One of the top Indian generic drug companies with major exposure to U.S market, Dr Reddys gets USFDA clearance for its injectables manufacturing facility at Duvvada in Visakhapatnam from all the adverse observations.
New Delhi: In a major relief to drug major Dr Reddy’s Lab, the United States Food and Drug Administration (USFDA) has lifted the warning letter issued to its injectables manufacturing facility at Duvvada in Visakhapatnam. The company recently said it has received the inspection closure report for the facility from the US health regulator.
Thirty nine months ago it was issued a warning letter along with two of the company’s active ingredient (API) plants in November 2015.
Drug major Dr Reddy’s Laboratories Saturday said it has received the inspection closure report for its Duvvada facility in Andhra Pradesh from the US health regulator.
“We have received a written communication from the United States Food and Drug Administration (USFDA) about the issuance of establishment inspection report (EIR) for FTO VII, our formulations manufacturing facility at Duvvada, Visakhapatnam,” Dr Reddy’s said in a filing to the BSE.
This site was included in the warning letter received from USFDA in November 2015. Subsequently, the site was audited by the regulator in March 2017 for which we received EIR in November 2017, wherein the site’s status remained unchanged, it added. The site was again audited in October 2018, Dr Reddy’s said.
“Based on our responses and follow-up actions, the USFDA has concluded that this inspection is ‘closed’ and has determined the inspection classification of this facility as voluntary action initiated,” it added.
Duvvada formulations unit has been a central manufacturing facility for Dr Reddy’s, dedicated to the crucial Oncology injectables.
Duvvada is the second plant to come out of the warning letter after multiple inspections conducted by the US drug regulator. Prior to this, in June 2017 the API facility in Miryalaguda was issued Establishment Inspection Report (EIR), clearing the facility from all the compliance issues.