Indian pharma cos with bigger US presence face more FDA scrutiny: Analysts

Big entities such as Aurobindo and Dr Reddy's have been currently filing for new product approvals from multiple sites

Higher exposure to the American market and their constant product filings are among reasons why the bigger Indian pharmaceutical companies are in constant regulatory focus compared to smaller peers, say analysts.

The shortfall or deviations noted by inspectors of the US sector regulator, the Food and Drugs Administration (FDA), at manufacturing facilities in Hyderabad have often caused a slowing of new drug filings or launches in that market.’

Dr Reddy’s Laboratories was the first Indian pharma player to secure FDA approval for a US factory, in the late 1980s, when it set out to export Active Pharmaceutical Ingredients (APIs) there. Yet, after