HRV Global Life Sciences (HRV Pharma), India’s first integrated Virtual API and Pharmtech company, has entered into a multi-year Contract Development and Manufacturing (CDMO) partnership with MetroChem API , a leading API manufacturing company. This first-of-its-kind collaboration aims to fast-track the development, scale-up, and GMP manufacturing of multiple high-value NCE-1 and late-stage complex APIs for regulated and semi-regulated markets across the globe.
The alliance combines HRV Pharma’s global market access in over 50 countries and its digital, asset-light Virtual API platform with MetroChem’s strong process chemistry expertise, scale-up capabilities, and advanced GMP infrastructure.
As part of the agreement, the companies will jointly undertake the development and scale-up of strategic APIs, end-to-end GMP manufacturing, global DMF filings, and a long-term framework covering CNS, metabolic and other specialty therapy areas. The partnership also includes a unified quality and compliance program to meet stringent regulatory expectations from agencies such as the USFDA, EMA, PMDA, ANVISA and others.
Hari Kiran Chereddi, CEO of HRV Pharma, said, “This collaboration is a natural extension of HRV’s strategy to build a next-generation, Virtual API ecosystem that scales Indian innovation to global markets. MetroChem’s chemistry depth, combined with our global regulatory and market expansion engine, creates a powerful platform to develop and commercialise high-value APIs with speed and predictability.”
Harsha Nandepu, COO of MetroChem, added, “Partnering with HRV strengthens our efforts to move deeper into complex NCE-1 and advanced API development. Our combined strengths, chemistry expertise, robust GMP operations, and HRV’s commercial reach, allow us to expand our innovation footprint and deliver world-class solutions to global pharma.”
The partnership begins with five pipeline programs, with more molecules planned under the unified development framework. Both companies will jointly manage CMC documentation, validation, stability studies, and global regulatory interactions, creating a streamlined pathway from early development to commercial supply. |
