In a regulatory filing, the drug maker said the case has been filed in the US District Court for the District of New Jersey.
"The lawsuit alleges the company made materially false and/or misleading statements or omissions in connection with its corporate quality system and specifically in connection with a warning letter from the US Food and Drug Administration dated November 6, 2015 and a letter from the Regierung Von Oberbayern in Germany dated August 10, 2017.
However, the company said it has not yet been served with the lawsuit and cannot comment on the specific allegation except to state "the asserted claims to be without merit".
The Indian drugmaker recently said the German health regulator has not renewed good manufacturing practice (GMP) compliance certificate of its formulations facility 2 in Bachupally in Hyderabad.
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Dr Reddy's officials recently in a press conference said they were expecting re-inspection of Duvvada ( AP) plant while the plant at Srikakulam is awaiting the regulator's response as the inspection was over.
DRL stocks were trading at Rs 2047.95 apiece, down 1.91 per cent over previous close, on BSE at 1415 hrs.
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