01 1Huvepharma Italia s. r. l.
01 1Artemether
01 1Italy
Registration Number : 306MF10012
Registrant's Address : ViaR. Lepetit, 142-12075 Garesio (CN) ITALY
Initial Date of Registration : 2024-01-17
Latest Date of Registration : 2024-01-17
A Artemether manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Artemether, including repackagers and relabelers. The FDA regulates Artemether manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Artemether 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 Artemether manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Artemether supplier is an individual or a company that provides Artemether active pharmaceutical ingredient (API) or Artemether finished formulations upon request. The Artemether suppliers may include Artemether API manufacturers, exporters, distributors and traders.
click here to find a list of Artemether 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 Artemether Drug Master File in Japan (Artemether JDMF) empowers Artemether 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 Artemether JDMF during the approval evaluation for pharmaceutical products. At the time of Artemether 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 Artemether suppliers with JDMF on PharmaCompass.
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