HRV Pharma & SMS LifeSciences form strategic partnership for orphan and niche APIs

HRV Global Life Sciences, India’s first integrated Virtual API and Pharmtech company, has entered a multi-year strategic development partnership with SMS LifeSciences (now Haleos Labs) Limited, a leading API and intermediate manufacturer with 25 years of global compliance experience.

The collaboration focuses on co-developing, scaling, and GMP manufacturing high-value specialty APIs, particularly in orphan, ultra-rare, and niche therapeutic categories, for regulated and semi-regulated markets.

Key elements of the partnership include joint co-development of a multi-year pipeline of specialty APIs; end-to-end GMP development and manufacturing, from route scouting to scale-up, validation, and global supply; integrated regulatory strategy, including DMF filings across US, EU, LATAM, MENA, and APAC, supported by complete CMC, stability, validation, and technical documentation.

Hari Kiran Chereddi, MD & CEO, HRV Pharma, said: "Emphasized that the partnership accelerates HRV’s mission to build a Virtual API ecosystem capable of delivering specialized APIs to global markets with speed and regulatory depth."

Praveen Talluri, Executive Director, Haleos Labs, said: "Highlighted that the collaboration allows the commercialization of high-value APIs for rare and underserved therapeutic segments, leveraging both companies’ strengths in chemistry, manufacturing, and global regulatory expertise."

The partnership has already launched with five initial orphan/niche therapeutic programs, and multiple US DMFs have been filed. Both organizations will jointly manage CMC documentation, stability studies, validation programs, and regulatory interactions, creating a seamless development-to-commercialization pathway.