Last Updated on December 31, 2023 by The Health Master
Aurobindo Pharma announced that the United States Food and Drug Administration (USFDA) has issued Form 483 with 10 observations after the inspection of its Unit IX, Gundlamachnoor facility.
The drugmaker said that Unit IX, an intermediate facility situated at Gundlamachnoor Village, Sangareddy District, Telangana, had been classified as OAI (official action indicated) on May 17, 2019, and the company had responded to the agency and carried out the required corrective actions.
The US drug regulator reinspected the facility from November 10 to 18, 2022.
At the end of the inspection, the pharmaceutical company was issued a Form 483, with 10 observations.
The observation is procedural in nature and not related to data integrity, the pharma company stated.
The pharma major added that it will respond to the USFDA, within the stipulated timeline and will work closely with the agency to address the observations at the earliest.
Aurobindo Pharma develops, manufactures, and distributes generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients.
The pharmaceutical company reported a 41.3% fall in consolidated net profit to Rs 409.45 crore on a 3.7% decline in net sales to Rs 5,673.65 in Q2 FY23 over Q2 FY22.
Shares of Aurobindo Pharma were down 1.13% to Rs 468.75 on Friday, November 18, 2022.
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