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BREAKING- Impax Labs Halted- News Pending

Shares of Impax Labs (NASDAQ: IPXL) are halted for news pending.

According to Yahoo Finance:

Impax Laboratories, Inc., a specialty pharmaceutical company, develops, manufactures, and markets bioequivalent pharmaceutical products; and develops and markets branded products. The company operates through two segments, Global Pharmaceuticals Division and Impax Pharmaceutical Division. The Global Pharmaceuticals Division develops, manufactures, sells, and distributes generic pharmaceutical products through its global products sales channel for sales of generic prescription products directly to wholesalers, retail drug chains, and others; private label product sales channel for generic over-the-counter (OTC) and prescription products to unrelated third-party customers; Rx partner sales channel for generic prescription products through unrelated third-party pharmaceutical entities; and OTC partner sales channel for OTC products through unrelated third-party pharmaceutical entities, as well as offers research and development services.”

The $1.6 billion company is up about 11% in the past year.


Press release:

– Impax Laboratories, Inc. (IPXL) today announced that the U.S. Food and Drug Administration (FDA) performed a re-inspection of the Company’s Hayward, California manufacturing facility from June 16 to July 31, 2014. At the conclusion of the inspection, the FDA issued a Form 483 with seven inspectional observations, two of which are designated as repeat observations.

The FDA did not provide any status or classification to these observations and, pursuant to its established regulatory process, will defer classification until it has reviewed the Company’s response to the inspection. The Company is working diligently to address FDA’s observations and will respond to them within 15 days of receipt of the Form 483.

“Addressing these latest observations and advancing our quality improvement initiatives are our top priorities,” said Fred Wilkinson, president and chief executive officer of Impax Laboratories. “Our dedicated teams are focused on creating a world class quality organization.”

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