The facility near Hyderabad underwent inspection from February 5-18, 2018
Suven Life Sciences said its Pashamylaram facility near Hyderabad has undergone successful inspection by the US health regulator. The facility has undergone renewal inspection from February 5-18 by the United States Food and Drug Administration (US FDA), Suven Life Sciences said in a filing to BSE.
The plant is considered to be in an acceptable state of compliance with regards to current good manufacturing practices (CGMP) and the agency has issued an Establishment Inspection Report (EIR) for the facility, it added. So far the company has filed 19 Drug Master Files (DMF’s) and five abbreviated new drug applications (ANDA’s) from this facility, Suven said.