India's Aurobindo Pharma, in the midst of expanding its manufacturing targeted at the U.S., has gotten a production unit signed off on by the FDA. A second one, however, came up short of the finish line.
The drugmaker Monday said in a filing with the Bombay Stock Exchange that the FDA had done pre-approval inspections of two of its solid-dose units in India, approving one but noting observations for the second. No details were provided on the FDA concerns. The company said it was "appropriately responding."
The Hyderabad-based company last fall got approvals to start work on a 567,000-square-foot manufacturing, warehouse and distribution facility in East Windsor, NJ. It has not put a price tag on the investment but has said it expects to hire hundreds of workers when it is complete. At the time, the drugmaker said it had about 45 generic drug applications pending before the FDA.
Aurobindo also is in the midst of expanding in India, where it has half a dozen facilities but plans for more. Last summer, it announced plans to build an oral solid finished dosages facility at Naidupeta, an oral finished dosage facility in Visakhapatnam, and a semisynthetic penicillin plant at Jadcherla, near Hyderabad. It also is expanding the capacity of an API plant in Telangana, India.
In 2014, the drugmaker paid about $41 million to buy from Actavis facilities in France, Italy, Spain, Portugal, Belgium, Germany and the Netherlands. The deal included products, marketing authorizations and dossier license rights. They two also struck a long-term agreement for Aurobindo to provide Actavis with APIs.
- here's the BSE filing