09 August 2012 | News | By BioSpectrum Bureau
Mylan launches operations in India with 18 ARV products
Bangalore: Mylan Pharmaceuticals, a subsidiary of Mylan, 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.
Commenting on this important development, Mylan CEO Heather Bresch said, "Through the initial launch in India of a broad and innovative ARV portfolio, we are taking another significant stride towards meeting that goal. 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 is the third largest generic and specialty pharmaceutical company in the world. Mylan's Nashik facility in India, which produces the company's finished-dosage-form ARVs for markets around the world, has been subject to Good Manufacturing Practices (GMP) inspections by several leading regulatory authorities, including the US Food and Drug Administration (FDA) and the World Health Organization.
Mylan President Rajiv Malik added, "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."
According to National AIDS Control Organization (NACO), 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 percent have access to treatment.
The Mylan portfolio will initially include a comprehensive range of 18 products, including heat stable, combination, and pediatric 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 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 pediatric use.