India’s largest drugmaker, Sun Pharmaceutical Industries, plans to ask U.S. regulators by the middle of this year to re-inspect a plant in Gujarat after they criticised manufacturing standards there, Sun’s founder said.
Dilip Shanghvi said the company would ask the U.S. Food and Drug Administration (FDA) for the new inspection of the Halol plant in Gujarat in the first quarter of the company’s next fiscal year, which runs from April to June 2016, by which time the company hopes to have addressed the FDA’s concerns.
The world’s fifth-largest generic drugmaker also said it had agreed with New Jersey-based Merck & Co Inc to call off their joint venture, struck in 2011 to develop branded generics for emerging markets, due to “changes in priorities” of both companies.
