- HRV Global Life Sciences has entered a multi-year CDMO partnership with MetroChem API to accelerate development, scale-up, and GMP manufacturing of high-value NCE-1 and complex APIs.
- The collaboration begins with five pipeline programmes and includes joint development, DMF filings, and a unified quality and compliance framework.
HRV Global Life Sciences has formed a multi-year CDMO partnership with MetroChem API to accelerate the development, scale-up, and GMP manufacturing of multiple high-value NCE-1 and late-stage complex APIs. The agreement covers regulated and semi-regulated markets worldwide.
The partnership brings together HRV Pharma’s Virtual API platform and global market presence with MetroChem’s process chemistry expertise, scale-up capability, and GMP infrastructure. Both companies will jointly manage development activities, end-to-end GMP manufacturing, global DMF submissions, and programmes in CNS, metabolic, and other specialty therapy areas.
The collaboration also includes a unified quality and compliance programme designed to meet regulatory expectations from agencies such as the USFDA, EMA, PMDA, and ANVISA.
“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.”
Hari Kiran Chereddi, CEO of HRV Pharma
MetroChem API said the partnership strengthens its focus on complex NCE-1 and advanced API development. The press release states that the arrangement starts with five pipeline programmes and includes future plans for additional molecules.
Both companies will oversee CMC documentation, validation, stability studies, and regulatory interactions as part of a unified development framework creating an integrated pathway from early development to commercial supply.
