Keeping pace with our aggressive growth strategy requires a prolific Research & Development team. Staffed by over 70 experts in the US alone, our exceptional scientific team provides Amneal with over 350-years of combined experience and scores of Ph.D.s.
Research & Development starts with our Intellectual Property team and their extensive due diligence, analysis, and product selection. From there, formulation experts design a production method unique to Amneal and our unyielding standards before project and resource planning kicks in. Here, our Quality-by-Design approach often translates into a more successful product scale-up. Quality-by-Design allows for a level of consistency throughout the development process that extends clear into the bio-equivalency studies. For instance, Amneal spends more time than is "normal" in the industry with in vitro testing replicating just how a compound will work in the human body. The reward is a scale-up of product that lacks many of the issues experienced by other manufacturers. Our scientific team's talent and methodology make Amneal enviably successful in the realm of bio studies.
New York: The core of our R&D efforts begin at this superb facility with its 40,000+ sq ft of labs. This location focuses on oral solids, controlled substances, hormonal, high potency and soft gelatin capsules (softgels) with an anticipated 12 or more ANDAs filed per year.
New Jersey: With an ideally outfitted R&D lab providing the tools and technology necessary to excel in liquids, sprays and injectables, Amneal's superb scientific team expects to annually file 10-12 ANDAs with the US FDA from this facility.
India: This state-of-the-art R&D Centre boasts 75,000 square-feet of pure R&D. Amneal develops over a dozen FDA ANDAs from this Centre annually across all dosage forms—all of which are to be filed from our US facilities.
Amneal Research & Development is the driving thrust behind our product growth initiative and long-term plan. By constantly finding ways to increase R&D capacity, we've significantly and rapidly expanded our development pipeline moving us nearer our target of 30+ ANDA filings per year.