Sun Pharmaceutical Industries Ltd.

Sun Pharmaceutical Industries’ manufacturing facility in Halol in Gujarat is undergoing a surprise audit by the US Food and Drug Administration (US FDA). The move may have been triggered by a number of recent recalls from the plant. The plant contributes to around 40% of US sales and around 25% of consolidated profit of the company.

Earlier in May, the company’s another manufacturing facility in Karkhadi, also in Gujarat, had received a warning letter from the US FDA after investigators identified violations of current good manufacturing practice and regulations for finished pharmaceuticals.

Sun Pharmaceutical Industries is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world.