US FDA issues adverse observations on Glenmark plant

The firm makes dermatology products including ointment and contributes around 10% of its US sales

The US Food and Drug Administration (US FDA) has found deficiencies in manufacturing practices at Glenmark’s plant in Baddi and has issued seven adverse observations (known as Form 483) after an audit earlier this month.

The firm makes dermatology products including ointment and contributes around 10 per cent of its US sales. In the first half of FY18 the company earned Rs 1,772 crore in revenue from the US market, which accounted for 38 per cent of its total revenue.

The firm has around 70 products pending for approval in the US and five of them have been filed from the Baddi