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Looking for 2628280-40-8 / Nirmatrelvir API manufacturers, exporters & distributors?

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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.

API | Excipient name

Nirmatrelvir

Synonyms

2628280-40-8, 7r9a5p7h32, Paxlovid, Pf-07321332, Pf07321332, Nirmatrelvir [usan]

Cas Number

2628280-40-8

Unique Ingredient Identifier (UNII)

7R9A5P7H32

About Nirmatrelvir

Nirmatrelvir is an orally bioavailable, peptidomimetic inhibitor of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) main protease (Mpro; 3C-like protease; 3CL protease; 3CLpro; nsp5 protease), with potential antiviral activity against SARS-CoV-2 and other coronaviruses. Upon oral administration, nirmatrelvir selectively targets, binds to, and inhibits the activity of SARS-CoV-2 Mpro. This inhibits the proteolytic cleavage of viral polyproteins, thereby inhibiting the formation of viral proteins including helicase, single-stranded-RNA-binding protein, RNA-dependent RNA polymerase, 20-O-ribose methyltransferase, endoribonuclease and exoribonuclease. This prevents viral transcription and replication.

Nirmatrelvir Manufacturers

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.

Nirmatrelvir Suppliers

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.

Nirmatrelvir USDMF

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.

Nirmatrelvir NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Nirmatrelvir API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Nirmatrelvir CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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