Scientific Affairs

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 three 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.

Innovating
to Satisfy
Unmet Needs

Our R&D facilities have capabilities and infrastructure to provide end-to-end pharmaceutical services from formulation development to technology transfer.


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Product development capabilities

  • Beads for using Wurster processors
  • Bi-layered, orally disintegrating and sublingual tablets
  • Immediate- and modified-release tablets and capsules
  • Liquid filled hard gelatin capsules
  • Powder for oral suspension
  • Soft gelatin capsules

Technological capabilities

  • Dry powder layering
  • Extrusion spheronization
  • Hot melt extrusion
  • Multiple-unit pellet system
  • Nanonization technology - fenofibrate
  • Osmotic-controlled release oral delivery system
  • Tablet in tablet
  • Analytical and solid-state
  • Chemical synthesis
  • Chemistry and characterization
  • Complex iron compounds
  • High potent compounds
  • Peptides
  • Polymorphic forms and on bulk properties
  • Prostaglandins.

Collectively, Mylan’s scientists in India have filed more than 400 API patent applications in India, 60 in the U.S., 44 in Europe and 33 in other geographies.

Hyderabad also is home to our integral regulatory team that supports and works closely with the R&D teams and other cross functional teams. The regulatory team is responsible for new product submissions and lifecycle management in Australia, Europe, Japan, New Zealand, South Africa, the U.S., and emerging markets like Africa, Latin America, the Middle East, North Africa and South East Asia. The team also manages the maintenance of global submissions originating from certain global Mylan manufacturing sites and manages the change control management and regulatory compliance as well as provides support to third-party manufacturing sites.

Hyderabad also is home to a clinical research facility that develops and validates bioanalytical methods required to estimate drug/metabolite interactions in biological matrices for bioequivalence studies.