01 1Shanghai Desano Chemical Pharmaceutical Co. , Ltd.
01 1Lumefantrine
01 1China
Registration Number : 306MF10034
Registrant's Address : No. 1479, Zhangheng Road, Zhengjiang High Tech Park, Shanghai 201203, China
Initial Date of Registration : 2024-02-29
Latest Date of Registration : 2024-02-29
A Lumefantrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lumefantrine, including repackagers and relabelers. The FDA regulates Lumefantrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lumefantrine 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 Lumefantrine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lumefantrine supplier is an individual or a company that provides Lumefantrine active pharmaceutical ingredient (API) or Lumefantrine finished formulations upon request. The Lumefantrine suppliers may include Lumefantrine API manufacturers, exporters, distributors and traders.
click here to find a list of Lumefantrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Lumefantrine Drug Master File in Japan (Lumefantrine JDMF) empowers Lumefantrine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Lumefantrine JDMF during the approval evaluation for pharmaceutical products. At the time of Lumefantrine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Lumefantrine suppliers with JDMF on PharmaCompass.
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