01 1Alembic Pharmaceuticals Limited
01 1Bosutinib
01 1India
Registration Number : 306MF10032
Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India
Initial Date of Registration : 2024-02-21
Latest Date of Registration : 2024-02-21
A Bosutinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bosutinib, including repackagers and relabelers. The FDA regulates Bosutinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bosutinib 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 Bosutinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bosutinib supplier is an individual or a company that provides Bosutinib active pharmaceutical ingredient (API) or Bosutinib finished formulations upon request. The Bosutinib suppliers may include Bosutinib API manufacturers, exporters, distributors and traders.
click here to find a list of Bosutinib 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 Bosutinib Drug Master File in Japan (Bosutinib JDMF) empowers Bosutinib 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 Bosutinib JDMF during the approval evaluation for pharmaceutical products. At the time of Bosutinib 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 Bosutinib suppliers with JDMF on PharmaCompass.
We have 1 companies offering Bosutinib
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
