The recent guidance from the US Food & Drug Administration (USFDA) on complex generics is expected to provide more clarity to US-focused Indian pharmaceutical formulators in preparing and submitting abbreviated new drug applications (ANDAs), says a report. This will help domestic pharma formulators with pending ANDA approvals to reduce review cycles and expedite approvals, says a weekend report by India Ratings. The current guidance dated October 9 is specific to complex transdermal and topical products. The agency in its mid-year FY19 pharma outlook had identified the lack of scientific and regulatory clarity about complex drugs as one of the key hurdles for approvals of complex products. Indian pharmaceutical formulators have indicated low double-digit pricing erosion for their base portfolio at end-FY18 and were exiting highly generic commercially unviable products and pruning R&D pipeline. The regulatory clarity will benefit formulators such as Lupin ...
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