Sept. 23, 2011 | Vol. 3 No. 38
American Regent has issued a voluntary recall of its vasopressin injection because some vials may not maintain potency throughout their shelf-life, rendering the product less effective.
Gyn Disposables violated GMP controls on design, material and production for the company’s intrauterine device (IUD) insertion and endometrial biopsy kits, an April 5-12 FDA inspection of the devicemaker’s Memphis, Tenn., facility found.
To ensure Japanese-made medicines carry no risk of radioactive contamination, European regulators are working with international regulators on tests running through Sept. 30.
Sun Pharmaceutical said its resolved the warning letter issued by the regulator for its facility at Cranbury, N.J. The regulator declared the site as an acceptable regulatory status, after its re-inspection in June 2011.
In separate deals, Pfizer announced an investment at its manufacturing facilities in Ireland, and the biopharmaceutical company Alkermes announced a multiyear, multimillion manufacturing supply agreement.
Belgian supplier Vésale Pharma has opened a production facility for the patent-pending probiotic microencapsulation technology it kicked into life at the start of the year.
Pfizer plans to cut its workforce in Spain by 11 percent, or 220 employees, because of the financial crisis in Europe and Spanish regulatory measures to reduce pharmaceutical spending, Expansion reported.
The previously announced job cuts at Merck will be completed by the end of next month. The layoffs in New Jersey and Pennsylvania — Merck has major operations in Montgomery County — will total up to 4,000 positions.
A $240,000 state development grant is expected to bring up to 32 new full-time jobs at the GlaxoSmithKline production facility in Hamilton by 2013.
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