- HRV Pharma has entered a multi-year contract development and manufacturing partnership with Shodhana Laboratories to co-develop and supply a pipeline of high-science APIs.
- The collaboration includes five API programs, global DMF filings, and end-to-end GMP manufacturing aligned with international regulatory standards.
HRV Pharma has announced a multi-year contract development and manufacturing partnership with Shodhana Laboratories to co-develop, manufacture, and supply a pipeline of pharmaceutical-grade active pharmaceutical ingredients (APIs), including those used in longevity biology.
The collaboration brings together HRV Pharma’s virtual API platform, global market access across more than 50 countries, and regulatory DMF capabilities with Shodhana Laboratories’ expertise in process chemistry, high-purity synthesis, and GMP manufacturing infrastructure. The agreement is designed to support a development-to-commercialization pathway for APIs targeting areas such as oncology supportive care, neurodegeneration, and longevity medicine.
Under the partnership, the companies will jointly develop and file a U.S. Drug Master File (DMF) for a pharmaceutical-grade API described as a master coenzyme linked to cellular energy, DNA repair, and aging. The agreement also includes a pipeline of five APIs spanning central nervous system (CNS), rare and orphan diseases, and metabolic and neurological conditions, with identified end customers in the United States and Europe.
The scope of work covers end-to-end GMP manufacturing, CMC documentation, stability studies, and validation aligned with regulatory standards including the U.S. FDA, EMA, PMDA, and ANVISA. HRV Pharma will manage global regulatory filings and interactions across multiple regions, while both companies will operate under a unified quality and compliance framework.
“The API’s launch is not a wellness trend, it is the beginning of a pharmaceutical category. Filing a US DMF for pharmaceutical API’s is HRV’s signal that we are building for the next decade of medicine.”
Hari Kiran Chereddi, MD & CEO of HRV Pharma
