Evotec OAI Undergoes Successful FDA Inspection

Hamburg, Germany | Oxfordshire, UK - Evotec OAI AG (Frankfurt Stock Exchange: EVT, TecDAX 30), a leading partner for integrated, high-value-added drug discovery and development solutions, today announced a recent successful combined general GMP audit and FDA pre-approval inspection of its cGMP manufacturing facilities to manufacture a sophisticated active pharmaceutical ingredient (API). No Form 483 was issued from this inspection. 
Dr Mario Polywka, President Chemical and Pharmaceutical Development Division at Evotec OAI, said: "Following our successful inspection for the manufacture of an approved API in 1999, it is again gratifying to receive validation of our high quality process development, manufacturing, analytical and quality assurance capabilities through this audit. This confirms the position of Evotec OAI's CPD Division as a world leader in the supply of customer's development needs through its EVOdevelop platform. Additionally, it gives me the opportunity to acknowledge and thank the tremendous colleagues at Evotec OAI who helped make this possible."
Evotec OAI, through its integrated platform, EVOdevelop, is ideally positioned to address its partners' needs for chemical and pharmaceutical development resources and expertise in order to allow them to move development candidates time and cost effectively through pre-clinical testing into clinical trials and ultimately to market.
EVOdevelop integrates leading skills and state-of-the-art laboratory and production facilities in process research and development, custom preparation, scale-up and manufacturing and formulation - all supported by the very best in analytical and regulatory expertise.
With over 10 years of experience Evotec OAI has a proven track record in drug development and, to date, has supported more than 200 partners, in particular biotechnology companies.
 About Evotec OAI AG
Evotec OAI has established itself as the partner of choice for drug discovery and development solutions for pharmaceutical and biotechnology companies worldwide, maintaining its leadership role through innovation and unmatched customer service.
The Company's business strategy is clearly focussed on drug discovery. It has established the most comprehensive technology platform and skills that integrate its world-class biology and chemistry capabilities. Evotec OAI leverages this discovery engine in providing assay development and screening through to compound optimisation and drug manufacturing services to a broad and well-established network of customers. In addition, the Company engages in selected discovery programmes itself to develop drug candidates for early out-licensing. Evotec OAI's instrument and technology business is now successfully handled by its affiliate, Evotec Technologies.
With over 600 people in Hamburg, Germany and Oxfordshire, UK, Evotec OAI is dedicated to returning value to its shareholders and employees through a sustainable business strategy that balances short-term and long-term revenue opportunities.
Contact: Anne Hennecke, Corporate Communications, Evotec OAI AG, Phone: +49-40-56081-286, anne.hennecke@evotecoai.com
Contact: Anne Hennecke, Corporate Communications, Evotec OAI AG, Phone: +49-40-56081-286, anne.hennecke@evotecoai.com