HRV Pharma and MetroChem forge strategic CDMO alliance
November 18, 2025 | Tuesday | News
For GMP manufacturing of multiple high-value NCE-1 and late-stage complex APIs
Hyderabad-based HRV Global Life Sciences (HRV Pharma), India’s first integrated Virtual API and Pharmtech company, has announced a unique, comprehensive, multi-year Contract Development & Manufacturing (CDMO) partnership with MetroChem API, 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
The partnership includes a structured pipeline of five initial programmes, with additional molecules planned for development under a unified framework.
Both organisations will jointly manage CMC documentation, stability studies, validation programmes, and global regulatory interactions, creating a seamless development-to-commercialisation pathway.
