Synopsis
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DRUG PRODUCT COMPOSITIONS
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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.
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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]EU WC
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
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
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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
Panvo Organics
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Digital Content
DATA COMPILATION #PharmaFlow
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NEWS #PharmaBuzz
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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, 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 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, and COA 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, and COA 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.
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 Carfilzomib Drug Master File in Japan (Carfilzomib JDMF) empowers Carfilzomib 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 Carfilzomib JDMF during the approval evaluation for pharmaceutical products. At the time of Carfilzomib 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 Carfilzomib 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 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, 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).
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