Solara Active Pharma Sciences Limited has announced that from Mylan NVs press release1 dated January 08, 2020, the company understands that Mylan N.V.'s U.S. based Mylan Pharmaceuticals (Mylan) has initiated a voluntary recall of three lots of Nizatidine Capsules, USP (150mg and 300mg strengths) due to detected trace amounts of impurity N-nitrosodimethylamine (NDMA) contained in the Nizatidine API. Mylan also indicated that the recall is voluntary, and the Company has not received any reports of adverse events related to these batches to date.
The company is in the process of collecting corresponding lots of API from Mylan to carry out its internal investigation.
The last supplies of Nizatidine API to Mylan were made in September 2017 and overall sales of this API to the US market are less than 0.1 % of total company revenues.
Shares of Solara Active Pharma Sciences Ltd was last trading in BSE at Rs.420.55 as compared to the previous close of Rs. 424.95. The total number of shares traded during the day was 491 in over 76 trades.
The stock hit an intraday high of Rs. 424.2 and intraday low of 420.5. The net turnover during the day was Rs. 206919.