Indoco Remedies, a maker and marketer of formulations and active pharmaceutical ingredients (APIs), received approval from the United States’ drug regulator for two of its facilities in Goa.
The US Food and Drug Administration (USFDA) has approved the sterile facility (plant – II) and solid dosage facility (plant – III) located at Verna in the coastal state, a company release said.
With this, Indoco now has six of its facilities approved by the USFDA which 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. It will also boost the high-margin revenues of Indoco from the remunerative market of US and place Indoco in the elite league with other international and Indian pharmaceutical companies,” said Suresh G Kare, chairman, Indoco Remedies Ltd.
The USFDA nod also assumes significance in the backdrop of several pharmaceutical companies being indicted for compliance-related issues.
Indoco Remedies derives 93 per cent of its revenues from formulations and the balance through APIs. Export revenues accounted for 35 per cent in its revenue of Rs 730 crore for FY14.
(Edited by Joby Puthuparampil Johnson)