HRV Pharma & Shodhana Laboratories Launch CDMO Alliance to Accelerate Next-Gen API Development

A key milestone in the alliance is the development and US Drug Master File (DMF) filing for a pharmaceutical-grade API described as a master coenzyme involved in cellular energy production, DNA repair, and ageing processes.

HRV Pharma and Shodhana Laboratories, Hyderabad-based pharmaceutical companies, have entered a strategic CDMO alliance to co-develop and commercialize next-generation APIs, marking a step forward in integrating virtual drug development platforms with high-precision manufacturing for global pharmaceutical markets.

The partnership comes amid growing interest in specialized APIs that go beyond traditional generics, particularly those aligned with precision medicine, oncology support, and neurodegenerative conditions.

In this collaboration, HRV Pharma brings its AI-enabled Virtual API Platform, regulatory expertise, and market access spanning over 50 countries, while Shodhana Laboratories contributes its capabilities in process chemistry, high-purity synthesis, and GMP-compliant manufacturing.

A key milestone in the alliance is the development and US Drug Master File (DMF) filing for a pharmaceutical-grade API described as a master coenzyme involved in cellular energy production, DNA repair, and ageing processes.

This molecule is increasingly being explored as a regulated therapeutic component in oncology supportive care, neurodegeneration, and longevity-focused treatments. With this filing, HRV Pharma positions itself as the holder of the first active Indian DMF for this specific API category.

“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,” said Hari Kiran Chereddi, MD & CEO of HRV Pharma.

“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,” said Nikhil Thota, Director of Shodhana Laboratories.

The alliance also includes a pipeline of five APIs targeting central nervous system disorders, rare diseases, and metabolic and neurological conditions, with identified customers in the US and Europe. Both companies will jointly oversee regulatory strategies, documentation, and validation processes under a milestone-based execution framework.

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