Sagent brings production in-house after FDA finds fault with Indian CMO

Sagent Pharmaceuticals ($SGNT) has transferred production of atracurium besylate injection to its own plant after the FDA spotted GMP problems at the CMO that was manufacturing the drug. The FDA observations relate to aseptic practices at Emcure Pharmaceuticals, an Indian manufacturer behind earlier recalls by Pfizer ($PFE) and Teva ($TEVA).

Pune, India-based Emcure was responsible for last year's recall of almost 40,000 bottles of tablets by Teva. And in 2010, Pfizer was forced to recall 2,000 bottles of an animal bacterial infection drug manufactured by the company. Emcure's website still lists Pfizer, Teva and Sagent as clients, alongside Bristol-Myers Squibb ($BMY), Mylan ($MYL) and Novartis' ($NVS) Sandoz. However, Schaumburg, IL-based Sagent is now manufacturing atracurium besylate injection at its own facilities and has recalled 6 lots that were produced by Emcure.

The American Society of Health-System Pharmacists (ASHP) expects a slight supply blip during the rejig of production. Atracurium injection is now on the trade group's list of drug shortages, largely because it has been a problematic product for multiple manufacturers. Hikma Pharmaceuticals acquired an atracurium drug in its takeover of Boehringer Ingelheim's troubled Bedford Laboratories, but isn't actively marketing the product. And Hospira's ($HSP) output has been affected by manufacturing delays. ASHP expects Sagent to start releasing vials next month.

Neither the FDA nor Sagent has heard of any adverse events relating to the affected batches. But as with all sterility doubts regarding intravenously administered products, infections are a concern. Sagent is asking hospitals or wholesalers to quarantine and return the affected batches.

- read the release
- check out ASHP's page