01 1API Corporation, Yoshitomi Plant
02 1Yuil Farm Tech Co., Ltd.
01 1Korea Santen Pharmaceutical Co., Ltd.
02 1Yuil Farm Tech Co., Ltd.
01 2Femirolast potassium
01 2Japan
Registrant Name : Korea Santen Pharmaceutical Co., Ltd.
Registration Date : 2023-05-26
Registration Number : 20230526-209-J-1498
Manufacturer Name : API Corporation, Yoshitomi P...
Manufacturer Address : 955 Koiwai, Yoshitomimachi, Chikujo-gun, Fukuoka 871-0801, Japan
Registrant Name : Yuil Farm Tech Co., Ltd.
Registration Date : 2022-08-16
Registration Number : 20220816-209-J-1344
Manufacturer Name : Yuil Farm Tech Co., Ltd.
Manufacturer Address : 3 Mulmi-gil, Iwol-myeon, Jincheon-gun, Chungcheongbuk-do
A Pemirolast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pemirolast, including repackagers and relabelers. The FDA regulates Pemirolast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pemirolast API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Pemirolast supplier is an individual or a company that provides Pemirolast active pharmaceutical ingredient (API) or Pemirolast finished formulations upon request. The Pemirolast suppliers may include Pemirolast API manufacturers, exporters, distributors and traders.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Pemirolast Drug Master File in Korea (Pemirolast KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pemirolast. The MFDS reviews the Pemirolast KDMF as part of the drug registration process and uses the information provided in the Pemirolast KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pemirolast 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 Pemirolast API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pemirolast suppliers with KDMF on PharmaCompass.
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