India’s Sun Pharma has regained its financial footing but the plant in Halol, India, that was at the heart of many of its earlier issues continues to present a few nagging problems.
According to the most recent FDA Enforcement Report, Sun is recalling 16,085 bottles of the antidepressant bupropion hydrochloride extended-release tablets manufactured at the Halol plant because they failed specifications for dissolution. The recall, which began in June, was classified this week by the FDA.
The plant is one of Sun's primary facilities for providing products to the U.S. so Sun saw sales slip after the FDA cited its Halol plant with a Form 483 in 2014. The agency issued a warning letter to the plant last December for a host of quality and data integrity issues and the drugmaker recalled a number of products as a result.
Those issues took a toll on Sun for awhile. At the end of 2015, it reported that for the first 9 months of the year, its sales in the U.S. were down 15% to $1.48 billion. But the next quarter, Sun had turned the corner, reporting sales in the U.S. of $580 million, up 19% over same period the previous year. They were boosted by sales of a generic of leukemia drug Gleevec, for which Sun had a 180-day exclusivity.
Meanwhile, Sun also has been paring down its manufacturing operations after closing on its $4 billion buyout last year of Ranbaxy Laboratories. In June it reported it would sell plants in Philadelphia, PA, and Aurora, IL, to Frontida BioPharm. Frontida, owned by a group of investors, is a newly formed CDMO that is an affiliate company to Frontage Laboratories. Frontage is a long-standing CRO in Pennsylvania, New Jersey and China that is controlled by Chinese CRO Hangzhou Tigermed.
- access the recall here