HRV Life Sciences, Haleos Labs Partner on Orphan Drug APIs

HRV Global Life Sciences, an integrated virtual API and pharmtech company, has entered a multi-year strategic development partnership with SMS LifeSciences—now Haleos Labs—a manufacturer of APIs and intermediates with a 25-year legacy of global quality and compliance.

The exclusive collaboration will focus on the development, scale-up, and GMP manufacturing of orphan-drug and niche-therapeutic APIs for regulated and semi-regulated markets. The partnership combines HRV’s global market access across 50+ countries and its digital, asset-light virtual API platform with Haleos Labs’ deep chemistry expertise, WHO-GMP compliant manufacturing systems, and proven track record in specialty API production.

Under the agreement, the companies will co-develop a multi-year pipeline of high-value specialty APIs, covering orphan, ultra-rare, and niche-therapeutic categories. The scope includes end-to-end GMP development and commercial manufacturing—from route scouting and process intensification to scale-up, validation, and global supply. Integrated regulatory strategies will support filings of DMFs across the US, EU, LATAM, MENA, and APAC, backed by comprehensive CMC, stability, validation, and technical documentation.

The partnership also includes an annual launch program, introducing 5–7 new molecules each year across rare diseases, CNS disorders, metabolic conditions, and other high-science therapeutic areas. A harmonized quality, compliance, and audit-readiness framework will ensure adherence to stringent standards set by regulators such as the US FDA, EMA, PMDA, and ANVISA.

The collaboration has already initiated five orphan/niche therapeutic programs, with additional molecules planned annually. Multiple US DMFs have been filed by HRV Pharma as part of this fledgling partnership. Both companies will jointly manage CMC documentation, stability studies, validation programs, and global regulatory interactions, creating a seamless pathway from development to commercialization.

This partnership reinforces HRV’s mission to build an AI-enabled, asset-light pharmaceutical platform and Haleos Labs’ ambition to become a preferred global partner for orphan, specialty, and niche therapeutic API development.

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