FDA inspectors returned to a Wockhardt plant in Waluj that it banned in 2013 and weren't impressed by what they found during the weeklong inspection. New concerns were raised.
Sagent Pharmaceuticals 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 and Teva..
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While remediation costs continued to drag on the financials for Impax Laboratories last year to the tune of nearly $24 million, the drugmaker still saw some improvements in its financials for 2014 and finally bagged approval of its treatment for Parkinson's disease early this year.
The FDA has decided that not only were the operations of New Jersey-based Med Prep Consulting unsterile, they were illegal.
Pennsylvania-based Aprecia Pharmaceuticals this week announced its intention to purchase a never-used facility in Blue Ash, OH, built by Forest Laboratories in 2013.
The ability of Maine consumers to get cheaper drugs from across the Canadian border has been on-again and off-again. Now it is off again.
Two Indian vaccinemakers are ramping up production of their swine flu vaccines, to replace stocks that were destroyed recently after they expired.
The FDA has sent a Form 483 to Lupin listing 6 observations its inspectors made during a visit to one of the company's production plants in central India last month. However, the ticking off has done little to slow the rate of approvals for the facility, which has racked up two site transfer nods and one ANDA go-ahead since receiving the Form 483.
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Petaluma, CA-based Oculus Innovative Sciences announced Thursday that it has launched an animal health unit and 6 new products for the treatment of wounds, skin and eyes.
St. Jude Medical agreed to pay as much as $14.25 million to settle about 950 claims related to its Riata defibrillator leads. The wires used to shock a heart that is beating abnormally degraded in as few as four years and were pulled from the market in 2010.