01 1ST Pharm Co., Ltd.
01 1ST Pharm Co., Ltd.
01 1Evogliptin tartrate
01 1South Korea
Registrant Name : ST Pharm Co., Ltd.
Registration Date : 2015-10-07
Registration Number : 1301-4-ND
Manufacturer Name : ST Pharm Co., Ltd.
Manufacturer Address : 231 Hyeopnyeop-ro, Siheung-si, Gyeonggi-do
44
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A 09118300L7 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 09118300L7, including repackagers and relabelers. The FDA regulates 09118300L7 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 09118300L7 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 09118300L7 supplier is an individual or a company that provides 09118300L7 active pharmaceutical ingredient (API) or 09118300L7 finished formulations upon request. The 09118300L7 suppliers may include 09118300L7 API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 09118300L7 Drug Master File in Korea (09118300L7 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 09118300L7. The MFDS reviews the 09118300L7 KDMF as part of the drug registration process and uses the information provided in the 09118300L7 KDMF to evaluate the safety and efficacy of the drug.
After submitting a 09118300L7 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 09118300L7 API can apply through the Korea Drug Master File (KDMF).
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