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May, 08 2018

USFDA completes Inspection of Suven Life Sciences' Pashamylaram facility

The facility has undergone renewal inspection from February 5-18 by the United States Food and Drug Administration (USFDA).

Drug firm Suven Life Sciences has confirmed that 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 (USFDA), 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 5 abbreviated new drug applications (ANDA's) from this facility, Suven said.

The company's stock was trading 5.43 per cent up at Rs 191.10 on BSE in the afternoon.

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