Formulations

Mylan Labs manufactures and supplies generic and branded generic formulations to various markets including North America, Europe and Asia Pacific. Our manufacturing capabilities cover various therapeutic categories such as ARVs, cardiovasculars, antibacterials, antidiabetics and CNS.  Mylan Labs has two state-of-the-art formulations manufacturing facilities, one near Nashik and the other near Aurangabad.

ARV Formulations: (Marketed by Matrix, a Division of Mylan Labs)

Since 2000, Mylan Labs has been at the forefront of addressing the HIV/AIDS pandemic by providing high-quality and cost-effective ARV active pharmaceutical ingredients (APIs). Today, Mylan is a leader in the ARV segment with more than one-third of the population receiving treatment for HIV/AIDS in developing countries using our products.

In 2007, Mylan Labs (formerly Matrix Labs) began offering finished dosage forms (FDFs) – first-linesecond-line and pediatric ARVs. Starting with six ARV drug products in 22 countries, Mylan Labs now provides 38 ARV drug products in 105 countries. Mylan products have been tentatively approved by the U.S. Food and Drug Administration through the President’s Emergency Plan for AIDS Relief (PEPFAR) and have been prequalified by the World Health Organization. In addition, our products have been approved by many countries in Africa, Asia and Latin America.

To learn more, visit:
U.S. FDA PEPFAR Program
WHO Prequalification Programme

Innovation, affordability and expanded access have been key to the success of our ARV franchise. Through our sustained research efforts the cost of first-line and second-line therapies are continuously reduced to make our products more affordable and available to people who need them in the developing world. In 2009, the company made available a first-line regimen costing $120, down from $1200 per person, per year and a second-line regimen costing less than $500, down from $15,000 per person per year.

Tenofovir, an ARV drug, is an example of a product development story that has been a great success for Mylan. The success of Mylan’s presence in the Tenofovir market is due to the development of a number of unique, first-to-file Tenofovir-based products and a continuous focus on reducing the cost of therapy through R&D efforts. We have been able to reduce the cost by 20%, year-on-year, for the last three consecutive years, thus making this widely effective product accessible to many patients across the developing world. 

Mylan Labs has developed many novel first-to-file products thereby touching more than 1 million patients receiving treatment for HIV/AIDS.

Mylan advocates for the use of treatment as prevention to control the spread of HIV. The company is committed to work with all stakeholders to build awareness of treatment as prevention policies. Mylan strongly believes that every HIV patient deserves to receive treatment that is safe and effective, and it is our goal to provide access to high quality, affordable ARV products.

We are the first generic company to develop and obtain WHO/USFDA approvals for the following products:

  • Tenofovir 300 mg Tablet
  • Tenofovir 300 mg & Emtricitabine 200 mg Tablet
  • Tenofovir 300 mg & Lamivudine 300 mg Tablet
  • Tenofovir 300 mg & Emtricitabine 200 mg & Efaviranz 600 mg Tablet
  • Tenofovir 300 mg & Lamivudine 300 mg & Efaviranz 600 mg Tablet
  • Heat stable Lopinavir 200 mg & Ritonavir 100 mg Tablets
  • Heat stable Ritonovir 100 mg Tablet
  • Heat stable Atazanavir 300 mg & Ritonivar 100 mg Tablets
  • Pediatric Fixed dose combination of Zidovudine 60 mg & Lamivudine 30 mg & Nevirapine 50 mg