Aurobindo plugs $37M into biologics expansion as its vaccine arm looks to get in on the contract manufacturing action, too

After a rough regulatory start to the year, India’s Aurobindo Pharma is charting plans for growth.

The Hyderabad-based generics juggernaut will plow 3 billion Indian rupees (about $37.7 million) into an expansion of its subsidiary CuraTeQ Biologics, the company said Thursday.

At a director meeting this week, CuraTeQ’s board blessed plans to expand production with another mammalian cell culture manufacturing facility “of higher capacity to cater to ... future requirements,” Aurobindo said in a recent filing on the Bombay Stock Exchange.

The companies expect the plant to kick off operations in full by fiscal year 2026. The location and scale of the facility were not disclosed.

To capitalize on growing contract manufacturing momentum around the world—which the companies pegged at 8% to 10%—CuraTeQ says it will “actively seek customers in the CMO area.”

Further, the board of another Aurobindo unit, dubbed Auro Vaccines, approved exploring possibilities to offer contract manufacturing services targeting global vaccine developers, Medical Dialogues added in its own report on the Aurobindo expansion.

All told, Aurobindo boasts 27 manufacturing and packaging facilities across its production network, according to the news service.

Aurobindo’s had a bittersweet run in recent months, gracing Fierce Pharma reports on both the top 10 generic drug makers by 2021 revenue as well as its tally of the 10 worst FDA write-ups of the COVID-19 era.

Last year, the company ginned up $3.18 billion in generic drug sales, growing copycat revenues 7% over the $2.97 billion haul it scored in 2020. Taking a closer look at Aurobindo’s coffers, 88% of the company’s 2021 sales came courtesy of its formulations business, while another 12% came from sales of Aurobindo’s active pharmaceutical ingredients arm, which operates out of 11 manufacturing sites in India.

The company recently telegraphed its intentions to expand its portfolio to incorporate a wider range of medicines like drugs for cancer, inhalers, biosimilars, topical meds and patches, as well.

Still, it hasn’t all been smooth sailing for Aurobindo, which logged a January warning letter to start the year, followed by an FDA Form 483 in May.

The January letter referenced similar deviations to current good manufacturing regulations discussed at a regulatory meeting in 2019. Based on the repeated failures that were left uncorrected, the FDA strongly recommended hiring a consultant to assist the company and bring the facility up to par.

The May Form 483, on the other hand, cited six observations. At the time, the company said it planned to respond to the FDA within the stipulated timeline, which wasn't disclosed, and said it would work together with the agency to correct the observations.