Dr. Reddy’s said the US Food and Drug Administration (FDA) had issued it with a Form 483 detailing 11 observations after an inspection of its Plant 3 formulations facility in Bachupally, Telangana last month.
The firm said the observations “are mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems,” but did not give specific details when contacted by in-Pharmatechnologist.com.
A spokeswoman told us the site "is an oral solid drug manufacturing facility" adding "there is no stoppage of production required or envisaged at this point in time."
Three other Dr Reddy’s plants - its active pharmaceutical ingredient (API) facilities in Miryalaguda, Duvvada and Srikakulam – have been issued with Form 483s this year.
US generics business
Dr Reddy’s generic drug business – which is supplied by products formulated at the Plant 3 facility – has seen revenue generated in North America decline.
According to the firm’s Q3 report non-branded drugs generated revenue of INR16.6bn ($259m) in North America for the three months ended December 31, 2016 down 15% on the year-earlier quarter.
Dr. Reddy’s attributed the decline to increased competition for its version of Roche’s antiviral Valcyt (valgancyclovir) and pricing pressure for its injectable drug products.
The firm is due to report its results for fiscal 2017 on May 12.