01 1Estifarm Co., Ltd.
01 1Estifarm Co., Ltd.
01 1Evogliptin tartrate
01 1South Korea
Registrant Name : Estifarm Co., Ltd.
Registration Date : 2015-10-07
Registration Number : 1301-4-ND
Manufacturer Name : Estifarm Co., Ltd.
Manufacturer Address : 231, Hyeop-ro, Siheung-si, Gyeonggi-do
A Evogliptin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Evogliptin, including repackagers and relabelers. The FDA regulates Evogliptin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Evogliptin 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 Evogliptin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Evogliptin supplier is an individual or a company that provides Evogliptin active pharmaceutical ingredient (API) or Evogliptin finished formulations upon request. The Evogliptin suppliers may include Evogliptin API manufacturers, exporters, distributors and traders.
click here to find a list of Evogliptin 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 Evogliptin Drug Master File in Korea (Evogliptin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Evogliptin. The MFDS reviews the Evogliptin KDMF as part of the drug registration process and uses the information provided in the Evogliptin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Evogliptin 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 Evogliptin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Evogliptin suppliers with KDMF on PharmaCompass.
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