TDB Supports Indigenous Manufacturing of Complex Pharmaceutical Excipients

In a significant move to enhance India’s pharmaceutical manufacturing capabilities, the Technology Development Board (TDB) under the Department of Science and Technology (DST) has announced financial backing for M/s Nitika Pharmaceutical Specialties Private Limited, based in Nagpur. The funding will support their project titled “Manufacture of Complex Excipients,” aimed at reducing the country’s reliance on imported pharmaceutical components. This initiative aligns with the government’s broader goals of promoting indigenous production and boosting the nation’s export potential in high-value pharmaceutical ingredients.

Importance of Excipients in Pharmaceuticals

Excipients play a crucial role in the pharmaceutical industry, despite being pharmacologically inactive. They are essential for the functionality, stability, and delivery of medications. As drug formulations evolve, particularly with the rise of complex generics and biopharmaceuticals, the demand for high-quality, customized excipients has surged globally. Currently, India, despite its status as a major player in the pharmaceutical sector, imports a significant portion of these complex excipients from countries such as the United States, China, and France. This reliance on imports highlights the need for domestic production capabilities to ensure the availability of these critical components.

Nitika’s Ambitious Manufacturing Project

M/s Nitika Pharmaceutical Specialties aims to establish a cutting-edge manufacturing facility dedicated to the commercial-scale production of 14 complex excipients tailored for advanced pharmaceutical applications. The project will adhere to the Quality by Design (QbD) framework, which emphasizes precision in various parameters, including surface area, particle size, and stability, to meet international standards. Established in 1991 and incorporated as a Private Limited Company in 2011, Nitika has built a reputation as a reliable global supplier of fine chemicals and specialty excipients. With a recognized in-house R&D facility and a presence in 90 countries, the company is well-positioned to make significant strides toward self-reliance in pharmaceutical auxiliary production.

Government Support and Strategic Alignment

The project is strategically aligned with the Government of India’s Production Linked Incentive (PLI) scheme for pharmaceuticals. M/s Nitika has been selected as a beneficiary under Group C – MSME (Pharmaceuticals), which underscores the government’s commitment to fostering indigenous manufacturing. The support from TDB complements the national mission of reducing import dependency and enhancing India’s export potential in high-value pharmaceutical components. This initiative is expected to not only strengthen the domestic pharmaceutical landscape but also contribute to the global health ecosystem.

Statements from Key Stakeholders

Rajesh Kumar Pathak, Secretary of TDB, emphasized the importance of domestic resilience in critical inputs like excipients. He expressed satisfaction in supporting Nitika’s project, which aims to bolster India’s position as a global leader in pharmaceutical manufacturing. Pathak stated, “This initiative will boost both Atmanirbhar Bharat and India’s capacity to support global health.” Meanwhile, the leadership at M/s Nitika Pharmaceutical Specialties expressed gratitude for the TDB’s support, reinforcing their commitment to developing world-class excipient solutions in India. They aim to leverage advanced infrastructure and a science-led approach to diminish the country’s dependency on imported excipients and establish themselves as a global leader in domestically produced pharmaceutical ingredients.

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