Aurobindo Pharma drops up to 3% as USFDA concludes inspection at Telangana unit with 7 observations

Shares of Aurobindo Pharma Ltd dropped nearly 3% on Friday after the United States Food and Drug Administration reported flagged procedural lapses at the company's subsidiary unit in Telangana.

The US drug regulator in its inspection closure report raised concerns regarding procedural and cleanliness issues at Aurobindo Pharma's subsidiary, Eugia Pharma SEZ unit, located in Telangana, according to reports.

Aurobindo Pharma subsidiary's Telangana plant received seven observations in its Form 483 after an inspection conducted by USFDA from February 19 to 29, 2024.

The USFDA noted that procedures to prevent contamination were not followed, and written records were not maintained, leading to unexplained discrepancies, according to reports.

The US drug regulator also found that equipment was not suitably located to facilitate operations.

The USFDA also highlighted that employees engaged in manufacturing and processing the drug product were not properly trained. Also, the manufacturing unit did not have procedures to validate the performance of the manufacturing process and drugs.

On February 29, the Eugia Pharma SEZ unit resumed production in its terminally sterilised product lines at Unit-III. Production at the facility had been temporarily halted to address some of the observations made by the USFDA during its inspection.

Earlier, from January 22-February 2, 2024, the American drug regulator inspected Eugia Pharma’s unit-III, a formulation manufacturing facility, located at Pashamylaram in Sangareddy District of Telangana.

In a statement, the pharmaceutical company said that it would respond to these observations within the stipulated time. After that, it temporarily halted manufacturing on certain lines to conduct a comprehensive investigation and corresponding partial distribution.

shares of Aurobindo Pharma closed 1% lower at ₹1,000 apiece on NSE.