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HRV Global Life Sciences, India's first integrated virtual API and pharmtech company, has inked a comprehensive, multi-year contract development & manufacturing partnership with Shodhana Laboratories Private Limited, a Hyderabad-based US FDA-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-commercialization pathway for molecules at the frontier of precision medicine.
Under the multi-year agreement, both companies will jointly execute the development and US DMF filing for pharmaceutical-grade API. This is 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.
There is 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. There is end-to-end GMP manufacturing, CMC documentation, stability studies and validation aligned to US FDA, EMA, PMDA and ANVISA standards. Global regulatory DMF filings are across US, EU, LATAM, MENA & APAC with HRV managing all regulatory interactions and expenses. Also a unified quality, compliance and audit-readiness framework for the highest tier of regulated market access.
Hari Kiran Chereddi, MD & CEO, HRV Global Life Sciences, said, "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. Shodhana's synthesis precision, combined with our global regulatory and commercial platform, means India can now supply this molecule at the quality level that drug development demands alongside a broader pipeline of high-science APIs that define where pharma is headed."
Nikhil Thota, Director of Shodhana Laboratories said, "Manufacturing pharmaceutical-grade API’s, and other products demands synthesis precision and quality systems at the highest tier of API chemistry. This is precisely where Shodhana excels. Partnering with HRV gives our pipeline the global regulatory infrastructure and commercial reach it deserves, and positions us at the forefront of high-science API manufacturing for regulated markets worldwide."
The partnership has already launched with five active development programmes, with both organizations jointly managing regulatory strategy and documentation under a structured, milestone-gated framework. This collaboration reinforces HRV's broader mission of building an AI-enabled, asset-light pharmaceutical platform and Shodhana's emergence as a preferred partner for precision and specialty API development at global scale, said the communication note.
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