Viatris faces FDA import restrictions at Indian facility

Viatris (Nasdaq: VTRS) has disclosed that its oral finished-dose manufacturing facility in Indore, India, is subject to action from the US regulator, after an inspection earlier this year.

The US Food and Drug Administration (FDA) has issued both a warning letter and an import alert, barring 11 products from entering the US market, while making exceptions for four products due to drug shortage concerns.

Viatris, a generics specialist, said there was the potential for additional carve-outs, depending on further discussions. The affected facility produces tablets and capsules across therapeutic categories such as antibacterials, diabetes treatments, and cardiovascular therapies.