Ipca Laboratories halts shipments to US on FDA concerns

Ipca Laboratories has temporarily suspended shipments to the United States from one of its drug ingredient manufacturing plants after the US Food and Drug Administration (FDA) expressed concerns regarding the unit.

The shipment halt from the company's Ratlam manufacturing facility located in Madhya Pradesh will also impact Ipca's US drug exports from its Silvassa and Indore plants, where the company makes drugs using ingredients from its Ratlam plant, Ipca said in a statement on Thursday.

Ipca said the FDA issued it a so-called "Form 483", a letter in which the agency typically outlines concerns discovered during inspections.

The company, which is one of the largest makers of drug ingredients in India, added it is "fully committed in resolving this issue at the earliest," and will resume shipments only after it has addressed all FDA concerns at Ratlam.

Ipca's shares were down 6.8 per cent to Rs 780.90 as of 11.18 am.

(Reuters)