The US Food and Drug Administration has sent a warning letter to Emcure Pharmaceuticals for ‘significant violations’ of current good manufacturing practice at its Pune-based plant, adding it to the list of Indian drugmakers that have received such a letter.
In the letter dated March 3, the US FDA said the company's plant at Hinjewadi was inspected between January 27 and February 4, 2015. A warning letter increases the risk of the US drug regulator imposing a ban on imports from the factory.
The significant violations noted by the regulator includes non-adherence to appropriate written procedures, following poor aseptic processing techniques that may compromise the sterility of injectable products, serious gaps in the management of the environmental monitoring programme.
The US FDA also noted that Emcure had committed to the regulator in 2014 that it would improve processes at its plant. Yet, in the 2015 inspection, the FDA found "continuing practices of data falsification and manipulation at your facility, indicating that previous corrections were ineffective".
The regulator has given Emcure 15 working days within the receipt of the letter to notify in writing the specific steps it has taken to correct and prevent the recurrence of violations.
Until all corrections are made, the FDA said it may withhold approval of any new applications or supplements listing of Emcure as a drug product manufacturer.
"In addition, your failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at Emcure Pharmaceuticals... into the US," it added.
Emcure, which is backed by private equity firm Bain Capital, has eight plants in India, and exports to the US, Europe, Brazil and Japan.
In December 2013, Bain Capital had bought 13.09 per cent stake in Emcure from PE major Blackstone for an undisclosed amount.
Following the deal, Emcure had pulled out its proposed initial public offer (IPO) which was to raise around Rs 300 crore besides giving part exit to Blackstone in its maiden investment in India.
Indian pharmaceutical companies, which supply about 40 per cent of the generic drugs sold in the US, have come under greater scrutiny from the FDA over quality issues for the past couple of years.
Early in December, the FDA shot a warning letter to India's top drugmaker Sun Pharmaceutical Industries Ltd about its Halol facility in Gujarat.
India's second-largest drugmaker Dr Reddy's Laboratories Ltd and another drugmaker Cadila Healthcare Ltd also received warning letters from FDA citing quality control issues in recent times.