MUMBAIDr Reddy’s Laboratories Ltd, India’s second-largest drugmaker, has received a “warning letter” from USA regulators over inadequate quality controls at three manufacturing plants producing drugs for cancer and other diseases.
Advertisement
Leading pharmaceutical company Dr Reddy’s Laboratories have received warning letter from the United States drug regulator over quality issues at three of its key Indian facilities manufacturing pharmaceutical raw material and oncology medicines. The three units contribute almost 10-12% of the total sales of the company and have potential to impact not only the overall financial performance of the drug maker but also damage reputation in the global market.
At NSE, shares of the company dived 14.56 per cent to settle at Rs 3,630.65.
Dr. Reddy’s has faced delays in approvals for US products this year, including a generic version AstraZeneca Plc’s heartburn drug Nexium.
In the BSE filing, company said “This action follows earlier inspections of these sites by the agency in November 2014, January and February 2015, respectively”. Such letters are issued by the agency when it finds a manufacturer has “significantly violated” its regulations. Dr. Reddy’s had transferred the technology for manufacturing the bulk ingredient for Nexium to another site, Chief Operating Officer Abhijit Mukherjee said in an interview in March.
But analysts say the FDA considers data integrity issues to be the most serious, typically requiring at least two years to be remedied to its satisfaction. GV Prasad, CEO, Dr Reddy’s Lab said, “We have embarked on an initiative to revamp our quality systems and processes as an organisation-wide process”.
Advertisement
The FDA last November issued a Form 483, an inspection report detailing possible violations of the Food Drug and Cosmetic Act, for the Srikakulam plant.
