Aragen Life Sciences has begun operations at Aragen OneHP, a high-potency development and manufacturing platform at its Nacharam campus in Hyderabad. The platform adds capabilities for highly potent molecules, including cytotoxic payloads used in oncology, while providing customers with an integrated pathway from milligram-scale discovery through process development and multi-kilogram current Good Manufacturing Practice (cGMP) manufacturing.
Aragen OneHP spans approximately 15,000 sq. ft. and operates 1 manufacturing line with a designed capacity of 500 to 600 kg of Active Pharmaceutical Ingredient (API) a year. The platform can support highly potent compounds, including cytotoxic molecules and targeted Oncology therapies, and will lay the foundation for future expansion into advanced modalities.
OneHP will offer an integrated pathway from development through clinical and commercial supply worldwide, with manufacturing spanning small-scale chemistry synthesis (up to 10 g), non-GMP process development and scale-up (up to 500 g), and cGMP manufacturing (500 g to 5 kg per batch). Advanced containment systems are designed to handle compounds at occupational exposure limits of up to 10 ng/m³, subject to ongoing validation.
The platform is the most recent addition to Aragen’s continuous expansion program adding new capabilities. Aragen spent over INR 1000 crore on capital expenditure over the last 3 years to March 2026, building capability across small molecules and biologics. Its contract development and manufacturing business grew at a 19 percent compound annual rate over that period alongside a contract research arm that grew at 12 percent.
Installed small-molecule capacity stood at 364 KL across Hyderabad and Visakhapatnam as of March 31, 2026. The company drew nearly 95 percent of revenue from global customers in the year ending March 2026, and served 591 customers globally in that year, including 16 of the world’s top 20 big pharmaceutical companies.
Aniel Khubchandani, Chief Executive Officer–Small Molecules-CDMO, Aragen Life Sciences, said, “With OneHP, we are bringing discovery, development and cGMP manufacturing for highly potent molecules onto a more integrated platform. This can reduce handoffs between providers, while keeping process knowledge and program context connected as a molecule moves from early development toward commercial supply.”
Highly potent molecules, including cytotoxic compounds, require specialised handling, containment and manufacturing infrastructure. OneHP will bring together capabilities across small-scale chemistry synthesis, process development, scale-up and cGMP manufacturing, enabling customers to progress programs through an integrated platform. The platform also lays the foundation for the company’s future expansion into advanced modalities such as Antibody Drug Conjugates (ADCs) and Peptide Drug Conjugates (PDCs).
Aragen’s Hyderabad manufacturing and analytical operations are accredited by the US Food and Drug Administration (FDA), European Directorate for the Quality of Medicines and Health Care (EDQM), Pharmaceuticals and Medical Devices Agency (PMDA), Membership of the Faculty of Dental Surgery (MFDS), Agência Nacional de Vigilância Sanitária (ANVISA), World Health Organization (WHO) Geneva and Central Drugs Standard Control Organization (CDSCO).
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