Unichem gets two US FDA observations for its Ghaziabad plant

Viswanath PillaMoneycontrol NewsUnichem Laboratories on Monday said it received two observations from US FDA for its formulation facility at Ghaziabad, Uttar Pradesh.The facility was inspected by the US drug regulator from February 24 and March 3. "The two observations cited are, in the opinion of the company, correctable ones in respect of which the company will file the necessary response within the stipulated period of 15 working days," Unichem said in a statement to stock exchanges."The observations do not impact business continuity and the company's supplies to the US market," Unichem statement added.Shares of Unichem rose 3.35 percent and were trading at Rs.265.85 on BSE at 1.13 pm, the benchmark Sensex gained 0.49 percent to 28,979.44 points.Ghaziabad facility along with Goa plant caters to US formulation market.Unichem has 38 ANDAs filed so far and 21 of which are already approved and many more filings in the pipeline, the company said in its presentation on Monday.The company has sales of Rs 1335 crore in FY16. International formulation business which includes US contributed around Rs 270 crore or 21 percent of the business.