- HRV Global Life Sciences has entered a multi-year strategic partnership with Haleos Labs to develop, scale up, and manufacture orphan and niche therapeutic APIs.
- The collaboration covers end-to-end GMP development, global regulatory filings, and a planned launch of 5–7 new specialty APIs per year.
HRV Global Life Sciences has announced a multi-year strategic development partnership with Haleos Labs (formerly SMS LifeSciences), focused on the development, scale-up, and GMP manufacturing of orphan-drug and niche-therapeutic active pharmaceutical ingredients. The agreement targets regulated and semi-regulated markets and is structured as an exclusive collaboration.
The partnership combines HRV’s global market access, commercial presence across more than 50 countries, and its digital, asset-light Virtual API platform with Haleos Labs’ chemistry expertise and WHO-GMP–aligned manufacturing capabilities. The companies will jointly execute a multi-year pipeline of specialty APIs, covering orphan, ultra-rare, and niche therapeutic categories, supported by integrated development and commercial manufacturing services.
Under the agreement, the partners will deliver end-to-end GMP development and contract manufacturing, from route scouting and process intensification through scale-up, validation, and global supply. The collaboration also includes a coordinated regulatory strategy, with drug master file submissions planned across the United States, Europe, Latin America, the Middle East, and Asia-Pacific, supported by full CMC, stability, and validation documentation.
The companies plan to introduce five to seven new molecules each year across therapeutic areas including rare diseases, central nervous system disorders, metabolic conditions, and other specialized indications. A harmonized quality and compliance framework has been established to meet the requirements of regulatory authorities such as the FDA, EMA, PMDA, and ANVISA.
The partnership has already launched with an initial pipeline of five orphan and niche therapeutic programs, with additional molecules planned annually. HRV Global Life Sciences said multiple U.S. DMFs have already been filed as a result of the collaboration, with both companies jointly managing CMC documentation, stability studies, validation programs, and regulatory interactions to support a seamless development-to-commercialization pathway.
