Sun Pharmaceutical’s US subsidiary, Caraco Pharmaceuticals, has received a warning letter from the US Food and Drug Administration (USFDA) over quality-control issues. The letter, which was issued on Friday, was a follow-up to the FDA inspection of Caraco’s manufacturing facility in Detroit in May.
The FDA may withhold approval of pending new drug applications of Caraco till the company satisfies the authority’s concerns. Caraco intends to respond to the FDA within 15 days. The company’s Detroit facility manufactures generic drugs. This development does not affect Sun’s sales or approvals for ANDAs in the US. It also does not affect sales for Caraco but might cause a slowdown in approvals for it.
A section of the domestic industry finds a design in Indian companies being penalised in the US market. Recently, USFDA had banned drugs which were produced at Ranbaxy’s two manufacturing plants in India.