01 1Sinopharm Weiqida Pharmaceutical Co., Ltd.
01 1Masung LS Co., Ltd.
01 1Amoxicillin trihydrate potassium clavulanate
01 1China
Amoxicillin trihydrate potassium clavulanate
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2025-04-21
Registration Number : 20250421-30-A-393-26
Manufacturer Name : Sinopharm Weiqida Pharmaceut...
Manufacturer Address : High-tech Industrial Zone, Economic & Technological Development Zone, Datong, Shanxi
70
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A Amoclan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amoclan, including repackagers and relabelers. The FDA regulates Amoclan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amoclan 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 Amoclan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Amoclan supplier is an individual or a company that provides Amoclan active pharmaceutical ingredient (API) or Amoclan finished formulations upon request. The Amoclan suppliers may include Amoclan API manufacturers, exporters, distributors and traders.
click here to find a list of Amoclan 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 Amoclan Drug Master File in Korea (Amoclan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Amoclan. The MFDS reviews the Amoclan KDMF as part of the drug registration process and uses the information provided in the Amoclan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Amoclan 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 Amoclan API can apply through the Korea Drug Master File (KDMF).
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