The establishment of India's largest microcrystalline cellulose (MCC) excipient manufacturing plant in Nagpur, initiated by Nitika Pharmaceutical Specialities Pvt Ltd under the PLI scheme, has garnered significant attention for its potential to bolster both the domestic industry and export markets.

This state-of-the-art facility, set to serve 92 countries, will not only reduce India's dependence on imported excipients but also stimulate exports.

The newly established MCC manufacturing plant in Nagpur boasts cutting-edge technology and infrastructure, positioning it as India's largest and most advanced facility of its kind, with an impressive installed capacity of 1200 metric tons (MT).

During the event, Dr. Ravleen Singh Khurana, the Managing Director of Nitika Pharmaceutical Specialities, stressed that this accomplishment underscores Nitika Pharmaceuticals' dedication to quality, innovation, and eco-friendly manufacturing methods, establishing fresh benchmarks within the industry. The grand inauguration event not only represents a substantial achievement for Nitika Pharmaceutical Specialties Private Limited but also for the broader pharmaceutical and excipient manufacturing sector in India. It reinforces India's standing as the global "Pharmacy of the World."

Nitika Pharmaceuticals holds the distinction of being the first beneficiary of the Government of India's PLI scheme in the excipients category, with a total investment of $1,50,01,487.50 over five years. The government will incentivize the manufacturer based on a 10% annual incremental sales growth over the past five years. The company is WHO-GMP approved and specializes in manufacturing pharmaceutical excipients and lubricants.

Discussing their investment plans and future endeavors, Dr. Khurana disclosed that approximately $6000595 had already been invested in the plant over the past two years, with an additional $9000892.50 earmarked for the next three years. The company's goal is to produce high-quality complex excipients in accordance with Japanese and American Pharmacopoeias. Recognizing the untapped potential in top-end regulated markets, where most countries rely on low-grade excipient imports, Nitika Pharma aims to enhance the quality of complex excipients, focusing on functional related characteristics (FRCs). Their Research and Development (R&D) Center plays a pivotal role in achieving this objective effectively.

Dr. Khurana emphasized the importance of Functional Related Characteristics (FRCs) in complex excipients, encompassing qualities like particle dimensions, dispersion, surface coverage, flow characteristics, molecular mass, purity, compatibility, analysis, moisture levels, solubility, viscosity, density, and crystalline structure. Embracing the Quality by Design (QbD) approach, Nitika Pharma aims to evaluate FRCs and concepts that correlate with key formulation performance. In the QbD approach, quality is ingrained into the product and process through meticulous scientific design and understanding. This commitment to quality and innovation positions Nitika Pharmaceutical Specialities as a key player in India's pharmaceutical and excipient manufacturing landscape, with a promising future in both domestic and international markets.