01 1Changzhou SynTheAll Pharmaceutical Co., Ltd
02 1Jilin Asymchem Laboratories Co., Ltd
03 1Pfizer Ireland Pharmaceuticals
01 3Korea Pfizer Pharmaceutical Co., Ltd.
01 3Nirmatrelvir
01 1Japan
02 2U.S.A
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2023-07-14
Registration Number : Number 87-33-ND
Manufacturer Name : Changzhou SynTheAll Pharmace...
Manufacturer Address : No. 589 North Yulong Road, Xinbei District Changzhou, CH213127, China
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2023-07-14
Registration Number : Number 87-34-ND
Manufacturer Name : Jilin Asymchem Laboratories ...
Manufacturer Address : No.99, Hongda Road, Economic Development Zone, Dunhua, Jilin, 133700, China
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2023-07-14
Registration Number : Number 87-35-ND
Manufacturer Name : Pfizer Ireland Pharmaceutica...
Manufacturer Address : Ringaskiddy Active Pharmaceutical Ingredient Plant, PO Box 140, Ringaskiddy, County C...
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.
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.
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