FDA indicates official action on Jubilant Pharmova Roorkee facility

Jubilant Pharmova said that the US Food and Drug Administration (FDA) has determined the inspection classification of its solid dosage manufacturing facility in Roorkee, Uttarakhand.

The communication by the FDA was given to the company’s fully-owned subsidiary Jubilant Pharma’s subsidiary Jubilant Generics Limited (JGL). The inspection classification of the solid dosage manufacturing facility has been determined by the FDA as “official action indicated”, which means the regulator has found objectionable conditions at the pharma manufacturing plant and its regulatory administrative sanctions are indicated.

Jubilant Pharmova said that it presently supplies one product to the American market which contributes low-single digit revenue to its revenues. However, the Indian pharma company added that it has been cooperating continuously with the FDA and will take up all the required measures for resolving regulatory status at the solid dosage manufacturing facility in Roorkee.