01 1M/sMSN Life Sciences Private Limited
02 1M/sSionc Pharmaceuticals Pvt ltd
01 1Gadobutrol Monohydrate IH
02 1Gadobutrol Monohydrate USP/Ph.Eur
01 1WC-0273
02 1WC-0457
01 2India
Gadobutrol Monohydrate USP/Ph.Eur
Date of Issue : 2022-12-09
Valid Till : 2025-12-03
Written Confirmation Number : WC-0457
Address of the Firm : Sy No 544, 545 & 546, Bhiknoor (V), Bhiknoor (M), Kamareddy-503101, Telangana, I...
Date of Issue : 2023-11-15
Valid Till : 2026-05-11
Written Confirmation Number : WC-0273
Address of the Firm : Plot No: 34A, Road No: 1, Jawaharlal Nehru Pharma City, Thanam Village, Parawada...
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PharmaCompass offers a list of Gadobutrol 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 Gadobutrol manufacturer or Gadobutrol supplier for your needs.
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A gadolinium-DO3A-butriol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of gadolinium-DO3A-butriol, including repackagers and relabelers. The FDA regulates gadolinium-DO3A-butriol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. gadolinium-DO3A-butriol 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 gadolinium-DO3A-butriol written confirmation (gadolinium-DO3A-butriol WC) is an official document issued by a regulatory agency to a gadolinium-DO3A-butriol manufacturer, verifying that the manufacturing facility of a gadolinium-DO3A-butriol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting gadolinium-DO3A-butriol APIs or gadolinium-DO3A-butriol finished pharmaceutical products to another nation, regulatory agencies frequently require a gadolinium-DO3A-butriol WC (written confirmation) as part of the regulatory process.
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