Research & Development

In radiopharmaceuticals (till June 30, 2018), we are focused on high value niche products with diagnostic and/or therapeutic uses like successful 505(b)2 NDA approval by USFDA DraxImage® Exametazime and RUBY-FILL®. Another 505(b)2 NDA filing process for I-131 MIBG is ongoing along with 4 other products under development. We have our own in-house radiopharmaceutical distribution capabilities, thereby reducing our reliance on third party radiopharmaceutical distributors.

We also have a strong pipeline in our Generics and APIs business segment and since we commenced operations (through to June 30, 2018): for solid dosage formulations we have filed 95 ANDAs in the United States, of which 35 ANDAs are pending approval; For APIs, we have filed 93 DMFs in the United States. In addition, as on June 30, 2018, we have filed 12 ANDAs for sterile injectables, of which two ANDAs are pending approval in the United States.

We have R&D centers located in North America and India and, as on June 30, 2018, we employed a team of over 450 R&D professionals with expertise in the development of novel, robust and non-infringing processes for APIs and solid dosage formulations, as well as specialized and/or niche formulations and designs for radiopharmaceuticals and other products, which have been taken to commercialization. Our R&D continues to lead to new, innovative processes and new knowledge-driven products that increase the efficiencies of our production and allow us to capitalize on opportunities for growth in competitive markets. As on June 30, 2018, we have been granted patents for intellectual property in various countries for innovation, including 12 active patents granted relating to APIs in a number of different countries, 4 active patents granted relating to solid dosage formulations in a number of different countries, 81 active patents granted relating to radiopharmaceutical products in a number of different countries and 01 active patent granted relating to allergy therapy products in the United States.