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API registration

Being your reliable partner "PROTEK-SVM" is ready to provide assistance in API's registration in the territory of Russian Federation, or make necessary amendments in the present registration in complience with the current legisltion.

The registration procedure assumes that you have a Russian GMP certificate for the manufacturing site. If you do not have the specified document yet, then our specialists are ready to provide you with this service, information about which, you can also find out on our website by checking section "GMP Audit".

For further details on terms and procedure please contact our specialists: +7 (495) 231-28-61, ext. 28-44  or e-mail SV_GRIGOREV@protek.ru.

API product registration workflow (for FDF production in purpose of medical use):

 

API (for FDF production in purpose of medical use) or FDF. Normative documentation update:

Under section 4 of Article 45 of Federal Law of Russian Federation ddt from 12 April 2010 no. 61-FZ 'On Medicinal Drugs Circulation'

Under Act no. 749 ddt from 31 October 2018 Normative documentation for API  must be in complience with  current eddition of State Pharmacopeia of Russian Federation

For further details on terms and procedure please contact our specialists: +7 (495) 231-28-61, ext. 28-44 or e-mail SV_GRIGOREV@protek.ru.

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