Mylan Inc., one of the world’s leading generic and specialty pharmaceutical companies, and Indian subsidiary Mylan Pharmaceuticals Private Ltd, has commenced commercial operations in India, starting with the launch of a comprehensive portfolio of 18 antiretroviral (ARV) products for the treatment of HIV/AIDS. India is home to the world’s third largest population of people with HIV/AIDS, with approximately 2.4 million people living with the disease, of which fewer than 20 per cent have access to treatment.
Heather Bresch, CEO, said, “Mylan’s mission is to provide the world’s 7 billion people with access to high quality medicine. Through the initial launch in India of a broad and innovative ARV portfolio, we are taking another significant stride towards meeting that goal. We believe that Mylan can set a new standard in the treatment of HIV/AIDS in India by providing healthcare providers and those living with the disease access to high quality, affordable medicines and by supporting physicians in their efforts to educate and treat their patients through our innovation, reliability and service excellence. We see significant growth potential in India, the world’s second largest pharmaceutical market by volume, and look forward to continuing to expand our operations in India in additional therapeutic categories.”
Mylan has been a leading global player in the ARV arena for nearly a decade. In 2002, Mylan Laboratories Limited (formerly Matrix Laboratories), began providing reliable supplies of ARV active pharmaceutical ingredients (API) to generic drug makers. In 2007, the company began offering finished dosage forms and launched a line of paediatric ARVs. Today, Mylan is widely respected for the quality, dependability and affordability of its ARV franchise, and the company’s ARV products are used by nearly one-third of all people receiving treatment today for HIV/AIDS in the developing world.
Mylan President Rajiv Malik said, “Mylan has helped to significantly drive down the cost of ARV therapies, while ensuring that quality remains paramount. Globally, we now offer a portfolio of 43 innovative, high quality ARV drugs, and the launch of 18 of these products in India represents an exciting first step in this important market. Since Mylan’s founding more than 50 years ago, we have been committed to filling unmet needs with our quality products, and we intend to maintain these same high standards with the products we sell in India.”
Mylan’s Nashik, India facility, which produces the company’s finished-dosage-form ARVs for markets around the world including India, has been subject to Good Manufacturing Practices (GMP) inspections by several leading regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO).
Mylan also has introduced a number of ARV innovations, for instance producing single blister “combo” packs, which provide a reduced pill burden and once-a-day dosage. Mylan also developed three FDA/WHO-approved heat-stable ARV products, which can be distributed and used in warm climates where refrigeration infrastructure is not widely available. In addition, Mylan has been a global leader in producing ARV formulations for paediatric use.
A Mylan sales force—one of the largest field forces exclusively specializing in HIV/AIDS in India—will leverage the company’s global expertise to market Mylan’s high-quality, innovative ARV portfolio to HIV/AIDS specialists across the country. The Mylan portfolio will initially include a comprehensive range of 18 products, including heat stable, combination, and paediatric formulations.
In addition to providing a broad range of ARV products, Mylan will launch several initiatives aimed at educating and supporting medical professionals in their efforts to more effectively treat their patients and helping patients better manage their disease.
Mylan expects to enhance its commercial portfolio by adding additional therapeutic categories, and expects to continue to build out its sales force across India to support this ongoing business expansion.
Mylan offer a growing portfolio of more than 1,100 generic pharmaceuticals and several brand medications. In addition, it offer a wide range of antiretroviral therapies, upon which approximately one-third of HIV/AIDS patients in developing countries depend. The company also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 150 countries and territories.