Mylan N.V. has issued a statement on the warning letter issued by the US Food and Drug Administration (FDA) on August 6, 2015, relating to its Agila Specialty Formulation Facility (SFF), Sterile Product Division (SPD), and Onco Therapies Limited (OTL) sites in India.
Following the news of the warning letter which was published, the company has indicated that this action follows inspections of the three sites by FDA as much as a year ago, in 2014 and February 2015, which Mylan has disclosed previously.
This Agency action has no material impact on Mylan's business or its previously announced full year earnings guidance, said the company’s communique.
"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. 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, said Heather Bresch, CEO, Mylan.
Mylan is a global pharmaceutical company with a workforce of 30,000 offering a growing portfolio of around 1,400 generic drugs and several brand medications. In addition, it has a wide range of antiretroviral therapies, upon which nearly 50 per cent of HIV/AIDS patients in developing countries depend.