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This is an archive article published on October 11, 2019

Indrad unit of Torrent Pharma gets observations from USFDA

In April, the US FDA had conducted an inspection of the Indrad facility which manufactures both API (Active Pharma Ingredient) and formulations with an annual capacity of 30 million vials.

In April, the US FDA had conducted an inspection of the Indrad facility which manufactures both API (Active Pharma Ingredient) and formulations with an annual capacity of 30 million vials.

The Indrad facility of Torrent Pharmaceuticals in Gujarat received a warning letter from the US Food and Drug Administration (US FDA), the company told the BSE in a filing on Thursday.

“This is to inform that the company has today received a warning letter dated October 8 from USFDA for its Indrad facility in Gujarat. This action follows the earlier intimation received from USFDA in August 2019, wherein the agency had classified its inspection as ‘Official Action Indicated’ (OAI),” the filing read.

It added, “We will be engaging with the agency and are fully committed in resolving this issue at the earliest. The company is also committed to maintaining the highest standards of compliances and quality manufacturing across all its facilities.” The Indrad facility is one of the seven manufacturing facilities of the company in India.

In April, the US FDA had conducted an inspection of the Indrad facility which manufactures both API (Active Pharma Ingredient) and formulations with an annual capacity of 30 million vials.

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