“The company has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA), for the Active Pharmaceutical Ingredients (API) manufacturing plant at Srikakulam, Andhra Pradesh (CTO VI), indicating closure of the audit and the inspection classification of this facility is determined as "Voluntary Action Indicated" (VAI),” Dr Reddy’s Laboratories said in a regulatory filing.
The site was issued warning letter in November, 2015 after the inspection in 2014, and was under "Official Action Indicated" classification till now. With this, all facilities under warning letter are now determined as VAI, it said.
Analysts at Anand Rathi Share and Stock Brokers believe the US business which has been facing revenue pressure, is likely to rebound with new product launches and gradual normalization of price erosion in its key products. Also, Dr Reddy’s should continue to witnesses strong growth in India, emerging markets, Europe and PSAI business driven by volume growth, new launches and improving realizations.
While the deal with Wockhardt strengthens India business, other strategic initiatives of the company focused on building healthy product pipeline, improving efficiency and cost controls, divesting on-core assets and engaging with USFDA to resolve outstanding concerns, create further optimism, the brokerage firm said in value pick.
At 09:42 am, Dr Reddy’s was trading 4 per cent higher at Rs 3,970 on the BSE, as compared to 1.5 per cent rise in the S&P BSE Sensex. A combined around 600,000 equity shares have changed hands on the counter on the NSE and BSE.