Commenting on a warning letter issued by the US Food and Drug Administration (FDA) on, relating to its Agila Specialty Formulation Facility (SFF), Sterile Product Division (SPD), and Onco Therapies Limited (OTL) sites in India, Heather Bresch, Chief Executive Officer, Mylan, said, “Since Mylan acquired the Agila injectables businesses in December 2013 to create a leading global injectables platform, we have been taking extensive action to integrate the Agila business into Mylan’s one quality standard, and to ensure our leading position as a high quality, reliable source of injectables for the long term.”
Emphasising that this agency action has no material impact on Mylan’s business or its previously announced full year earnings guidance, the company quoted Bresch, “As part of this ongoing process, we have a deep and unwavering commitment to quality everywhere we operate. We have been and will continue to work diligently to address all of the FDA’s observations and have made important progress.”
This action follows inspections of the three sites by FDA in 2014 and February 2015, which the company has disclosed previously.
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