01 1Hetero Labs Limited
01 1Sorafenib tosylate [D]
01 1India
Registration Number : 230MF10114
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...
Initial Date of Registration : 2018-08-22
Latest Date of Registration : 2018-08-22
A Sorafenib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sorafenib, including repackagers and relabelers. The FDA regulates Sorafenib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sorafenib 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 Sorafenib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sorafenib supplier is an individual or a company that provides Sorafenib active pharmaceutical ingredient (API) or Sorafenib finished formulations upon request. The Sorafenib suppliers may include Sorafenib API manufacturers, exporters, distributors and traders.
click here to find a list of Sorafenib 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 Sorafenib Drug Master File in Japan (Sorafenib JDMF) empowers Sorafenib 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 Sorafenib JDMF during the approval evaluation for pharmaceutical products. At the time of Sorafenib 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 Sorafenib suppliers with JDMF on PharmaCompass.
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