NEW DELHI :
The US Food and Drug Administration (FDA) issued a warning letter to Torrent Pharmaceuticals Ltd’s Indrad plant in Gujarat on Tuesday following an inspection of the facility in April, the company said in an exchange filing today.
This action follows the earlier intimation received· from US FDA in August 2019, wherein the agency had classified its inspection as "Official Action Indicated" (OAI).
“We will be engaging with the agency and are fully committed in resolving this issue at the earliest. The Company is also committed to maintaining the highest standards of compliances and quality manufacturing across all its facilities," the company said in the filing.
The US regulator classifies its observations as OAI when it believes that violations of current good manufacturing practices are severe and require urgent remedial measures. If the company fails to assure the regulator of undertaking remedial measures, the US FDA issues a warning letter to the plant. New product approvals are usually not given to a plant under warning letter.
After the regulator inspected the Indrad facility in April, it had issued a Form 483 with four observations, three for the finished drug product unit and one for active pharmaceutical ingredients (API) unit.
One of the observations for the finished drug unit was that the company failed to thoroughly review any unexplained discrepancy and failure of a batch, according to the Form 483, a copy of which was reviewed by Mint.
US FDA also cited that the company did not carry out investigations when APIs were found to be out of specification.
Torrent Pharma also did not calibrate its electronic and automatic equipment to a written programme designed to assure proper performance, US FDA said in the Form 483.
The regulator had also said that the company did not have written procedures for production of medicines at the plant so as to assure quality of the product.
“The fact that they will get a warning letter was already factored in when their observations were classified as OAI. With their Dahej plant also under OAI and under risk for a warning letter, it is unlikely they will be getting any product approvals this year," Amey Chalke, analyst for HDFC Securities said.
The US FDA had inspected the company’s other facility in Dahej in March, after which it had issued certain observations which were later categorized as OAI.
Both the plants manufacture active pharmaceutical ingredients as well as medicine formulations.
Out of the ₹7,673 crore that Torrent Pharmaceuticals generated in revenue in 2018-19 (Apr-Mar), ₹1,589 crore or 21% came from sale of medicines in the US, according to the company's annual report. The country is Torrent Pharmaceuticals’ second largest market after India.