01 1Samhwa Biopharm Co., Ltd.
01 1Samhwa Biopharm Co., Ltd.
01 1Sobreroll
01 1South Korea
Registrant Name : Samhwa Biopharm Co., Ltd.
Registration Date : 2021-11-30
Registration Number : 20211130-211-J-1164
Manufacturer Name : Samhwa Biopharm Co., Ltd.
Manufacturer Address : 150 Hyeop-ro, Siheung-si, Gyeonggi-do
A Soberol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Soberol, including repackagers and relabelers. The FDA regulates Soberol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Soberol 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 Soberol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Soberol supplier is an individual or a company that provides Soberol active pharmaceutical ingredient (API) or Soberol finished formulations upon request. The Soberol suppliers may include Soberol API manufacturers, exporters, distributors and traders.
click here to find a list of Soberol 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 Soberol Drug Master File in Korea (Soberol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Soberol. The MFDS reviews the Soberol KDMF as part of the drug registration process and uses the information provided in the Soberol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Soberol 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 Soberol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Soberol suppliers with KDMF on PharmaCompass.
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