|
India’s largest microcrystalline cellulose (MCC) excipient manufacturing plant in Nagpur set up by Nitika Pharmaceutical Specialities Pvt Ltd under the flagship production linked Incentive (PLI) scheme will be a big boost for both domestic industry and export markets, said Guest of Honour Devendra Fadnavis, Deputy Chief Minister, Maharashtra while delivering his speech on the inaugural function of the new excipient plant in Butibori industrial suburb of Nagpur district recently.
Fadnavis further added that it is a big milestone not only for the region of Vidarbha but also for our key export destinations of Europe and America.
The Chief Guest of the function Union Minister for Road Transport and Highways Nitin Jairam Gadkari said that the new excipient plant which will cater to 92 countries will not only reduce import dependence for excipients but also boost exports going forward. “This will also pave India’s way towards growing as the third largest economy under Prime Minister Narendra Modi’s vision of self- reliant India.” The ceremony saw the participation of special guests and stalwarts including Ajay Sancheti, Sameer Meghe and Sandeep Joshi.
The new MCC manufacturing plant at Nagpur is equipped with cutting-edge technology and infrastructure, making it the largest and most advanced facility of its kind in India with an installed capacity of 1200 metric tons (MT).
Speaking on the sidelines of the event Dr Ravleen Singh Khurana, managing director, Nitika Pharmaceutical Specialties said, “It symbolizes Nitika Pharmaceuticals' commitment to quality, innovation, and sustainable manufacturing practices, setting new industry standards. The success of this grand inauguration ceremony marks a significant milestone not only for Nitika Pharmaceuticals Specialty Private Limited but also for the entire pharmaceutical and excipient manufacturing sector in India. This inauguration reinforces India's position as Pharmacy of the World.”
Nitika Pharmaceuticals is the first beneficiary of the Government of India (GoI) PLI scheme under the excipient’s category with a total investment of Rs. 125 crore for five years. Government will incentivize the manufacturer on the basis of 10% incremental sales annually over the past five years. The company is a WHO-GMP approved Manufacturing company that manufactures pharmaceutical excipients & lubricants.
Talking about the investment plans and the plans ahead, Dr Khurana informed, “Around Rs. 50 crore have already been invested in the plant in the past two years and another Rs. 75 crore will be invested in the coming three years. The company aims to produce high quality complex excipients based on Japanese and American Pharmacopoeias. There is a need to cater to the top –end regulated markets, which has a vast untapped potential as most of the countries rely on low grade excipient imports. Nitika Pharma has embarked on a journey to build quality in the complex excipients to produce quality formulations by focusing on the functional related characteristics (FRCs). Our R&D Centre is helping us to do that in an effective way.
Highlighting the role of FRCs in complex excipients, Dr Khurana explained that important physical chemical attributes affecting excipients functionality or performance are particle size, distribution, surface area, flow property, molecular weight, purity, compatibility, assay, moisture content, solubility, viscosity, density and crystallinity. Going by the quality by design (QbD) approach, we need to evaluate FRCs and concepts that are correlated with key formulation performance. In the QbD approach, quality is built into the product and process by design based on scientific understanding.
“Our aim is to build the biggest excipient complex of the world incorporating three new plants in the coming years in addition to the new facility and a state of the art innovation plaza. We aim to achieve ten times production capacity over the next five years,” Dr Khurana concluded.
|