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USFDA warning letter to Torrent Pharma remains unresolved with latest OAI status

USFDA warning letter to Torrent Pharma remains unresolved with latest OAI status

USFDA warning letter to Torrent Pharma remains unresolved with latest OAI status
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By CNBCTV18.com Jan 24, 2023 7:04:14 PM IST (Published)

In September 2022, the USFDA issued Form 483 with 3 observations for the Indrad manufacturing unit of Torrent Pharma.

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 Torrent Pharmaceuticals Ltd. has received a notice from the United States Food and Drug Administration (USFDA) with Official Action Indicated (OAI) observations for the company’s manufacturing facility in Indrad, Gujarat.

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The company said that following the inspection and issuance of Form 483 by the USFDA it received a communication from the US drug regulator with the OAI inspection classification for the manufacturing facility at Indrad in the Mahesana district.


In September 2022, USFDA issued a Form 483 with 3 observations for the Indrad manufacturing unit of Torrent Pharma. The inspection was carried out at the Indrad facility from September 19 to September 28, 2022.

Form 483 is issued to a company when any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts are found during the inspection of a manufacturing facility.

Torrent Pharma said that it continues to cooperate with the USFDA and will undertake all necessary remedial steps to resolve these issues to the satisfaction of the regulator. Torrent Pharma remains committed to being cGMP-compliant quality standards across all its facilities.

Last month, Torrent Pharma entered into a strategic alliance with Boehringer Ingelheim India Pvt. Ltd. to co-market its anti-diabetic drug and its fixed-dose combinations in India.

In India, Cospiaq (Empagliflozin), Cospiaq MetTM (Empagliflozin+ Metformin), and Xilingio (Empagliflozin+ Linagliptin) will be co-marketed by the company, according to the agreement.

Shares of Torrent Pharma ended 0.73 percent lower at Rs 1,585.95 on Tuesday.

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