01 1Olon SpA
02 1Samhwa Biopharm Co., Ltd.
01 1Sam-O Pharmaceutical Co., Ltd.
02 1Samhwa Biopharm Co., Ltd.
01 2Diethylpropion hydrochloride
01 1Italy
02 1South Korea
Registrant Name : Samhwa Biopharm Co., Ltd.
Registration Date : 2009-06-17
Registration Number : 20090617-97-E-84-02
Manufacturer Name : Samhwa Biopharm Co., Ltd.
Manufacturer Address : 150 Hyeopnyeop-ro, Siheung-si, Gyeonggi-do
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2008-02-05
Registration Number : 20080204-97-E-39-01
Manufacturer Name : Olon SpA
Manufacturer Address : Via Milano, 186 20024 Garbagnate Milanese (MI), Italy
82
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A Dexo Brand of Amfepramone Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexo Brand of Amfepramone Hydrochloride, including repackagers and relabelers. The FDA regulates Dexo Brand of Amfepramone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexo Brand of Amfepramone Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Dexo Brand of Amfepramone Hydrochloride supplier is an individual or a company that provides Dexo Brand of Amfepramone Hydrochloride active pharmaceutical ingredient (API) or Dexo Brand of Amfepramone Hydrochloride finished formulations upon request. The Dexo Brand of Amfepramone Hydrochloride suppliers may include Dexo Brand of Amfepramone Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Dexo Brand of Amfepramone Hydrochloride 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 Dexo Brand of Amfepramone Hydrochloride Drug Master File in Korea (Dexo Brand of Amfepramone Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dexo Brand of Amfepramone Hydrochloride. The MFDS reviews the Dexo Brand of Amfepramone Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Dexo Brand of Amfepramone Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dexo Brand of Amfepramone Hydrochloride 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 Dexo Brand of Amfepramone Hydrochloride API can apply through the Korea Drug Master File (KDMF).
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