Solara Active Pharma Sciences is going to carry out internal probe on Nizatidine API amid the voluntary recall of Nizatidine API by Mylan. The company is in the process of collecting corresponding lots of API from Mylan to carry out internal investigation.
Mylan N.V.'s US 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.
Solara Active Pharma Sciences’ last supplies of Nizatidine API to Mylan were made in September 2017.
Solara Active Pharma Sciences is a young, dynamic, entrepreneurial and customer oriented API manufacturer.
