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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, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
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 ...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...
Century has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.
About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience in manufacturing APIs. It has been supplying APIs produced in-house to several major pharma companies in In...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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Drugs in Development
Lead Product(s) : Nirmatrelvir,Ritonavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Zenara Launches Generic Version Of Pfizer Covid Drug Paxlovid
Details : Paxzen (nirmatrelvir) is an oral protease inhibitor that is active against MPRO, a viral protease that plays an essential role in viral replication by cleaving the 2 viral polyproteins.
Brand Name : Paxzen
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 09, 2022
Lead Product(s) : Nirmatrelvir,Ritonavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Hyderabad's Biophore To Manufacture Ingredients of Pfizer's Covid Drug
Details : Paxlovid (Nirmatrelvir) is an oral protease inhibitor that is active against MPRO, a viral protease that plays an essential role in viral replication by cleaving the 2 viral polyproteins.
Brand Name : Paxlovid
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 19, 2022
Lead Product(s) : Nirmatrelvir,Ritonavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : The Medicines Patent Pool
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Nortec Química Receives License From The Medicines Patent Pool (MPP) to Produce API Nirmatrelvir ...
Details : With this agreement, the active pharmaceutical ingredient nirmatrelvir can be fully manufactured in Brazil by Nortec, ensuring safety and adherence to treatment for countries such as: South Africa, Tanzania, Venezuela, Bolivia, Ethiopia, Haiti, Honduras,...
Brand Name : Nirmatrelvir-Generic
Molecule Type : Small molecule
Upfront Cash : Undisclosed
March 22, 2022
Lead Product(s) : Nirmatrelvir,Ritonavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Granules India Receives Licences from MPP to Market Nirmatrelvir; Ritonavir
Details : Paxlovid generic version (nirmatrelvir tablets and ritonavir tablets) is a SARS-CoV-2 Mpro inhibitor therapy. It is been approved for the treatment of long COVID-19 in adults.
Brand Name : Paxlovid-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 18, 2022
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ABOUT THIS PAGE
A Nirmatrelvir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nirmatrelvir, including repackagers and relabelers. The FDA regulates Nirmatrelvir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nirmatrelvir 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 Nirmatrelvir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nirmatrelvir supplier is an individual or a company that provides Nirmatrelvir active pharmaceutical ingredient (API) or Nirmatrelvir finished formulations upon request. The Nirmatrelvir suppliers may include Nirmatrelvir API manufacturers, exporters, distributors and traders.
click here to find a list of Nirmatrelvir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nirmatrelvir DMF (Drug Master File) is a document detailing the whole manufacturing process of Nirmatrelvir active pharmaceutical ingredient (API) in detail. Different forms of Nirmatrelvir DMFs exist exist since differing nations have different regulations, such as Nirmatrelvir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nirmatrelvir DMF submitted to regulatory agencies in the US is known as a USDMF. Nirmatrelvir USDMF includes data on Nirmatrelvir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nirmatrelvir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nirmatrelvir 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 Nirmatrelvir Drug Master File in Korea (Nirmatrelvir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nirmatrelvir. The MFDS reviews the Nirmatrelvir KDMF as part of the drug registration process and uses the information provided in the Nirmatrelvir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nirmatrelvir 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 Nirmatrelvir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nirmatrelvir suppliers with KDMF 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 Nirmatrelvir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nirmatrelvir 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 Nirmatrelvir 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 Nirmatrelvir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nirmatrelvir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nirmatrelvir suppliers with NDC on PharmaCompass.
Nirmatrelvir 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 Nirmatrelvir 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 Nirmatrelvir GMP manufacturer or Nirmatrelvir GMP API supplier for your needs.
A Nirmatrelvir CoA (Certificate of Analysis) is a formal document that attests to Nirmatrelvir's compliance with Nirmatrelvir specifications and serves as a tool for batch-level quality control.
Nirmatrelvir CoA mostly includes findings from lab analyses of a specific batch. For each Nirmatrelvir 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.
Nirmatrelvir may be tested according to a variety of international standards, such as European Pharmacopoeia (Nirmatrelvir EP), Nirmatrelvir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nirmatrelvir USP).
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