Dr Reddy’s had, a day earlier, intervened in a lawsuit, inclining towards the FDA and against another domestic generic drug maker, Ranbaxy. The latter had sued the regulator for revoking the key exclusivity period of two of its major drugs in the US market, Nexium and Valcyte. Dr. Reddy’s was granted a nod to launch the Valcyte generic after the revocation order for Ranbaxy.
Dr. Reddy’s shares closed almost three per cent higher on Wednesday at Rs 3,514.85 on the BSE.
The FDA has been tightening its monitoring of Indian pharma majors over compliance issues. Surprise plant inspections and import alerts have been frequent outcomes.
In September, it made an unannounced inspection at Sun Pharmaceutical Industries’ Halol unit. In May, another manufacturing unit of Sun Pharma, at Karkhadi, also in Gujarat, got a warning letter from the FDA after investigators identified violations of current good manufacturing practices and regulations for finished pharmaceuticals.
Of late, Indian drug makers have been facing stringent enforcements in the US, the world’s largest pharma market. Several manufacturing plants of leading domestic companies
— including Ranbaxy, Sun Pharma, Wockhardt and Strides Arcolab — have come under the FDA’s scanner on compliance issues. The frequency of regulatory inspections has risen significantly in recent years.