01 1Hetero Labs Limited
02 1Jiangsu Xidi Pharmaceuticals Co. , Ltd.
01 1Nilotinib hydrochloride dihydrate "D"
02 1nilotinib hydrochloride dihydrate
01 1China
02 1India
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
Nilotinib hydrochloride dihydrate "D"
Registration Number : 307MF10111
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...
Initial Date of Registration : 2025-08-28
Latest Date of Registration : 2025-08-28
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PharmaCompass offers a list of Nilotinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Nilotinib manufacturer or Nilotinib supplier for your needs.
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PharmaCompass also assists you with knowing the Nilotinib API Price utilized in the formulation of products. Nilotinib API Price is not always fixed or binding as the Nilotinib Price is obtained through a variety of data sources. The Nilotinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A nilotinib hydrochloride sesquihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of nilotinib hydrochloride sesquihydrate, including repackagers and relabelers. The FDA regulates nilotinib hydrochloride sesquihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. nilotinib hydrochloride sesquihydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A nilotinib hydrochloride sesquihydrate supplier is an individual or a company that provides nilotinib hydrochloride sesquihydrate active pharmaceutical ingredient (API) or nilotinib hydrochloride sesquihydrate finished formulations upon request. The nilotinib hydrochloride sesquihydrate suppliers may include nilotinib hydrochloride sesquihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of nilotinib hydrochloride sesquihydrate 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 sesquihydrate Drug Master File in Japan (nilotinib hydrochloride sesquihydrate JDMF) empowers nilotinib hydrochloride sesquihydrate 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 sesquihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of nilotinib hydrochloride sesquihydrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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