Aurobindo Pharma shares jumped more than 3.5% on Friday, February 16, after the pharma company said the United States Food and Drug Administration (USFDA) completed the inspection at the manufacturing unit of its synthetic peptides active pharmaceutical pngredient (API) business arm, Auro Peptides Ltd in Telangana.
The USFDA's inspection had zero observations, Aurobindo Pharma said in a stock exchange filing.
Aurobindo Pharma said the US regulator conducted an audit at the Auro Peptides’ manufacturing unit from February 12 to February 16, 2024.
The manufacturing unit of the company is located at the Indrakaran Village of Kandi Mandal in the Sangareddy District of Telangana.
The pharmaceutical company has come under regulatory scrutiny recently as its formulation manufacturing facility, Eugia Unit III, is likely to be facing compliance issues.
The US health regulator issued nine observations in an inspection conducted at the Eugia Unit III plant from January 22 to February 2, 2024.
As per industry experts, these observations pointed out by the USFDA indicate problems with paperwork and procedures. The key concerns raised in this 26-page Form 483 range from issues such as the lack of established procedures to prevent microbiological contamination of drugs purporting to be sterile, to incomplete lab records, and inadequate validation of aseptic processes.
Shares of Aurobindo Pharma were trading 1.39% higher at ₹1,029.25 apiece on BSE at 2:18 pm.
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