Monday, September 27, 2010

When we are licenced to create simvastatin -usp, can we supply any pharmaceutical title.?

Can we supply the material as per usp 24 to a customer as per their requirement when , existing is usp-28.
The engineering licence was issued for "Simvastatin-USP" next to reffering any pharmacopoeial specifications. Try reading the terms of the license, that should answer your give somebody the third degree.
I do not think you can. Your license must be for produce Simvastin-usp only and surrounded by the license itself they would have given adjectives manufacturing specifications and you are irrelevant to deviate that. If you do anything other than the specifications within the license or supply as raw stuff and if it comes to the notice of authorities they may nullify the license. So you cannot supply the material to anyone.

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