"From our inception, we've been committed to outstanding quality and unwavering integrity in all our operations and actions, beginning with creating a team of R&D experts with vast experience at the biggest and most respected pharma companies-both branded and generic."
Chintu Patel
CEO


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Research & Development

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.

Intellectual Property ⇒ Formulation ⇒ Project & Resource Planning

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.

Capabilities

Over time, we've progressed from rather simple formulations to the more complex such as controlled-release and suspension. Amneal opened its doors with oral solid dosage forms alone. Through acquisition, we moved on to also include liquids and soft gelatin capsules in our repertoire. Recently, we've expanded yet again with controlled substances as well as high potency and hormonal products. Injectables and topicals will soon follow with forays into new therapeutic categories and diverse delivery mechanisms.

Facilities

R&D, on the scale required at Amneal, requires thousands of square feet. Luckily, Amneal continues to grow in space. Through new construction and acquisitions, we've managed to expand our R&D realm from one facility to three in a surprisingly short time.

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.