Manufacturing Woes Continue To Plague Dr Reddy’s; Are Generic Gleevec Launch Plans Under Threat?
Dr Reddy’s Laboratories was battered on Indian bourses on March 9 after one of the firm’s formulation sites failed to get a clean chit from the FDA, piling up pressure on important US generic launch timelines.
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India’s biggest drug-maker, Sun Pharmaceutical Industries Ltd., has reported a more than tripling of its quarterly profit thanks to US sales of a generic version of Novartis AG’s leukemia blockbuster Gleevec. But now its 180-day sales exclusivity window has closed and generic rivals are launching in the US market, pushing prices down.
Dr. Reddy’s Laboratories (DRL) has reported a slump in profits for the first quarter, dented by a decline in volume growth and pricing pressure in the US as well as a loss of business in Venezuela. While the firm's long term story appears intact, resolution of compliance issues at its Indian sites and product flows in the US and other markets (DRL expects to participate in a Russian tender for rituximab) could lift investor sentiment significantly.
Dr Reddy's Laboratories was bludgeoned on Indian bourses after the firm said that it had received FDA warning letters at three manufacturing sites, including an oncology plant, in India.