Indian pharma major Aurobindo Pharma Ltd. said that the US Food and Drug Administration (US FDA) has classified a plant operated by its subsidiary in Tirupati as "Voluntary Action Indicated" ("VAI").
The inspection was conducted at Unit IV of APL Healthcare Limited, a wholly-owned subsidiary of the company, situated at Menakuru Village, under the Naidupeta Mandal, in Tirupati District of Andhra Pradesh.
This is a formulation manufacturing facility. The inspection happened between September 13 and September 19, 2023.
The FDA designates a manufacturing unit as VAI (Voluntary Action Indicated) when it identifies deficiencies during its inspection that, while noteworthy, do not warrant official regulatory action.
Also read: Cash Market | Aurobindo Pharma breaking out of a flag trend pattern
With VAI status in place, companies are permitted to seek approvals for new drugs from the facility and continue the commercialization of previously approved medications. This designation represents the second-highest classification attainable by a pharmaceutical manufacturing facility under the scrutiny of the US FDA.
The company had earlier reported an 85 percent year-on-year rise in consolidated net profit to Rs 757 crore for the July-September quarter of the current financial year.
Aurobindo Pharma shares hit a record high of Rs 1,081.95 a piece around 1 pm on December 20. The stock has gained 147 percent this year, so far.
Also read: Aurobindo Pharma Q2 results: Net profit jumps 85% to Rs 757 crore
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