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