Shares of Torrent Pharma are higher by over 2.5% in trade on November 22 after the company informed of a Establishment Inspection Report (EIR) by the USFDA for its facility at Pithampur, Madhya Pradesh, stating that the company has initiated voluntary action.
"...USFDA has issued Establishment Inspection Report (“EIR”) with Voluntary Action Indicated (“VAI”) classification for the said manufacturing facility and the inspection has now been successfully closed by the USFDA," Torrent Pharma said, informing about the closure of the inspection.
The USFDA's Establishment Inspection Report (EIR) is a report summarizing findings of an inspection at a facility, mentioning compliance issues if any, and discussions during the visit. The USFDA assigned a Voluntary Action Indicated (VAI) classification, implying the company can voluntarily address the deficiencies without any administrative or regulatory action.
The USFDA had inspected Torrent's manufacturing facility at Pithampur in the September quarter, and issued a Form 483 with one observation.
Torrent Pharma registered constant currency revenue of $32 million, up by 7% on year, Sequentially, Torrent said its US businesses have delivered stable revenue. Torrent has said that it does not expect the US business to ramp up anywhere very fast in the next two years, since most of its filed ANDAs are old, and it expects 'low single digit approval' of newer ANDAs.
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