Scientific Affairs at Mylan includes portfolio management, R&D, regulatory affairs and clinical research. The scope and capabilities of this function includes product development, analytical development, packaging development, clinical development, bioanalytical development, regulatory and intellectual property.
The company’s R&D facilities in India focus on global development programs for Australia, Canada, Europe, Japan, New Zealand, South Africa, the U.S. and other emerging markets with core expertise in active pharmaceutical ingredients (API), antiretrovirals, injectables, nasal sprays, ophthalmics, oral solid doses (OSD) and transdermals.
Mylan makes significant investments in R&D each year and has two global R&D centers of excellence that serve markets around the world, one of which is based in Hyderabad, India, where a team of highly-qualified scientists and regulatory affairs professionals research APIs, OSDs and biologics. Another team of scientists is located at an R&D center in Bangalore focus solely on researching injectables. We also have an R&D center located in Ahmedabad through our Famy Care deal focused on women’s care products. In addition, Mylan’s packaging-development team in India identifies, characterizes and designs packaging components to develop suitable container and closure systems for all products in Mylan’s R&D portfolio.
Since 2005, the R&D center in Hyderabad has increased from 32,000 square feet to nearly 250,000 square feet in 2013, another example of Mylan’s commitment and investment to the platform in India. The facility is accredited by several regulatory authorities, including the Drug Controller General of India, U.S. Food and Drug Administration, World Health Organization and several European regulatory authorities.