Torrent Pharma Drops The Most In Five Months On U.S. FDA Observations

Shares of Torrent Pharmaceuticals Ltd. dropped after the drugmaker received observations from the U.S. health regulator over manufacturing standards at its Dahej, Gujarat plant.

The Ahmedabad-based company received five observations, one of them a repeat of 2017, after the U.S. Food and Drug Administration conducted an inspection between March 11 and March 19, according to the Form 483 on the American regulator's website.

The U.S. FDA's second observation implies that several quality control documents were found to be shredded. These reports included excel sheets of stability study reports, records of sampling details, sampling tracking sheets and sampling insurance record.

“The company may get a warning letter in case the deficiencies are not responded in detail,” said Amit Rajan managing director of Prosfora Technologies. “While observation 1 is a repeat, which means the company has not yet made any progress in making the changes the FDA had suggested in 2017, observation 2 seems serious.” “Some of the observations clearly mention huge data integrity issues,” he said.

Torrent Pharmaceuticals, however, said the U.S. FDA observations don't mention any remark on data integrity issue. “These are procedural in nature and the company is confident of responding the same satisfactorily,” a company spokesperson said in an emailed response to BloombergQuint's query.

The Dahej plant is new but is strategically important for the company as several new filings come from this unit. 75 percent of Torrent Pharmaceuticals' U.S. revenue comes from its Indrad, Gujarat facility, while the rest comes from Dahej.

Torrent Pharmaceutical's stock fell as much as 3.6 percent on NSE—the most in five months—after the drugmaker received the observations.

Observations

• There's a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. (This is a repeat observation of 2017 inspection).
• Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
• All records of production, control and distribution associated with a batch of drug products were not maintained at least after expiration.
• Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the drug product had already been distributed.
• Written records of investigation into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow up.