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This is a formulation manufacturing facility.
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.
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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.
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Also read: Aurobindo Pharma Q2 results: Net profit jumps 85% to Rs 757 crore