Indoco Remedies Ltd., a Mumbai-based fully integrated, research-oriented pharma company, has received approval from US Food and Drug Administration for its sterile facility (plant-II) and solid dosage facility (plant –III) located at Verna in Goa.
The approval follows the inspection of both these facilities last year by the US Food and Drug Administration between August 22-30, 2013.
With this approval, Indoco now has six of its facilities, approved by the US FDA. The six US FDA approved facilities include, three for finished dosages, two for APIs and one for analytical.
“The approval will now facilitate the generic (ANDAs) approvals in the US market and subsequent product launches there. Without doubt, it will also boost the high-margin revenues of Indoco from the remunerative market of US and placing Indoco in the elite league with other International and Indian pharmaceutical companies,” said Suresh G Kare, chairman, Indoco Remedies Ltd.
Indoco Remedies, that derives 93 per cent of its revenues from formulations and the balance through APIs, has export revenues worth 35 per cent in its overall annual net revenue pie of Rs.730 crore for the year ended March 31, 2014.