Dr. Reddy’s Bachupally plant has a version of FDA deja vu

A Dr. Reddy’s formulation plant in India appears stuck on regulatory repeat. The drugmaker reported that the FDA had completed an inspection of the facility in Bachupally and cited it with 11 violations. When the FDA inspected the plant in 2017 it was cited with—you've got it—11 violations.

In a filing (pdf) Friday with the Bombay Stock Exchange, Dr. Reddy’s did not hint at the nature of the observations, simply saying that it will address the violations at its Formulations Manufacturing Plant - 3 at Bachupally, Hyderabad, "comprehensively within the stipulated timeline.”

In 2017, the Indian company claimed that the observations were mostly procedural, “reflecting the need to improve people capabilities and strengthen documentation and laboratory systems.” Later that year, it reported the FDA had cleared the plant in an establishment inspection report.

The company’s extensive manufacturing network has stacked up quite a few FDA citations in recent years. Last September, the agency issued eight observations to Dr. Reddy’s oncology formulation facility in Duvvada, India. It is one of three facilities cited in a scathing warning letter in 2015 that raised issues about the potential for contamination. A follow-up inspection of that facility two years later found more than a dozen issues, some of them repeats.

While the regulatory problems have created some drag on the company’s finances, it recently reported (PDF) that revenues for the quarter ended Dec. 31, 2018, were up slightly at $553 million. Sales in North America, where the entire generics market has been soft for several years, were down 8% to $14.8 million. North American sales account for nearly 40% of Dr. Reddy’s revenues. Sales in emerging markets, which account for about 20% of its revenues, were up 31% to $7.7 million.

Feb 11, 2019

https://www.fiercepharma.com/