01 1MSN Laboratories Private Limited.
01 1Bosutinib Monohydrate [Form I] (BV)
01 1India
Bosutinib Monohydrate [Form I] (BV)
Registration Number : 307MF10038
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2025-02-26
Latest Date of Registration : 2025-02-26
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PharmaCompass offers a list of Bosutinib Monohydrate 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 Bosutinib Monohydrate manufacturer or Bosutinib Monohydrate supplier for your needs.
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A Bosutinib Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bosutinib Monohydrate, including repackagers and relabelers. The FDA regulates Bosutinib Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bosutinib 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.
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A Bosutinib Monohydrate supplier is an individual or a company that provides Bosutinib Monohydrate active pharmaceutical ingredient (API) or Bosutinib Monohydrate finished formulations upon request. The Bosutinib Monohydrate suppliers may include Bosutinib Monohydrate API manufacturers, exporters, distributors and traders.
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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 Monohydrate Drug Master File in Japan (Bosutinib Monohydrate JDMF) empowers Bosutinib 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 Bosutinib Monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Bosutinib Monohydrate 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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