US FDA grants Dr Reddy's Labs additional time to respond to warning letter

Indian drugmaker Dr Reddy’s Laboratories (NYSE: RDY) said the US Food and Drug Administration have extended the timeline for replying to the warning letter issued to the company to December 7.

The second-largest drug maker in India said it is in the process of preparing responses to the warning letter issued on November 5 by the US FDA. The company could not immediately be reached for a comment.

The FDA had earlier set a deadline for the company to respond within 15 days from the date of receiving the letter. The warning letter said: “At Dr Reddy’s Laboratories Limited CTO Units VI and V facilities, we identified significant deviations from current good manufacturing practice (cGMP) for the manufacture of active pharmaceutical ingredients (APIs).”