At the Pharma Leadership & Innovation (PLI) Conclave 2025, held in Mumbai, Dr Abhijit Gothoskar, Technical Expert at Sigachi Industries, delivered an individual session titled ‘Nitrosamines and MCC’. His presentation addressed the critical role excipients play in maintaining pharma product quality while adhering to regulatory standards.
Dr Gothoskar focused on the increasing global concern around nitrosamines—impurities that present potential health risks. As regulatory authorities worldwide intensify scrutiny on nitrosamine levels, he stressed the need for manufacturers to proactively manage these contaminants to meet compliance requirements.
A key point of discussion was the importance of excipients, particularly in tablet formulations, in reducing the risk of nitrosamine contamination. Dr Gothoskar emphasised that excipient selection should prioritise chemical stability and purity, rather than focusing solely on cost and availability.
The session also highlighted Microcrystalline Cellulose (MCC) as a versatile excipient essential for the pharma industry. Known for its compressibility and binding properties, MCC plays a significant role in enhancing tablet integrity and stability. Dr Gothoskar illustrated how MCC has contributed to improved production efficiency and consistent tablet quality across batches.
Concluding the session, Dr Gothoskar positioned Sigachi Industries as a reliable partner for pharma manufacturers, offering both high-quality excipients and technical expertise to navigate regulatory challenges and ensure product consistency.