Shares of Shilpa Medicare Ltd rose 5% to touch a day’s high of Rs 937.10 on 16th July, after the company announced it had received an Establishment Inspection Report (EIR) from the US FDA for its Bengaluru unit.

In a filing on 16th July, Shilpa Medicare stated that its Unit VI in Dabaspet, Bengaluru, has received an Establishment Inspection Report (EIR) from the US FDA. This report came with a Voluntary Action Indicated (VAI) classification. A VAI indicates that the plant had some observations during inspection, but the company’s response was deemed satisfactory. It is considered the second-best classification by the U.S. Food and Drug Administration.

The US FDA conducted a Good Manufacturing Practices (GMP) inspection at the facility between 24th and 30th October, 2024.

This unit will handle the manufacturing, packaging, testing, storage, and distribution of two advanced dosage forms. These forms are oral dissolving films and transdermal systems.

The company also noted that this unit has already been approved by several global regulators, including the EMA (Europe), MHRA (UK), SFDA (Saudi Arabia), and TGA (Australia). It currently supplies oral film products to the U.S. and other markets. Meanwhile, its transdermal products have been filed in the European market.

Back in March, the company had also completed a US FDA inspection at Unit-1 of its subsidiary, Shilpa Pharma Lifesciences, in Raichur.

At 12:15 PM, the shares of Shilpa Medicare were trading 5% higher at Rs 937.10 on NSE.

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