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1. (1r,2s,5s)-n-((1s)-1-cyano-2-((3s)-2-oxopyrrolidin-3-yl)ethyl)-6,6-dimethyl-3-(3-methyl-n-(trifluoroacetyl)-l-valyl)-3-azabicyclo(3.1.0)hexane-2-carboxamide
2. Pf-07321332
3. Pf07321332
1. 2628280-40-8
2. 7r9a5p7h32
3. Paxlovid
4. Pf-07321332
5. Pf07321332
6. Nirmatrelvir [usan]
7. (1r,2s,5s)-n-[(1s)-1-cyano-2-[(3s)-2-oxopyrrolidin-3-yl]ethyl]-3-[(2s)-3,3-dimethyl-2-[(2,2,2-trifluoroacetyl)amino]butanoyl]-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide
8. (1r,2s,5s)-n-((1s)-1-cyano-2-((3s)-2-oxopyrrolidin-3-yl)ethyl)-6,6-dimethyl-3-(3-methyl-n-(trifluoroacetyl)-l-valyl)-3-azabicyclo(3.1.0)hexane-2-carboxamide
9. (1r,2s,5s)-n-[(1s)-1-cyano-2-[(3s)-2-oxopyrrolidin-3-yl]ethyl]-3-[(2s)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido)butanoyl]-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide
10. (1r,2s,5s)-n-{(1s)-1-cyano-2-[(3s)-2-oxopyrrolidin-3-yl]ethyl}-3-[(2s)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido)butanoyl]-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide
11. (1r,2s,5s)-n-{(1s)-1-cyano-2-[(3s)-2-oxopyrrolidin-3-yl]ethyl}-6,6-dimethyl-3-[3-methyl-n-(trifluoroacetyl)-l-valyl]-3-azabicyclo[3.1.0]hexane-2-carboxamide
12. 3-azabicyclo(3.1.0)hexane-2-carboxamide, N-((1s)-1-cyano-2-((3s)-2-oxo-3-pyrrolidinyl)ethyl)-3-((2s)-3,3-dimethyl-1-oxo-2-((2,2,2-trifluoroacetyl)amino)butyl)-6,6-dimethyl-, (1r,2s,5s)-
13. 3-azabicyclo[3.1.0]hexane-2-carboxamide, N-[(1s)-1-cyano-2-[(3s)-2-oxo-3-pyrrolidinyl]ethyl]-3-[(2s)-3,3-dimethyl-1-oxo-2-[(2,2,2-trifluoroacetyl)amino]butyl]-6,6-dimethyl-, (1r,2s,5s)-
14. Science.abl4784, 6
15. Nirmatrelvir [inn]
16. Nirmatrelvir [jan]
17. Nirmatrelvir [who-dd]
18. Unii-7r9a5p7h32
19. Pf07321332(nirmatrelvir)
20. Chembl4802135
21. Gtpl11503
22. Chebi:170007
23. Bdbm496902
24. Dtxsid501336829
25. Ex-a5024
26. Paxlovid (nirmatrelvir + Ritonavir)
27. Who 12161
28. At31194
29. Ac-35259
30. Example E61 [wo2021250648a1]
31. Paxlovid Component Pf-07321332
32. Hy-138687
33. 870124 More Info Pf-00835231
34. Cs-0166635
35. Pf 07321332
36. (1r,2s,5s)-n-((s)-1-cyano-2-((s)-2-oxopyrrolidin-3-yl)ethyl)-3-((s)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido)butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide
37. (1s,3as,4ar)-n-[(1s)-1-cyano-2-[(3s)-2-oxotetrahydro-1h-pyrrol-3-yl]ethyl]-2-[(2s)-3,3-dimethyl-1-oxo-2-[(trifluoroacetyl)amino]butyl]-4,4-dimethyl-2,3,3a,4a-tetrahydro-1h-cyclopropa[1,2-c]pyrrole-1-carboxamide
Molecular Weight | 499.5 g/mol |
---|---|
Molecular Formula | C23H32F3N5O4 |
XLogP3 | 2.2 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 8 |
Rotatable Bond Count | 7 |
Exact Mass | 499.24063901 g/mol |
Monoisotopic Mass | 499.24063901 g/mol |
Topological Polar Surface Area | 131 Ų |
Heavy Atom Count | 35 |
Formal Charge | 0 |
Complexity | 964 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 6 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Nirmatrelvir has received FDA emergency use authorization, in combination with [ritonavir], for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Paxlovid is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID 19 (see section 5. 1).
