Drug maker Dr Reddy’s on October 8 said it got Form 483 with 8 observations from US FDA for its injectable plant in Duvvada.
“This is to inform you that the audit of our formulations manufacturing facility at Duvvada, Visakhapatnam, by the US FDA, has been completed today,” the company said in a statement to stock exchanges.
“We have been issued a Form 483 with 8 (eight) observations, which we are addressing,” the company added.
The company didn’t disclose the nature of these observations.
The US drug regulator conveys its concerns on manufacturing practices through Form 483. Companies that receive observations must respond in writing with a corrective and preventive action plan in 15 days.
The company’s Duvvada unit, known as FTO-VII, manufactures cytotoxic and hormonal injectables is under warning since November 2015, blocking any new approvals.
The inspection has begun on October 22.
Duvvada plant is crucial for the company as a portion of complex abbreviated new drug applications (ANDAs) were filed from this facility. Complex injectable drugs have limited competition and a better margin profile compared to oral solids like tablets.
In 2015, the regulator had issued a warning letter to the company, citing serious deficiencies in the current good manufacturing practices followed at the plant. The company from then onwards hired external consultants and is working towards resolving the issues raised by USFDA.
But the resolution seemed elusive as in a follow-up inspection in February-March 2017 the USFDA issued 13 observations for the Duvvada unit, many of which were repeat violations from its 2015 inspection.
The company, which is confident about a resolution, once again invited USFDA in June for re-audit early this year.
The announcement came after market hours.
Shares of Dr Reddy’s rose 2.48 percent to close at Rs 2597.70 on BSE, while the benchmark Sensex dropped 0.52 percent to end at 33,891.13 points.