India's first virtual API platform enters longevity biology & precision medicine

HRV Global Life Sciences (HRV Pharma), India's first integrated Virtual API and Pharmtech company, has announced a comprehensive, multi-year Contract Development & Manufacturing partnership with Shodhana Laboratories, a Hyderabad-based USFDA-aligned API manufacturer, to co-develop, manufacture and supply a curated pipeline of high-science APIs, including pharmaceutical-grade API’s primarily used in longevity biology, backed by a US Drug Master File (DMF).

 

This makes HRV the holder of the first and only active Indian DMF in this product as a pharmaceutical API. The collaboration brings together HRV's global market access across 50+ countries, AI-enabled Virtual API platform and regulatory DMF engine, with Shodhana's deep process chemistry, high-purity synthesis expertise and GMP infrastructure creating a seamless development-to-commercialisation pathway for molecules at the frontier of precision medicine.

 

The partnership has already launched with five active development programs, with both organizations jointly managing regulatory strategy and documentation under a structured, milestone-gated framework.

 

Under the multi-year agreement, both companies will jointly execute:

• Development and US DMF filing for pharmaceutical-grade API — a master coenzyme governing cellular energy, DNA repair and aging, now emerging as a regulated therapeutic API in oncology supportive care, neurodegeneration and longevity medicine.
• A pipeline of five high-science APIs spanning CNS, rare/orphan disease, and metabolic/neurological API’s — with partner anchor end-customers across the USA and EU
• End-to-end GMP manufacturing, CMC documentation, stability studies and validation aligned to USFDA, EMA, PMDA and ANVISA standards
• Global regulatory DMF filings across US, EU, LATAM, MENA & APAC with HRV managing all regulatory interactions and expenses
• A unified quality, compliance and audit-readiness framework for the highest tier of regulated market access