Nirmatrelvir is administered alongside ritonavir, a potent inhibitor of CYP3A enzymes, in order to inhibit its metabolism and increase plasma nirmatrelvir concentrations. While therapeutically beneficial, the use of ritonavir poses a significant risk of drug interaction due to its potent inhibition profile - patients and clinicians should consult the prescribing information for Paxlovid (nirmatrelvir and ritonavir) to evaluate any potential for drug interaction with existing medications prior to the initiation of Paxlovid.
Viral Protease Inhibitors
Compounds that specifically inhibit PROTEOLYTIC ENZYMES that are encoded by VIRUSES. (See all compounds classified as Viral Protease Inhibitors.)
Not yet assigned
Absorption
The median Tmax of nirmatrelvir, when given with ritonavir, is 3 hours. After a single oral dose of 300mg nirmatrelvir and 100mg ritonavir in healthy subjects, the Cmax and AUCinf of nirmatrelvir were 2.21 g/mL and 23.01 g*hr/mL, respectively.
Route of Elimination
The major route of nirmaltrevir elimination is via renal elimination, due in part to its coadministration with ritonavir which inhibits its metabolism. Following oral administration alongside ritonavir, approximately 49.6% of drug-related material was recovered in the feces and 35.3% was recovered in the urine.
Volume of Distribution
The mean volume of distribution of nirmatrelvir, when given with ritonavir, is 104.7 liters.
Clearance
The mean oral clearance of nirmatrelvir, administered with ritonavir, is 8.99 L/h.
Nirmatrelvir is a substrate of CYP3A4, but undergoes minimal metabolism when administered alongside ritonavir.
The mean half-life of nirmatrelvir, administered alongside ritonavir, is 6.05 hours.
Nirmatrelvir is an inhibitor of a cysteine residue in the 3C-like protease (3CLPRO) of SARS-CoV-2. This cysteine is responsible to the activity of the 3CLPRO of SARS-CoV-2 and potentially other members of the coronavirus family. The 3CLPRO, also known as the main protease or non structural protein 5, is responsible for cleaving polyproteins 1a and 1ab. These polyproteins contain the 3CLPRO itself, a papain-like (PL) cysteine protease, and 14 other nonstructural proteins. Without the activity of the 3CLPRO, nonstructural proteins (including proteases) cannot be released to perform their functions, inhibiting viral replication.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
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Century has been an API manufacturer for over 30 years & is the partner of choice for multipurpose custom manufacturing projects.
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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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.
Lead Product(s): Nirmatrelvir,Ritonavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Paxzen
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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
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
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.
Lead Product(s): Nirmatrelvir,Ritonavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Paxlovid
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 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
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, among others.
Lead Product(s): Nirmatrelvir,Ritonavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Nirmatrelvir-Generic
Study Phase: Phase II/ Phase IIIProduct Type: Small molecule
Sponsor: The Medicines Patent Pool
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 22, 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
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.
Lead Product(s): Nirmatrelvir,Ritonavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Paxlovid-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 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
Details:
Under the agreement, Pfizer will commercialize Paxlovid (nirmatrelvir with ritonavir), the first oral antiviral pill approved by the U.S. Food and Drug Administration, for the treatment of privately insured commercial patients with prices to be negotiated with payers.
Lead Product(s): Nirmatrelvir,Ritonavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Paxlovid
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: U.S. Government
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 13, 2023
Lead Product(s) : Nirmatrelvir,Ritonavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : U.S. Government
Deal Size : Undisclosed
Deal Type : Agreement
Pfizer Amends U.S. Government Paxlovid Supply Agreement and Updates Full-Year 2023 Guidance
Details : Under the agreement, Pfizer will commercialize Paxlovid (nirmatrelvir with ritonavir), the first oral antiviral pill approved by the U.S. Food and Drug Administration, for the treatment of privately insured commercial patients with prices to be negotiate...
Brand Name : Paxlovid
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 13, 2023
Details:
The partnership aims to launch a local brand of the Covid-19 oral therapeutic treatment Paxlovid (nirmatrelvir/ritonavir) in an attempt to improve the access for treatment in China.
Lead Product(s): Nirmatrelvir,Ritonavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Paxlovid
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Pfizer Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 29, 2023
Lead Product(s) : Nirmatrelvir,Ritonavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Undisclosed
Deal Type : Partnership
Details : The partnership aims to launch a local brand of the Covid-19 oral therapeutic treatment Paxlovid (nirmatrelvir/ritonavir) in an attempt to improve the access for treatment in China.
Brand Name : Paxlovid
Molecule Type : Small molecule
Upfront Cash : Undisclosed
June 29, 2023
Details:
Paxlovid (nirmatrelvir tablets and ritonavir tablets) is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It is being developed for the treatment of long COVID-19 in adults.
