The US Food and Drug Administration (USFDA) has issued an Establishment Inspection Report to Suven Life Sciences' unit at Pashamylaram near here, thus concluding an inspection it had undertaken in February, the company said on Monday.
The unit, set up for the manufacture and supply of active pharmaceutical ingredients, intermediates and formulations, has successfully completed the renewal inspection, Suven informed the stock exchange.
Based on the inspection and the review thereafter, the facility is considered to be in an acceptable state of compliance with regards to Current Good Manufacturing Processes (CGMP). The USFDA has determined that the inspection classification of the facility is “no action indicated (NAI)’’. The regulator had inspected the unit from February 5-15, the company said.
So far, 19 Drug Master Files (DMF’s) and 5 Abbreviated New Drug Applications (ANDA’s) had been filed from the Pashamylaram facility.
