The warning letter was shot off after the USFDA conducted a review of Sun Pharma's initial response to the issues raised during inspection of the facility in November last year. "...it lacks sufficient corrective actions. We also acknowledge receipt of your firm's additional correspondence dated January 28, 2014, and March 11, 2014," the USFDA said. In March this year, the health regulator had banned the import of drugs from the Karkhadi facility for violation of manufacturing norms. USFDA said its investigators observed specific deviations during the inspection of the API manufacturing facility, including "failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards."
The health regulator pointed out "failure to assign and identify raw materials with a distinctive code, batch, or receipt number, and to identify the disposition of materials" at the Kharkhadi facility. Mumbai-based Sun Pharma's Karkhadi facility manufactures antibiotics and active pharmaceutical ingredients (APIs). The company, which is acquiring Ranbaxy Laboratories, has 10 manufacturing sites in India. Sun Pharma shares closed at Rs 587.30 on the BSE, up 0.63 per cent.
Sun Pharma stock price On May 20, 2014, Sun Pharmaceutical Industries closed at Rs 587.30, up Rs 3.70, or 0.63 percent. The 52-week high of the share was Rs 653.10 and the 52-week low was Rs 458.00. The company's trailing 12-month (TTM) EPS was at Rs 0.95 per share as per the quarter ended December 2013. The stock's price-to-earnings (P/E) ratio was 618.21. The latest book value of the company is Rs 41.64 per share. At current value, the price-to-book value of the company is 14.10.