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List of Drug Master Files (KDMF) for Paxlovid Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Changzhou SynTheAll Pharmaceutical Co., Ltd (1)

02 Jilin Asymchem Laboratories Co., Ltd (1)

03 Pfizer Ireland Pharmaceuticals (1)

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01 Pfizer Pharmaceuticals Korea Co., Ltd. (3)

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01 Nirmatrelvir (3)

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01 Japan (1)

02 U.S.A (2)

URL Supplier Web Content
Pfizer Pharmaceuticals Korea Co., Ltd.
2023-07-14
Wed87-33-ND
Changzhou SynTheAll Pharm...
China
No. 589 North Yulong Road...
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Pfizer Pharmaceuticals Korea Co., Ltd.
2023-07-14
Wed87-34-ND
Jilin Asymchem Laboratori...
China
No.99, Hongda Road, Econo...
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Pfizer Pharmaceuticals Korea Co., Ltd.
2023-07-14
Wed87-35-ND
Pfizer Ireland Pharmaceut...
Ireland
Ringaskiddy Active Pharma...
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Looking for 2628280-40-8 / Nirmatrelvir API manufacturers, exporters & distributors?

Nirmatrelvir manufacturers, exporters & distributors 1

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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.

Paxlovid Manufacturers

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.

Paxlovid Suppliers

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.

Paxlovid KDMF

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.

Paxlovid Manufacturers | Traders | Suppliers

Paxlovid Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Paxlovid

Get in contact with the supplier of your choice:

  1. Mitsubishi Tanabe Pharma
  2. Pfizer Inc
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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