At Neiss, we have a dedicated & qualified team to handle various functions of regulatory affairs. Some of our identified strengths are:
A robust quality system facilitates both a Good Manufacturing Practice & a Good Business Practice. The well-organized quality system which is effectively managed, has resulted in consistent predictable outcomes. Amanta products are therefore reliable.
Being a cGMP facility, we strive continuously to determine proper implementation of good manufacturing systems & regulations through continuous training of the factory personnel. Our ceaseless efforts are directed towards maintaining highest quality standards. We continuously enhance our facilities, upgrade our technology and install new instruments as per 21 CFR.
Amanta concept of QA covers all matters that individually or collectively influence the quality of the finished product. These include:
The Companys R&D strengths are in developing intellectual property in the area of non-infringing processes and resolving complex chemistry challenges. In the process, Aurobindo Pharma is developing new drug delivery systems, new dosage formulations, applying new technology for better processes.
The R&D Center, in Hyderabad covers over 13,000 sq.m, and provides a nurturing environment to a multi-disciplinary team of over 700 scientists striving for excellence.
The Centre meets cGLP requirements, and is focused on the areas of organic synthesis, analytical research, dosage form development, pharmacology, bio-equivalence studies and drug delivery systems.
Process development lifecycles of less than three months, even if it involves complex multi step synthesis with multiple chirality.
Complete impurity profiling in all products developed.
Development of analytical methods and specifications from raw materials, to non-compendia finished products.
In-house synthesis of reagents for analyzing organolithiums and noble metals.