Synopsis
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CEP/COS
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JDMF
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VMF
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EDQM
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USP
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JP
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Others
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FDA Orange Book
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Australia
DRUG PRODUCT COMPOSITIONS
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FDF
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36910
Submission : 2022-03-25
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
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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) : Nirmatrelvir,Ritonavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Paxzen
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 09, 2022
Lead Product(s) : Nirmatrelvir,Ritonavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Paxlovid
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 19, 2022
Lead Product(s) : Nirmatrelvir,Ritonavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Zenara Pharma to Launch Generic Paxlovid Soon
Details : Zenara said Nirmatrelvir and Ritonavir tablets will soon be available in a combi-pack, sold under the brand name Paxzen, as a treatment of mild-to-moderate Covid-19 in adults.
Product Name : Paxzen
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 28, 2022
Lead Product(s) : Nirmatrelvir,Ritonavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Paxlovid-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 18, 2022
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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DATA COMPILATION #PharmaFlow
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Global Sales Information
US Medicaid Prescriptions
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ABOUT THIS PAGE
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PharmaCompass offers a list of Nirmatrelvir 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 Nirmatrelvir manufacturer or Nirmatrelvir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nirmatrelvir manufacturer or Nirmatrelvir supplier.
PharmaCompass also assists you with knowing the Nirmatrelvir API Price utilized in the formulation of products. Nirmatrelvir API Price is not always fixed or binding as the Nirmatrelvir Price is obtained through a variety of data sources. The Nirmatrelvir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
A Nirmatrelvir written confirmation (Nirmatrelvir WC) is an official document issued by a regulatory agency to a Nirmatrelvir manufacturer, verifying that the manufacturing facility of a Nirmatrelvir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nirmatrelvir APIs or Nirmatrelvir finished pharmaceutical products to another nation, regulatory agencies frequently require a Nirmatrelvir WC (written confirmation) as part of the regulatory process.
click here to find a list of Nirmatrelvir 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 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).
