Impax cited by FDA in manufacturing inspection


Fresh off dropping $130 million to license AstraZeneca's ($AZN) Zomig, drug delivery firm Impax Pharmaceuticals ($IPXL) faces a citation from the FDA for its manufacturing practices.

The company was cited last year for issues related to the production of fenofibrate, a high cholesterol treatment, resulting in a recall of 5 lots of the drug, FiercePharmaManufacturing reported. Now, the FDA says it found similar issues with the company's manufacturing of Type 2 diabetes drug Acarbose, citing Impax for reporting quality-control data that differed from its trial samples and conducting "unofficial and undocumented investigations" of the issue.

The California-based company specializes in controlled-release delivery and drug formulation, but has expanded to become a genericsmaker, finding some success with sales of generic Adderall in the first quarter of this year. The deal with AZ gives Impax the rights to market three versions of the migraine-treating Zomig, and the company will use the standard tablet, quick-dissolve pill and nasal spray formulations of the drug. Impax has reason for optimism: Zomig netted $163 million in the 12 months ending Sept. 30, 2011, according to Impax.

However, continued warnings from the FDA could hamper the company's efforts to profit off of generics. Impax's stock has fallen to around $21 a share after trading for about $27 a share at the end of April.

- read ​FiercePharmaManufacturing​'s report