Aurigene inks long-term manufacturing deal with global pharma company

The agreement covers technology transfer, process development, scale-up, validation, commercial manufacturing, and long-term supply across multiple markets.

Aurigene Pharmaceutical Services, a subsidiary of Dr. Reddy’s Laboratories, has signed a long-term manufacturing and supply agreement with an undisclosed global pharmaceutical company covering more than 20 drug products for the U.S., Europe, Canada, and emerging markets. The agreement will expand Aurigene’s commercial drug product manufacturing activities, particularly in sterile injectables and biologics.

The initial portfolio includes sterile injectables, biologics, and topical products that will be manufactured at facilities in India. The companies plan to conduct technology transfers in phases over the next two to three years, followed by commercial manufacturing and supply.

At full commercialization, the portfolio is expected to represent approximately 18 million units annually, with injectables comprising most of the volume. Aurigene expects revenue from the agreement to begin in 2028.

The manufacturing framework includes technical transfer, process development, scale-up, and validation before commercial production. Aurigene said the agreement builds on its existing drug product development and manufacturing capabilities.

The pharmaceutical company involved in the agreement was not disclosed because of confidentiality obligations, according to the announcement.

The agreement comes as parent company Dr. Reddy’s addresses a manufacturing issue involving its generic semaglutide. In July, the company said it had temporarily halted commercial production after certain batches were found to be out of specification because of an issue associated with the product’s active pharmaceutical ingredient. Dr. Reddy’s said it was investigating the root cause and would resume commercial supply following successful validation.

This piece was created with the help of generative AI tools and edited by our content team for clarity and accuracy.
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