01 1Estech Pharma Co., Ltd.
02 1Pharmacostech Co., Ltd. @ [Starting Material Manufacturing Plant] SK Biopharmaceuticals, CMS Plant
01 1Pharmacostec Co., Ltd.
02 1Polaris AI Pharma Co., Ltd.
01 2Mirodenafil
01 2South Korea
Registrant Name : Polaris AI Pharma Co., Ltd.
Registration Date : 2021-02-09
Registration Number : 1962-7-ND
Manufacturer Name : Estech Pharma Co., Ltd.
Manufacturer Address : 25 Balan Industrial Complex-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, 34 Block 10-1...
Registrant Name : Pharmacostec Co., Ltd.
Registration Date : 2015-08-24
Registration Number : 2572-2-ND
Manufacturer Name : Pharmacostech Co., Ltd. @ [S...
Manufacturer Address : 47, Yakjedanji-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do @ 325, Expo-ro, Yuseong-gu,...
A Mirodenafil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirodenafil, including repackagers and relabelers. The FDA regulates Mirodenafil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirodenafil 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 Mirodenafil supplier is an individual or a company that provides Mirodenafil active pharmaceutical ingredient (API) or Mirodenafil finished formulations upon request. The Mirodenafil suppliers may include Mirodenafil 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 Mirodenafil Drug Master File in Korea (Mirodenafil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mirodenafil. The MFDS reviews the Mirodenafil KDMF as part of the drug registration process and uses the information provided in the Mirodenafil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mirodenafil 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 Mirodenafil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mirodenafil suppliers with KDMF on PharmaCompass.
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