01 1Cambrex Profarmaco Milano Srl
01 1Sam-O Pharmaceutical Co., Ltd.
01 1Glybenclamide
01 1U.S.A
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2022-08-01
Registration Number : 20220801-209-J-1337
Manufacturer Name : Cambrex Profarmaco Milano Sr...
Manufacturer Address : Via Curiel, 34 – 20067 Paullo (Milan) Italy
74
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A GLUCOVANCE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of GLUCOVANCE, including repackagers and relabelers. The FDA regulates GLUCOVANCE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. GLUCOVANCE 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 GLUCOVANCE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A GLUCOVANCE supplier is an individual or a company that provides GLUCOVANCE active pharmaceutical ingredient (API) or GLUCOVANCE finished formulations upon request. The GLUCOVANCE suppliers may include GLUCOVANCE API manufacturers, exporters, distributors and traders.
click here to find a list of GLUCOVANCE 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 GLUCOVANCE Drug Master File in Korea (GLUCOVANCE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of GLUCOVANCE. The MFDS reviews the GLUCOVANCE KDMF as part of the drug registration process and uses the information provided in the GLUCOVANCE KDMF to evaluate the safety and efficacy of the drug.
After submitting a GLUCOVANCE 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 GLUCOVANCE API can apply through the Korea Drug Master File (KDMF).
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