01 1Cambrex Profarmaco Milano Srl
01 1Samoh Pharmaceutical Co., Ltd.
01 1Glibenclamide
01 1U.S.A
Registrant Name : Samoh 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
A Glyburide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glyburide, including repackagers and relabelers. The FDA regulates Glyburide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glyburide 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 Glyburide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glyburide supplier is an individual or a company that provides Glyburide active pharmaceutical ingredient (API) or Glyburide finished formulations upon request. The Glyburide suppliers may include Glyburide API manufacturers, exporters, distributors and traders.
click here to find a list of Glyburide 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 Glyburide Drug Master File in Korea (Glyburide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Glyburide. The MFDS reviews the Glyburide KDMF as part of the drug registration process and uses the information provided in the Glyburide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Glyburide 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 Glyburide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Glyburide suppliers with KDMF on PharmaCompass.
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