Sun Pharmaceutical Industries Ltd. said it had addressed issued raised by the U.S. Food and Drug Administration at its main manufacturing facility responsible for new product launches in America.
India's largest drugmaker can now resume shipments from the Halol facility in Gujarat, which contributed 15% of the company's revenues in 2015, according to Reuters.
Most of the India-based generics drugmaker's new products for the U.S. are launched from the Halol plant, but the launches were stopped after the company received a warning in 2015 for violating manufacturing standards.
The company said it had received a so-called establishment inspection report from the regulator indicating that issues contained in its warning letter had been addressed.
During an earnings call last year, the company's founder and managing director said bringing the facility back in compliance was the company's top priority. The plant had repeatedly failed to pass FDA inspections, leaving investors unhappy.