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