Mumbai: The US Food and Drug Administration (FDA) has made 13 observations relating to deviation from good manufacturing practices at Dr.Reddy’s Laboratories Ltd’s cancer formulations facility at Duvvada in Visakhapatnam, the company said in a stock exchange filing on Wednesday.
“The audit of our formulation manufacturing plant at Duvvada, Visakhapatnam, by the USFDA, has been completed today (8 March, 2017). We have been issued a Form-483 with 13 observations, which we are addressing,” the company said.
Dr.Reddy’s did not give details on nature of the observations.
The FDA issues a Form-483 if its investigators spot any conditions that in their judgment may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related laws.
“This is a negative development as the number of observations is high despite the remedial measures taken by Dr.Reddy’s after receiving the warning letter. Duvvada plant is newer but USFDA is very strict as far as injectables are concerned. I believe that remediation process will take at least one to one-and-a-half years and this will impact future product filings and approvals in the US,” said Surajit Pal, an analyst at Prabhudas Lilladher.
On 21 February, the company’s active pharmaceutical ingredients (API) manufacturing plant at Miryalaguda in Telangana was issued a Form-483 by the USFDA with three observations relating to violation of norms.
In November 2015, the Hyderabad-based drug maker had received warning letter from the USFDA for breach of norms at formulation plant at Duvvada, and API facilities at Miryalaguda and Srikakulam.
In mid-January, Dr.Reddy’s had said that “all the commitments as part of warning letter response have been completed and the three plants will be re-inspected by the US regulator by end of March.”
After receiving the warning letter, the pharmaceutical major submitted five responses to the USFDA at regular intervals, giving updates on the remedial work undertaken at the three plants. The company also hired an independent consultant to resolve the compliance issues at these units.
The warning letter had an adverse impact on the company’s earnings as new product approvals in the US from these sites were put on hold. The US market accounted for nearly half of Dr.Reddy’s total revenue of Rs15,470 crore in the year ended March 2016.
On Wednesday, shares of Dr.Reddy’s fell 0.04% to Rs2,851.40 on BSE, while the benchmark Sensex shed 0.34% to 28,901.94 points.