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 Tris Buffer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tris Buffer, including repackagers and relabelers. The FDA regulates Tris Buffer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tris Buffer 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 Tris Buffer supplier is an individual or a company that provides Tris Buffer active pharmaceutical ingredient (API) or Tris Buffer finished formulations upon request. The Tris Buffer suppliers may include Tris Buffer 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 Tris Buffer Drug Master File in Korea (Tris Buffer KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tris Buffer. The MFDS reviews the Tris Buffer KDMF as part of the drug registration process and uses the information provided in the Tris Buffer KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tris Buffer 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 Tris Buffer API can apply through the Korea Drug Master File (KDMF).
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