Here comes the good news, FDA inspection with zero observations for Casper (link):
We are glad to have completed the audit successfully with Zero observations and at the end
of the inspection no form 483 was issued by USFDA which signifies compliance and
conformance to applicable cGMP regulations says Venkat Jasti, Managing Director of Suven
Pharmaceuticals Limited.
Possible implication is that those 2 filings can move further into commercialization this year while rest of dossier pipeline for 15 filings keep moving as per plan.
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