01 1Jiangsu Xidi Pharmaceuticals Co. , Ltd.
01 1nilotinib hydrochloride dihydrate
01 1China
Nilotinib hydrochloride dihydrate
Registration Number : 306MF10116
Registrant's Address : No. 3 Jiangfeng road, Life and Health Industrial Park, Qidong City 226200, Jiangsu Pr...
Initial Date of Registration : 2024-08-22
Latest Date of Registration : 2024-08-22
A Tasigna manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tasigna, including repackagers and relabelers. The FDA regulates Tasigna manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tasigna 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 Tasigna manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tasigna supplier is an individual or a company that provides Tasigna active pharmaceutical ingredient (API) or Tasigna finished formulations upon request. The Tasigna suppliers may include Tasigna API manufacturers, exporters, distributors and traders.
click here to find a list of Tasigna 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 Tasigna Drug Master File in Japan (Tasigna JDMF) empowers Tasigna 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 Tasigna JDMF during the approval evaluation for pharmaceutical products. At the time of Tasigna 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 Tasigna suppliers with JDMF on PharmaCompass.
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