HRV & Shodhana team up to build next-gen API pipeline 

Key Highlights: 

• HRV Pharma has entered a multi-year CDMO partnership with Shodhana Laboratories to co-develop, manufacture, and supply a pipeline of high-science APIs, including longevity-focused molecules backed by a US Drug Master File (DMF) 

• The collaboration combines HRV’s AI-enabled Virtual API platform, global regulatory capabilities, and market access across 50+ countries with Shodhana’s expertise in process chemistry and GMP manufacturing, enabling end-to-end development, DMF filings, and commercialization across major global markets 

• The agreement includes development of a lead pharmaceutical-grade coenzyme API and a pipeline of five APIs across CNS, rare diseases, and metabolic disorders, positioning both companies to advance precision medicine and expand India’s footprint in high-value regulated API markets  

Implications: 

HRV Pharma is using the Shodhana alliance to turn its AI‑enabled “Virtual API” model into tangible, regulated assets, starting with a pharmaceutical‑grade longevity coenzyme backed by what it says is the first and only Indian US DMF for that molecule. 

By pairing HRV’s global regulatory/DMF engine and 50‑country access with Shodhana’s USFDA‑aligned process chemistry and GMP, the partners can take a pipeline of five high‑science APIs in CNS, rare disease and metabolic indications from development through multi‑region DMF filings, reinforcing India’s push up the value chain in precision and longevity‑focused APIs. 

Source: Express Pharma