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