01 1Estifarm Co., Ltd.
01 1Estifarm Co., Ltd.
01 1Udenafil
01 1South Korea
Registrant Name : Estifarm Co., Ltd.
Registration Date : 2005-11-29
Registration Number : 15-1-ND
Manufacturer Name : Estifarm Co., Ltd.
Manufacturer Address : 171 Haean-ro, Danwon-gu, Ansan-si, Gyeonggi-do
A Udenafil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Udenafil, including repackagers and relabelers. The FDA regulates Udenafil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Udenafil 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 Udenafil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Udenafil supplier is an individual or a company that provides Udenafil active pharmaceutical ingredient (API) or Udenafil finished formulations upon request. The Udenafil suppliers may include Udenafil API manufacturers, exporters, distributors and traders.
click here to find a list of Udenafil 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 Udenafil Drug Master File in Korea (Udenafil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Udenafil. The MFDS reviews the Udenafil KDMF as part of the drug registration process and uses the information provided in the Udenafil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Udenafil 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 Udenafil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Udenafil suppliers with KDMF on PharmaCompass.
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