Lupin shares slip 5% after FDA alert on MP plant

The company has received one drug approval and two site-transfer approvals from same plant since FDA audit

Shares of Mumbai-based Lupin fell five per cent on the BSE on Monday after the US Food and Drug Administration (FDA) has raised concerns over production processes at the company’s Pithampur plant in Madhya Pradesh.

According to reports, US FDA issued Lupin a so-called Form 483, listing six observations on the manufacturing processes at the plant after the inspection in January this year. According to the Form 483, FDA will seek corrective action from the company while it will not issue an import ban.

The shares closed at Rs 1645, down 2.71 per cent or Rs 45.85 on the BSE.

Lupin had received one drug approval and two site-transfer approvals from the same plant since the FDA audit, reports said.  Pithampur plant produces oral contraceptives and ophthalmic drugs for sale in the United States.

In last one year, many of the Indian pharmaceutical majors have come under US FDA scanner and issued import alert - banning them from selling drugs in the US. After the strong warning issued against Wockhardt, others like Sun Pharma, IPCA Labs, Cadila have faced the wrath of FDA.