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Re: jbog post# 12346

Sunday, 11/13/2016 11:35:14 AM

Sunday, November 13, 2016 11:35:14 AM

Post# of 20689
RDY acknowledges 20mg-Copaxone CRL and discusses planned response to the CRL on 3Q16 CC:

https://t.co/VdIDkqR6qr (page 13)

…Copaxone 20 mg, the validation batches are complete, it looks good. Compilation of the response is going on, we are behind schedule by a couple of weeks…because the amount of analytical data to be generated is fairly heavy.

…by let us say by second week of next month we should respond back on the DMF [drug master file] and this is the same DMF for 40 mg.

h/t ‘@chiragontwtr’.

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