At Amneal, we are driven to conceive breakthrough developments. Dedicating 65 expert R&D professionals to the US market, it’s no wonder why many such advances stem from this department.

Amneal prides itself on an impressive regulatory track record. We were one of the first few companies to file an ANDA with the US FDA via its evolutionary eCTD/QbR/QOS (electronic Common Technical Document/Question-based Review/Quality Overall Summary) process. Using such innovative new methods paid off with our first eCTD approval secured in just ten months and ten days, and two more in less than twelve months each.

We were also the first company ever to secure FDA approval using the Bin-to-Hopper manufacturing process. And, with the recent completion of our 74,000 square-foot R&D Centre in India, we are poised to further expand our pipeline to include various dosage forms and complex formulations as well as manufacturing/API innovation.

The work of our R&D and Regulatory teams provides just the type of breakthrough methods needed to ensure the high-quality, cost effective products upon which Amneal is founded. Following is a brief look into some of their general responsibilities.

R&D Formulation:
Involved in the development of tablet and capsule products, the formulation development department enjoys significant experience in the development and scale-up of very sophisticated technologies including controlled release matrices and functional coatings. The department’s work also covers detailed development and characterization of blends for compression, compressed tablets, and coating procedures. Pilot scale equipment is used for the entire range of technologies, including blends for direct compression, slugging, and wet granulation.

AR&D:
The AR&D department performs all the evaluations of active pharmaceuticals to identify the source of API (Active Pharmaceutical Ingredient). In the evaluations, they do physical and chemical characterizations. This department also supports product development studies, and method development and validations with USP, ICH, and FDA guidance, as well as regulatory requirements for successful ANDAs and NDAs.

Regulatory Affairs:
Our Regulatory Affairs Department is responsible for preparing and submitting product submissions to the US regulatory body, the Food & Drug Administration (FDA). Regulatory Affairs communicates with the FDA to ensure that our products satisfy the necessary, and demanding, approval process before they reach the healthcare marketplace, as well as ensuring continued compliance post-approval.