Active Pharmaceutical Ingredients
Mylan Labs offers one of the industry's broadest and highest quality API portfolios and a robust pipeline to a global customer base in more than 80 countries. We service the requirements of top generic players in diverse markets with a wide portfolio of more than 150 APIs spread across variedtherapeutic segments.
We provide integrated solutions to API customers with support in early development, intellectual property support, drug master files submissions, query responses and timely commercial supplies for launch.Mylan Labs is an ideal partner for APIs due to:
- High quality products
- Multiple manufacturing facilities with accreditations from global regulatory bodies
- Robust pipeline with wide therapeutic range
- Speed to market capabilities
Mylan Labs has eight state-of-the-artAPI manufacturing facilities, certified by regulatory bodies like U.S. Food and Drug Administration, European Authorities, Australia's Therapeutic Goods Administration, Japan's Pharmaceuticals and Medical Devices Agency, Korean Food and drug Administration, and World Health Organization. Mylan Labs has diverse chemistry capabilities and over four million liters of reactor volume in a cGMP environment. This makes Mylan Labs one of the largest, high quality API manufacturers in the world.