 Bortezomib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bortezomib supplier is an individual or a company that provides Bortezomib active pharmaceutical ingredient (API) or Bortezomib finished formulations upon request. The Bortezomib suppliers may include Bortezomib API manufacturers, exporters, distributors and traders.
click here to find a list of Bortezomib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bortezomib DMF (Drug Master File) is a document detailing the whole manufacturing process of Bortezomib active pharmaceutical ingredient (API) in detail. Different forms of Bortezomib DMFs exist exist since differing nations have different regulations, such as Bortezomib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bortezomib DMF submitted to regulatory agencies in the US is known as a USDMF. Bortezomib USDMF includes data on Bortezomib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bortezomib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bortezomib 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 Bortezomib Drug Master File in Japan (Bortezomib JDMF) empowers Bortezomib 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 Bortezomib JDMF during the approval evaluation for pharmaceutical products. At the time of Bortezomib 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 Bortezomib 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 Bortezomib Drug Master File in Korea (Bortezomib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bortezomib. The MFDS reviews the Bortezomib KDMF as part of the drug registration process and uses the information provided in the Bortezomib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bortezomib 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 Bortezomib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bortezomib suppliers with KDMF on PharmaCompass.
A Bortezomib written confirmation (Bortezomib WC) is an official document issued by a regulatory agency to a Bortezomib manufacturer, verifying that the manufacturing facility of a Bortezomib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bortezomib APIs or Bortezomib finished pharmaceutical products to another nation, regulatory agencies frequently require a Bortezomib WC (written confirmation) as part of the regulatory process.
click here to find a list of Bortezomib 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 Bortezomib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bortezomib 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 Bortezomib 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 Bortezomib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bortezomib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bortezomib suppliers with NDC on PharmaCompass.
Bortezomib 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 Bortezomib 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 Bortezomib GMP manufacturer or Bortezomib GMP API supplier for your needs.
A Bortezomib CoA (Certificate of Analysis) is a formal document that attests to Bortezomib's compliance with Bortezomib specifications and serves as a tool for batch-level quality control.
Bortezomib CoA mostly includes findings from lab analyses of a specific batch. For each Bortezomib 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.
Bortezomib may be tested according to a variety of international standards, such as European Pharmacopoeia (Bortezomib EP), Bortezomib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bortezomib USP).
