Suven Life up 6% as Pashamylaram's unit completes USFDA inspection

The stock moved higher by 6% to Rs 192 on the BSE in noon deal after the company's Pashamylaram's unit successfully completed the USFDA inspection

Suven Life Sciences has moved higher by 6% to Rs 192 on the BSE in noon deal after the company’s Pashamylaram’s unit successfully completed the United States Food and Drug Administration (USFDA) inspection.

So far Suven Life Sciences has filed 19 DMF’s (Drug Master File) and 5 ANDA’s (Abbreviated New Drug Application) from this facility which is FDA complaint under Current Good Manufacturing Processes (cGMP) and continued after renewal inspection.

The company said it has undergone US FDA renewal inspection at their facility in Pashamylaram near Hyderabad for the manufacture and supply of active pharmaceutical ingredients (bulk drugs), intermediates and formulations under cGMP during Feb 5th through 15th 2018.

Based on this FDA inspection and the review thereafter, the facility is considered to be in an acceptable state of compliance with regards to CGMP and the agency has determined that the inspection classification of this facility is “no action indicated (“NAI”). Also FDA has concluded that the inspection is “closed” under 21CFR20.64 (d) (3) and the agency has issued an Establishment Inspection Report (EIR) for Suven facility at Pashamylaram, it added.

At 02:26 pm; the stock was trading 5% higher at Rs 190 on the BSE, as compared to 0.71% rise in the S&P BSE Sensex. A combined 1.08 million shares changed hands on the BSE and NSE.