Aurigene said the agreement sets out a full-service framework: The wider industry impact

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Hyderabad: Aurigene Pharmaceutical Services Limited, a wholly owned subsidiary of Dr Reddy’s Laboratories, Tuesday said it has signed a strategic long-term manufacturing and supply agreement with a global pharmaceutical company for commercial drug-product manufacturing across international markets.

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Aurigene said the agreement sets out a full-service framework covering technical transfer, process development, scale-up, validation, commercial manufacturing and long-term supply. Aurigene said the collaboration strengthens its contract development and manufacturing and contract manufacturing capabilities in drug products, especially sterile injectables and biologics, while complementing its wider pharmaceutical development and manufacturing services. Akhil Ravi, chief executive officer of Aurigene, said the partnership reflects confidence among global innovators in the company’s integrated drug-product development and manufacturing capabilities, quality and regulatory record, and ability to manage complex technology transfers and commercial supply.

The agreement covers a diversified portfolio intended for the United States, Europe, Canada and emerging markets. It did not, however, reveal the partner’s identity, citing confidentiality obligations. Aurigene operates as an integrated contract research, development and manufacturing organisation serving small molecules, peptides, biologics and sterile injectables from discovery through commercial manufacturing. Download the TOI App.

The initial portfolio includes more than 20 products across sterile injectables, biologics and topicals, which will be made at Aurigene facilities in India. At full commercialisation, the portfolio is expected to account for about 18 million units annually, mostly injectables. Revenue from the arrangement is expected to begin in year 2028.

The companies plan a phased technology-transfer programme over the next two to three years before commercial manufacturing and supply begin.

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