Product Development
Research & Development
Since its inception, Amneal has relentlessly pursued the most innovative and expert talent across a wide variety of products, dosage forms and delivery mechanisms. This has resulted in a Research & Development team that the company believes is without equal in the industry. The Amneal “Quality-by-Design” approach brings a level of consistent excellence throughout the development process and solidifies the bedrock of excellence behind each of its products.

Amneal scientists employ a unique formulation method and clinical study design allowing it to match bioequivalence across dosage forms and streamline the development process. This approach has delivered an unrivaled 100% success rate in scale-up.

Amneal invests in the absolute highest-quality facilities, equipment, technology and talent to ensure the seamless production of superb products.

Within multiple facilities distributed across New York, New Jersey and India, Amneal’s total annual production capacity is 16 billion today—growing to over 25 billion units in total capacity in 2015. These high volumes reduce all-in production costs and allows for price flexibility.

Vertical integration across API processing and distribution assures total control over quality, product availability. Manufacturing workflow design, equipment selection, and preventive maintenance assure uninterrupted 24/7 production.

Regulatory Affairs
Amneal takes enormous pride in meeting all regulatory statutes governing its products. Rather than limit itself to a position of compliance, Amneal works collaboratively with the regulatory agencies to pioneer new processes and advancements that elevate the entire industry.

At Amneal, compliance is far more than a requirement of doing business; it is a call to action that inspires the very best across the company as it continues its pursuit of product excellence.