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