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 Nexavar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nexavar, including repackagers and relabelers. The FDA regulates Nexavar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nexavar 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 Nexavar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nexavar supplier is an individual or a company that provides Nexavar active pharmaceutical ingredient (API) or Nexavar finished formulations upon request. The Nexavar suppliers may include Nexavar API manufacturers, exporters, distributors and traders.
click here to find a list of Nexavar 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 Nexavar Drug Master File in Japan (Nexavar JDMF) empowers Nexavar 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 Nexavar JDMF during the approval evaluation for pharmaceutical products. At the time of Nexavar 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 Nexavar suppliers with JDMF on PharmaCompass.
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