The expertise to deliver high-quality, complex and cost effective APIs
At the heart of every medicine is the active ingredient. Accelerating access to innovative and affordable medicines begins with making active ingredients more affordable. Our relentless pursuit of innovation-led affordability helps our customers get access to the most complex active ingredients, while maintaining a consistent global quality standard.
Our API development efforts are driven by the twin goals of building our internal formulation expertise and supporting our global external customers. Our strong pipeline in synthetic chemistry, analytical chemistry and process engineering, supported by solid competencies in Intellectual Property Management, Regulatory Affairs, Supply Chain Management and state-of-the-art manufacturing facilities enable us to deliver sustained generics growth through world-class execution. Dedicated teams that focus on niche areas like sequential and random Peptides, Polysaccharides, Prostaglandins, Steroids, Oncology products, and other small molecules, give us a unique competitive edge in the development of APIs.
Advanced analytical tools and robust analytical methods are the hallmark of our product development program. Synthesis and isolations of genotoxic and process impurities are carried out using advanced Prep HPLC systems equipped with automated fraction collectors and flash chromatography. Characterization of API, impurities and reference standards are done using NMR, LC-MS/MS, GC-MS and HRMS among other advanced techniques.
The Process Engineering team plays a critical role in the development of robust processes. They do this by engineering process conditions that ensure consistency in operations and product quality and maximizing yield in reactions, while minimizing loss of yield in further downstream processes. Process and Product Safety are given a very high priority during the development and manufacturing phases. Extensive testing ensures safety of the personnel working on the product and machinery.
Technology is an active area of work in the new product development program. This team works on new technologies such as continuous plug flow reactors, PAT tools for on-line monitoring of processes, membrane and RP-HPLC systems for purifications, sono-crystallization and in-line homogenizers for particle size control among others. Developing an eye for new technology and working with worldwide technology experts not only gives our scientists exposure to the techno-commercial world, but also helps in establishing alternate technology options for our existing processes.