Dr Reddy's Labs gets USFDA EIR for Srikakulam formulations plant

Hyderabad: Dr. Reddy's Laboratories Ltd on Wednesday said it has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its formulations plant located in a Special Economic Zone at Srikakulam in Andhra Pradesh.

".. with regard to the audit of our Formulations Srikakulum Plant (SEZ) Unit I, Andhra Pradesh, we would like to inform you that we have received the Establishment Inspection Report from US FDA..," Dr. Reddy''s said in a disclosure.

The report indicates closure of the audit and the inspection classification of the facility was determined as "No Action Indicated" (NAI).

The drugmaker on May 8 said it received the EIR from US FDA, for its API manufacturing plant at Srikakulam, (CTO VI) indicating closure of the audit, and the inspection classification of this facility was determined as "Voluntary Action Indicated" (VAI).

The site was issued a warning letter in November 2015 after the inspection in 2014 and was under the "Official Action Indicated" classification.

Dr. Reddy's Laboratories Ltd. is an integrated pharmaceutical company headquartered in Hyderabad, committed to providing affordable and innovative medicines for healthier lives.

Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology.

The Company's markets include – USA, India, Russia & CIS countries, and Europe.

Read also: Dr Reddy's recalls 1,752 bottles of Esomeprazole Magnesium delayed-release capsules in US