01 1Chongqing Huapont Shengchem Pharmaceutical Co., Ltd
01 1Ace Biopharm Co., Ltd.
01 1Calcipotriol hydrate
01 1China
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2020-07-02
Registration Number : 20200702-211-J-456
Manufacturer Name : Chongqing Huapont Shengchem ...
Manufacturer Address : No. 666 Rongjun Road, Nanjin Avenue Hechuan District, Chongqing China
31
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A Sorilux manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sorilux, including repackagers and relabelers. The FDA regulates Sorilux manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sorilux 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 Sorilux manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sorilux supplier is an individual or a company that provides Sorilux active pharmaceutical ingredient (API) or Sorilux finished formulations upon request. The Sorilux suppliers may include Sorilux API manufacturers, exporters, distributors and traders.
click here to find a list of Sorilux 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 Sorilux Drug Master File in Korea (Sorilux KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sorilux. The MFDS reviews the Sorilux KDMF as part of the drug registration process and uses the information provided in the Sorilux KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sorilux 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 Sorilux API can apply through the Korea Drug Master File (KDMF).
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