Navin Molecular to Invest Up to $35 Million to Expand GMP Manufacturing Capabilities

Navin Molecular recently announced a $35-million investment to construct a 9,000-square-meter GMP manufacturing plant in Dewas, India. The new facility will nearly double overall capacity at the site to 420 cubic meters, and will support existing commercial-scale projects, as well as meeting future demands as the company continues to expand its global customer base.

Multi-purpose in design, the facility will add 200 cubic meters of manufacturing capacity, using different vessel types including stainless steel, glass-lined, Hastelloy and Inconel. It will be capable of undertaking a range of chemistries, including hazardous processes such as direct fluorination, cyanation, azide chemistry, cryogenic reactions and high-pressure hydrogenation. The plant will include a high level of automated control, including a distributed control system (DCS), maximizing efficiency while reducing risks to employees and the environment.

Supporting the manufacturing infrastructure, the expansion will also increase the size and capacity of the site’s existing 21 CFR-complaint QC laboratory, to carry out in-process testing and final product release. A new process safety laboratory will be constructed, as well as a dedicated zero liquid discharge (ZLD) effluent treatment plant. Its construction will comply with India’s optimum green building concepts, leveraging modern technologies in materials, equipment and design, including renewable energy generation and solvent containment.  A ground-breaking ceremony took place at the site in April 2024, and the project is scheduled to be completed by the end of 2025 and will create up to 100 new jobs.

“As our business expands, we are progressing numerous projects to increase in scale towards commercial manufacturing, as well as investing in new, more advanced and niche technologies that we had previously identified as growth opportunities. Combined, this additional capacity and broadened technology platform will not only  satisfy these growing volumes, but will build for the future enabling us to capitalize on both horizontal and vertical market openings,” said Rajendra Kumar Sahu, Chief Executive Officer of Navin Molecular. “The new facility has been designed with sustainability at its core to minimize its environmental impact, while allowing us to continue to provide the highest quality, cost-effective manufacturing solutions for our customers.”

Navin Molecular was launched in 2023, and is the CDMO division of Navin Fluorine, focused on supporting global pharmaceutical innovators. Its 47-acre state-of-the-art site in Dewas offers process research and development through to commercial manufacturing of a wide-range of regulatory starting materials and API intermediates.

Navin Molecular is an Indian-headquartered CDMO, supporting its customers with world-class development and manufacturing capabilities, across a wide range of chemistries – with the ability to support projects from early-stage development through to commercial manufacturing. With extensive expertise in hazardous chemistries, including high-pressure, highly-energetic chemistries, direct fluorination and numerous additional competencies, it provides innovative solutions for the manufacture of complex molecules – and to cGMP standards as required. Its mission is to expedite customers’ programs through technology-driven development and manufacturing in a collaborative partnership model, whilst maintaining open and transparent communication at all times. For more information, visit www.navinmolecular.com.