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The stock of Alembic Pharmaceuticals rallied over 6 per cent last Thursday. This followed news of an all-clear by US FDA after the company’s facility at Panelav, Gujarat, was inspected. The company did not receive any Form 483 observations from the regulator.
This successful inspection is critical for the company’s growth plans, as in fiscal 2016, it derived around 46 per cent of its overall revenue from international formulations which reported strong growth of 146 per cent Y-o-Y. While domestic revenue share was at 38 per cent, active pharmaceutical ingredients (APIs) contributed the rest.
The company had set-up its office in the US last year and launched 11 products under its own label. As of March, 2016, the company had filed 76 abbreviated new drug applications and 81 drug master file applications with the US FDA.
On the India front, its specialty product segments in cardiology, anti-diabetic and gynaecology posted strong growth. Its domestic products are marketed by its 5,000-odd medical representatives.
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