Hyderabad: City-based pharma playerAurobindo Pharma Limited on Monday informed the bourses that the recent decision of the European Medicines Agency (EMA) suspending drugs due to failure of bioequivalence studies is not going to have a material impact on the company. "Aurobindo Pharma has five products with different strengths in select EU countries which are affected due to the EMA decision on the CRO (contract research organisation). Some of these products are not currently in the market and, in fact, are awaiting approval in some countries. The combined sales of these products is less than $5 million per annum for the company," the company told the bourses.
The European drug watchdog had last week recommended suspension of a number of medicines for which bioequivalence studies (usually the basis for approval of generic medicines) were conducted by Micro Therapeutic Research Labs at two sites in Tamil Nadu in India . Micro Therapeutic Research Labs is a CRO that conducts the analytical and clinical parts of bio-equivalence studies, some of which are used to support marketing authorisation applications of medicines in the EU, EMA had said.
"The review, by EMA's Committee for Medicinal Products for Human Use (CHMP), concluded that data from studies conducted at the sites between June 2012 and June 2016 are unreliable and cannot be accepted as a basis for marketing authorisation in the EU. However, there is no evidence of harm or lack of effectiveness of medicines authorised and being evaluated in the EU on the basis of studies at the sites," EMA had said in its order. The Aurobindo pharma scrip ended the day in the red on the BSE on Monday, falling to a low of 665.15 a share before recovering marginally to close at 670.30, 2.56% lower than the previous close of 687.90 a share.
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