India’s Dr. Reddy’s Laboratories, which has been whiplashed repeatedly by FDA actions against its plants, saw its sales in the U.S. fall markedly in the last fiscal year.
The company reported (PDF) that revenues in North America were off 16% to 63.6 billion rupees ($993 million). It ascribed some of the fall to increased competition to a key drug in the market but it also acknowledged that the FDA's problems with its manufacturing had again taken a toll.
“FY17 has been a challenging year due to lack of new product approvals for the U.S. market.... We will continue our focus on rationalization of cost structures and building a sustainable quality culture across the organization,” CEO GV Prasad said in a statement.
Globally, Dr. Reddy’s FY 2017 revenues were down 9% to 140.8 billion rupees ($2.2 billion) and its earnings per share were down 38% to $1.11 a share.
The drugmaker has struggled in the market since FDA concerns at its plants in India resulted in a three-facility warning letter in 2015 and impeded its ability to launch new drugs in the U.S. The FDA in recent months has re-inspected two of the facilities and uncovered more problems.
The agency has gone on to take a close look at other Dr. Reddy’s plants. Last month, the Indian drugmaker said an inspection of its formulation plant in Bachupally in Hyderabad resulted in a Form 483 with 11 observations.