Aurobindo unit begins shipping drugs from India plant after FDA inspection triggered production halt

Aurobindo’s Eugia Pharma division has resumed shipping drugs from a plant in India that had to pause production in the wake of an FDA inspection.

Eugia’s Unit III facility, which is located near Hyderabad, India, had paused production to address certain FDA observations uncovered during an inspection last month. 

Previously, the company said it had restarted manufacturing on its "terminally sterilized" production lines at the plant. Now, the company has "started distribution of aseptic products" made there, Aurobindo said in a Tuesday filing (PDF).

“We also expect to start commercial production from the aseptic lines of the said facility in a phased manner beginning next week and to restart all the lines by April 15, 2024,” Aurobindo added.

Eugia's facility was recently slammed with a Form 483 that listed seven manufacturing observations.

That wrist-slap was preceded in January by the unit’s facility in New Jersey receiving a Form 483 in the wake of a December inspection. Since then, Eugia has agreed to sell the New Jersey plant.

Separately, Aurobindo released a shareholder presentation (PDF) that reports almost half of its $2.9 billion in profits through its most recent quarter ended in December were gained in the U.S., with 25% earned in Europe.

Aurobindo, which touts itself as the the largest generic drug maker in the U.S. based on prescriptions, said it produced more than 40 billion dosage forms in its fiscal year 2023. Globally, the company operates a total of 50 production sites and employs more than 33,000 workers.