01 1BrightGene Pharmaceutical Co. , Ltd.
02 1CONCORD BIOTECH LIMITED.
01 2Everolimus
01 1China
02 1India
Registration Number : 230MF10023
Registrant's Address : Building C25-C28, No. 218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China...
Initial Date of Registration : 2018-02-14
Latest Date of Registration : 2018-10-23
Registration Number : 230MF10031
Registrant's Address : 1482-1486, Trasad Road, Dholka, Dist. Ahmedabad-382225, Gujarat, INDIA
Initial Date of Registration : 2018-02-19
Latest Date of Registration : 2018-02-19
A Everolimus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Everolimus, including repackagers and relabelers. The FDA regulates Everolimus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Everolimus 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 Everolimus manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Everolimus supplier is an individual or a company that provides Everolimus active pharmaceutical ingredient (API) or Everolimus finished formulations upon request. The Everolimus suppliers may include Everolimus API manufacturers, exporters, distributors and traders.
click here to find a list of Everolimus 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 Everolimus Drug Master File in Japan (Everolimus JDMF) empowers Everolimus 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 Everolimus JDMF during the approval evaluation for pharmaceutical products. At the time of Everolimus 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 Everolimus suppliers with JDMF on PharmaCompass.
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