01 1Samoh Pharmaceutical Co., Ltd.
01 1Samoh Pharmaceutical Co., Ltd.
01 1Pelubiprofentromethamine (micronized)
01 1Uzbekistan
Pelubiprofentromethamine (micronized)
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-08-05
Registration Number : 2105-44-ND
Manufacturer Name : Samoh Pharmaceutical Co., Lt...
Manufacturer Address : 63, Okgucheonseo-ro 81beon-gil, Siheung-si, Gyeonggi-do (705, 1st floor, Sihwa Indust...
85
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A 04577_FLUKA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 04577_FLUKA, including repackagers and relabelers. The FDA regulates 04577_FLUKA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 04577_FLUKA 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 04577_FLUKA supplier is an individual or a company that provides 04577_FLUKA active pharmaceutical ingredient (API) or 04577_FLUKA finished formulations upon request. The 04577_FLUKA suppliers may include 04577_FLUKA 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 04577_FLUKA Drug Master File in Korea (04577_FLUKA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 04577_FLUKA. The MFDS reviews the 04577_FLUKA KDMF as part of the drug registration process and uses the information provided in the 04577_FLUKA KDMF to evaluate the safety and efficacy of the drug.
After submitting a 04577_FLUKA 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 04577_FLUKA API can apply through the Korea Drug Master File (KDMF).
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