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USDMF
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-06
Valid Till : 2025-07-07
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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Drugs in Development
Lead Product(s) : Isatuximab,Carfilzomib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
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
Upfront Cash : Inapplicable
February 26, 2021
Lead Product(s) : Isatuximab,Carfilzomib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
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
Upfront Cash : Inapplicable
December 05, 2020
Lead Product(s) : Isatuximab,Carfilzomib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
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
Upfront Cash : Inapplicable
February 06, 2020
Lead Product(s) : Carfilzomib,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Kyprolis-Generic (carfilzomib) is a proteasome inhibitor, small molecule drug candidate, which is indicated for the treatment of patients with relapsed or refractory multiple myeloma as monotherapy or in combination with dexamethasone or with lenalidomid...
Product Name : Kyprolis-Generic
Product Type : Peptide
Upfront Cash : Inapplicable
June 16, 2021
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ABOUT THIS PAGE
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PharmaCompass offers a list of Carfilzomib 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 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.
PharmaCompass also assists you with knowing the Carfilzomib API Price utilized in the formulation of products. Carfilzomib API Price is not always fixed or binding as the Carfilzomib Price is obtained through a variety of data sources. The Carfilzomib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Carfilzomib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carfilzomib, including repackagers and relabelers. The FDA regulates Carfilzomib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carfilzomib 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 Carfilzomib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Carfilzomib supplier is an individual or a company that provides Carfilzomib active pharmaceutical ingredient (API) or Carfilzomib finished formulations upon request. The Carfilzomib suppliers may include Carfilzomib API manufacturers, exporters, distributors and traders.
click here to find a list of Carfilzomib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carfilzomib DMF (Drug Master File) is a document detailing the whole manufacturing process of Carfilzomib active pharmaceutical ingredient (API) in detail. Different forms of Carfilzomib DMFs exist exist since differing nations have different regulations, such as Carfilzomib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carfilzomib DMF submitted to regulatory agencies in the US is known as a USDMF. Carfilzomib USDMF includes data on Carfilzomib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carfilzomib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Carfilzomib 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 Carfilzomib Drug Master File in Korea (Carfilzomib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Carfilzomib. The MFDS reviews the Carfilzomib KDMF as part of the drug registration process and uses the information provided in the Carfilzomib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Carfilzomib 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 Carfilzomib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Carfilzomib suppliers with KDMF on PharmaCompass.
A Carfilzomib written confirmation (Carfilzomib WC) is an official document issued by a regulatory agency to a Carfilzomib manufacturer, verifying that the manufacturing facility of a Carfilzomib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Carfilzomib APIs or Carfilzomib finished pharmaceutical products to another nation, regulatory agencies frequently require a Carfilzomib WC (written confirmation) as part of the regulatory process.
click here to find a list of Carfilzomib 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 Carfilzomib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Carfilzomib 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 Carfilzomib 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 Carfilzomib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Carfilzomib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Carfilzomib suppliers with NDC on PharmaCompass.
Carfilzomib 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 Carfilzomib 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 Carfilzomib GMP manufacturer or Carfilzomib GMP API supplier for your needs.
A Carfilzomib CoA (Certificate of Analysis) is a formal document that attests to Carfilzomib's compliance with Carfilzomib specifications and serves as a tool for batch-level quality control.
Carfilzomib CoA mostly includes findings from lab analyses of a specific batch. For each Carfilzomib 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.
Carfilzomib may be tested according to a variety of international standards, such as European Pharmacopoeia (Carfilzomib EP), Carfilzomib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Carfilzomib USP).
