to Fast-Track High-Value NCE-1 API Development
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Hyderabad. HRV Global Life Sciences (HRV Pharma), India’s first integrated Virtual API and Pharmtech company, today announced a unique, comprehensive, multi-year Contract Development & Manufacturing (CDMO) partnership with MetroChem API Pvt. Ltd., one of India’s leading API development and manufacturing companies. This unique & first of its kind partnership focuses on the exclusive and semi-exclusive development, scale-up, and GMP manufacturing of multiple high-value NCE-1 and late-stage complex APIs for regulated & semi-regulated markets.
The collaboration brings together HRV’s global market access, commercial footprint across 50+ countries, and its digital, asset-light Virtual API platform with MetroChem’s deep process chemistry, scale-up capabilities, and robust GMP infrastructure.
Under the agreement, both companies will jointly execute:
Development and scale-up of multiple strategic APIs, including late-stage NCE-1 opportunities
End-to-end GMP manufacturing, validation, and supply for regulated and semi-regulated markets
Global regulatory DMF filings (US, EU, LATAM, MENA & APAC) with shared technical dossiers
A long-term, pipeline-led framework covering novel CNS, metabolic and specialty therapeutic APIs
A unified quality, compliance and audit readiness program designed for USFDA, EMA, PMDA, ANVISA and other key agencies
Speaking on this unique partnership, 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 for developing and commercializing high-value APIs with speed, quality and predictability.”
Harsha Nandepu, COO of MetroChem added, “Partnering with HRV aligns with MetroChem’s vision of moving deeper into complex NCE-1 and advanced API development. Together, we bring complementary strengths strong process chemistry, robust GMP operations, and HRV’s regulatory and global commercial reach. This partnership allows us to meaningfully expand our innovation footprint, monetize our R&D and deliver world-class solutions to global pharma.”
The partnership includes a structured pipeline of five initial programs, with additional molecules planned for development under a unified framework.
Both organisations will jointly manage CMC documentation, stability studies, validation programs, and global regulatory interactions, creating a seamless development-to-commercialization pathway.
This collaboration reinforces HRV’s broader mission of building an AI-enabled, asset-light pharmaceutical platform and MetroChem’s emergence as a preferred partner for complex and speciality API development at a global scale.