Aurobindo Pharma Pegs Impact Of Europe Drug Regulator’s Decision At $5 Million
Aurbobindo Pharma has five products “with different strengths” that are affected by the order.
Aurobindo Pharma Ltd. said the impact of European Medical Agency’s (EMA) order recommending suspension of around three hundred drugs tested by an Indian contact research organisation – Micro Therapeutic Research Labs organisation – will be up to $5 million per annum.
Aurbobindo Pharma has five products “with different strengths” in select countries of the European Union which are affected by the decision, the drugmaker said in a stock exchange filing. Some of these five medicines are yet to receive approval from necessary authorities, the filing added.
The European drug regulator on Friday had recommended suspending sales of some approved generic drugs which had been tested at two laboratories managed by Micro Therapeutic Research Labs in India. The regulator said the “bioequivalence” studies, which form the basis for approval of generic medicines, conducted by the Indian research lab were unreliable. Bioequivalence studies are conducted on medicines which claim to share the same effect.
The inspections identified several concerns at the company’s (Micro Therapeutic Research Lab) sites regarding misrepresentation of study data and deficiencies in documentation and data handling.European Medical Agency
Aurobindo Pharma fell as much as 3.4 percent on Monday as investors reacted to the news.