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