Facilities Overview
Our manufacturing site at Nanjangud, Mysuru, India is a state-of-the-art API manufacturing facility*, fully compliant with cGMP, quality & safety requirements.
This facility spans ~267, 700 square meters, and includes six multi-stream manufacturing blocks (multi-ton volume) and a pilot plant (up to 20 kg), offering volumetric capacity of ~785 KL. The facility is equipped with 20+ clean rooms and ~190 reactors ranging from 0.1 KL to 15 KL.
The facility employs an experienced team of over 900 personnel and is recognized for its expertise in complex chemistries, including chiral separation, low-temperature reactions, biotransformation, and stereo-selective synthesis. We are implementing various initiatives to streamline operations, enhance yield, and de-risk the supply chain, ultimately reducing costs and improving efficiency.
In close vicinity of manufacturing blocks, there is a dedicated R&D center & DoE/QbD cell to ensure product quality & process robustness, equipped with advanced instruments including LC-HRMS, NMR, XRD, LCMS, GCMS and ICP-MS. This integration facilitates seamless technology transfer, backward integration and complete control of production processes.
A new GMP kilo lab facility recently commissioned at the API manufacturing plant represents a cutting-edge hub for intermediate & API manufacturing, seamlessly scaling production from gram to kilogram quantities. The kilo lab is housed within the existing pilot plant, which is equipped with 24 reactors (50L to 500L), including a 0.2 litre coil reactor, centrifuges, VTD, RVD, Air jet mill, multi-mill and sifter. With an overall capacity of 50 L, the new GMP kilo lab can produce 100 grams to 2.5 kg material per batch, and is equipped to cater to the requirements of small-volume APIs for pre-clinical toxicology studies & clinical trials.
Our API manufacturing facility has been accredited by major regulatory agencies, including the U.S. FDA, PMDA, Health Canada, ANVISA,TGA and CDSCO India.
