The US FDA has completed its inspection of Dr Reddy’s API plant in Srikakulam, Andhra Pradesh and issued the firm with a Form 483 detailing two observations.
With no active production at the plant since 2013, the company said it would shutter its Mumbai, India-based facility in mid-September, according to a Bombay Stock Exchange filing.
Hospira has begun commercial production at a sterile injectable plant in India hit with several 483 forms after the US FDA deemed the site ‘acceptable.’
GSK halted production in Rajahmundry, India and Eisai postponed the opening of a facility in nearby Vizag on Saturday after days of unrest over plans to create a new state, Telangana, within Andhra Pradesh.
Dr Reddy's Laboratories has boosted its ability to serve Western
pharmaceutical markets with an increase in its manufacturing
capacity for drug formulations.
