USFDA to re-inspect Dr Reddy's plants by March

The company received a warning letter from the USFDA on November 5, 2015, for specific violations

The US Food and Drug Administration (FDA) will re-inspect three manufacturing units of Dr Reddy's Laboratories at Nalgonda (in Telangana), Srikakulam and Visakhapatnam (in Andhra Pradesh) in this quarter, the company said in a statement.

The Hyderabad-based drug manufacturer had received a warning letter from the USFDA on November 5, 2015, for specific deviations and violations from current good manufacturing practices (cGMP) at three manufacturing units. Later, the company had taken remedial measures and submitted five responses to the USFDA till August 2016.

Leading global consultancy firm Lachman Consulting Services performed independent product quality assessments and all the commitments as part of the response to the warning letter have been completed at three manufacturing facilities, the company informed.

Dr Reddy's revenues from the US was affected following the warning letter as the number of new launches in the US market were very limited since then. The US market contributes to almost half of its overall business.

Currently, Dr Reddy's has 83 pending abbreviated new drug applications (ANDAs) and two pending NDAs at the USFDA. The company plans to launch speciality products and differentiated proprietary products in the US and other regulated markets.