The Indian company did not release many details regarding the US Food and Drug Administration (FDA)’s findings, only noting that the Hyderabad-based manufacturing plant received 11 observations.
The company stated, “We will address [the observations] comprehensively within the stipulated timeline.”
This is the second time that the formulation manufacturing plant has seen FDA regulatory action at the facility, after it was issued a Form 483 in May 2017. During the previous inspection that resulted in a Form 483, the agency also found 11 observations, which the company told us, at the time, were ‘mostly procedural’.
The Hyderabad site houses three formulation plants, the most recent inspection relates to ‘plant 3’; the space that also holds the company’s global office, as well as three active pharmaceutical ingredient (API) manufacturing facilities and four R&D sites.
Problems at the site also extended to an API plant, which was issued a Form 483 in March 2018.
Six months ago, the company sold an API plant to the generic joint venture, Therapiva. The company noted the decision to sell was to streamline its business to ‘optimise’ global costs.
Shares in Dr. Reddy’s dipped 4% on the news, dropping from ₹2776 ($39.31) on the release of the news to ₹2663 ($37.71), as of the time of reporting.