The FDA continues to find issues with Dr. Reddy’s oncology formulation facility in Duvvada, India, one of three facilities cited in a scathing warning letter. The Indian drugmaker said an inspection in September resulted in eight observations.
The acknowledgment (PDF) came in a press release to the Bombay Stock Exchange Tuesday, but it gave no details about the nature of the FDA’s concerns about the facility in Visakhapatnam. The statement said only that the company was addressing the observations.
The FDA in the 2015 warning letter raised a number of issues about the potential for contamination at the facility in the way that employees handled vials. A follow-up inspection in 2017 found more than a dozen issues, some of them repeats.
Dr. Reddy’s has pending ANDAs for generic cancer drugs to be produced at the plant but has been prevented from launching any of them by the FDA citation. The stranglehold by the regulator has taken a toll on Dr. Reddy’s finances, and the Indian drugmaker has responded by selling off some assets and cutting costs.
The drugmaker in October sold its API manufacturing business in Hyderabad to Therapiva, a joint venture of Abu Dhabi-based Neopharma and India’s Laxai Life Sciences, an emerging generics company. No terms were disclosed. In September, Neopharma bought a 390,000-square-foot antibiotic manufacturing plant in Bristol, Tennessee.