HRV Pharma, Heleos Labs form API development, manufacturing partnership

HRV Pharma, an India-based virtual active pharmaceutical ingredient (API) company, has entered into a multi-year strategic development partnership with SMS LifeSciences Limited—now operating as Haleos Labs—to develop and manufacture orphan-drug and niche therapeutic APIs, according to Express Pharma.

The exclusive collaboration will focus on development, scale-up, and GMP manufacturing of multiple specialty APIs for regulated and semi-regulated markets. Heleos Labs is an India-based manufacturer of APIs and intermediates with WHO-GMP-aligned production systems and more than 25 years of manufacturing experience, states the announcement.

Under the agreement, the companies will jointly develop a multi-year pipeline of specialty APIs including orphan and ultra-rare molecules, with end-to-end GMP execution spanning route scouting, process development, scale-up, validation, and commercial supply. The collaboration includes a coordinated global regulatory strategy, with drug master file submissions planned across the U.S., EU, Latin America, the Middle East, and Asia-Pacific regions, supported by chemistry, manufacturing and control (CMC), stability, and validation documentation.

The program is structured to introduce five to seven new molecules annually across rare disease, central nervous system, metabolic, and other niche therapeutic areas, supported by a harmonized quality and audit-readiness framework that meets U.S. FDA and EMA requirements. The partnership has launched with five initial orphan and niche API programs, and HRV Pharma said multiple U.S. drug master files have already been filed as part of the early phase of the collaboration.

“This collaboration accelerates HRV’s mission to build a next-generation, virtual API ecosystem that scales high-value, specialized APIs to global markets,” Hari Kiran Chereddi, managing director and CEO of HRV Pharma, said in a statement.

Both companies will jointly manage CMC documentation, stability studies, validation programs, and regulatory interactions to support a continuous development-to-commercialization pathway.

Separately, HRV Pharma also expanded its API development footprint through a multi-year CDMO alliance with Metrochem API Private Limited, focused on the development, scale-up, and GMP manufacturing of high-value NCE-1 and late-stage specialty APIs for regulated and semi-regulated markets. The partnership combines HRV’s virtual API platform, global market access, and regulatory capabilities with Metrochem’s process chemistry and GMP manufacturing infrastructure and launched with an initial pipeline of five programs.