Lead Product(s): Nirmatrelvir,Ritonavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Paxlovid
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2023
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
Pfizer’s PAXLOVID™ Receives FDA Approval for Adult Patients at High Risk of Progression to Sev...
Details : Paxlovid (nirmatrelvir tablets and ritonavir tablets) is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It is being developed for the treatment of long COVID-19 in adults.
Brand Name : Paxlovid
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 25, 2023
Details:
Paxlovid™ (nirmatrelvir tablets and ritonavir tablets) is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It is being developed for the treatment of long COVID-19 in adults.
Lead Product(s): Nirmatrelvir,Ritonavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Paxlovid
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2023
Lead Product(s) : Nirmatrelvir,Ritonavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Not Applicable
Deal Type : Not Applicable
New Yale Study Evaluates Paxlovid's Use in Long COVID Recovery
Details : Paxlovid™ (nirmatrelvir tablets and ritonavir tablets) is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It is being developed for the treatment of long COVID-19 in adults.
Brand Name : Paxlovid
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 21, 2023
Details:
Paxlovid™ (nirmatrelvir tablets and ritonavir tablets) is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It is being developed for the treatment of mild-to-moderate COVID-19 in adults.
Lead Product(s): Nirmatrelvir,Ritonavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Paxlovid
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2023
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
FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for Pfizer’s PAXLOVID...
Details : Paxlovid™ (nirmatrelvir tablets and ritonavir tablets) is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It is being developed for the treatment of mild-to-moderate COVID-19 in adults.
Brand Name : Paxlovid
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 16, 2023
Details:
Hetero’s ‘NIRMACOM’ (nirmatrelvir), a generic version of Pfizer’s COVID-19 oral antiviral drug ‘PAXLOVID’ is co-packaged with ritonavir tablets. The combi pack, launched by Hetero as NIRMACOM, will contain nirmatrelvir 150 mg (2 tablets) and ritonavir 100mg (1 tablet).
Lead Product(s): Nirmatrelvir,Ritonavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Nirmacom
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 26, 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
Hetero’s ‘NIRMACOM’ is World’s First Generic Version Of COVID-19 Oral Drug ‘PAXLOVID’ ...
Details : Hetero’s ‘NIRMACOM’ (nirmatrelvir), a generic version of Pfizer’s COVID-19 oral antiviral drug ‘PAXLOVID’ is co-packaged with ritonavir tablets. The combi pack, launched by Hetero as NIRMACOM, will contain nirmatrelvir 150 mg (2 tablets) and ...
Brand Name : Nirmacom
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 26, 2022
Regulatory Info :
Registration Country : Switzerland
Brand Name : Paxlovid
Dosage Form : Tablets
Dosage Strength : 150mg and 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 150MG; 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 150MG; 100MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Global Sales Information
Dosage Form : Tablets
Dosage Strength : 150mg and 100mg
Price Per Pack (Euro) : 958.62
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Market Place
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ABOUT THIS PAGE
A Paxlovid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Paxlovid, including repackagers and relabelers. The FDA regulates Paxlovid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Paxlovid 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 Paxlovid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Paxlovid supplier is an individual or a company that provides Paxlovid active pharmaceutical ingredient (API) or Paxlovid finished formulations upon request. The Paxlovid suppliers may include Paxlovid API manufacturers, exporters, distributors and traders.
click here to find a list of Paxlovid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Paxlovid DMF (Drug Master File) is a document detailing the whole manufacturing process of Paxlovid active pharmaceutical ingredient (API) in detail. Different forms of Paxlovid DMFs exist exist since differing nations have different regulations, such as Paxlovid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Paxlovid DMF submitted to regulatory agencies in the US is known as a USDMF. Paxlovid USDMF includes data on Paxlovid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Paxlovid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Paxlovid 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 Paxlovid Drug Master File in Korea (Paxlovid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Paxlovid. The MFDS reviews the Paxlovid KDMF as part of the drug registration process and uses the information provided in the Paxlovid KDMF to evaluate the safety and efficacy of the drug.
After submitting a Paxlovid 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 Paxlovid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Paxlovid 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 Paxlovid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Paxlovid 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 Paxlovid 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 Paxlovid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Paxlovid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Paxlovid suppliers with NDC on PharmaCompass.
Paxlovid 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 Paxlovid 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 Paxlovid GMP manufacturer or Paxlovid GMP API supplier for your needs.
A Paxlovid CoA (Certificate of Analysis) is a formal document that attests to Paxlovid's compliance with Paxlovid specifications and serves as a tool for batch-level quality control.
Paxlovid CoA mostly includes findings from lab analyses of a specific batch. For each Paxlovid 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.
Paxlovid may be tested according to a variety of international standards, such as European Pharmacopoeia (Paxlovid EP), Paxlovid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Paxlovid USP).
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