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European regulators said they will reinstate a good manufacturing practice certification for Ranbaxy’s manufacturing facility in Toansa, India, following an inspection that found the generic drugmaker had addressed reported GMP violations. Read More
Inspections at beleaguered Indian generics firm Wockhardt’s Illinois plant have turned up quality control issues ranging from poor cleanliness to shoddy product testing and incomplete record-keeping, the FDA said. Read More
Distributors of active pharmaceutical ingredients in Europe should build quality management systems that include the same features as drugmakers’ QMS in areas such as contamination control and documentation, according to a new reference guide on good distribution practices. Read More
A federal judge rejected AstraZeneca’s motion to block generics from making versions of its inhaled corticosteroid Pulmicort Respules, and instead will consider that request and broader patent issues on the drug when the trial resumes this fall. Read More
A federal judge tossed out claims over a patent in Sandoz’s bid to launch a generic version of United Therapeutics Corporation’s pulmonary arterial hypertension drug Remodulin, but two more patent challenges remain. Read More
European regulators said they will reinstate a good manufacturing practice certification for Ranbaxy’s manufacturing facility in Toansa, India, following an inspection that found the generic drugmaker had addressed reported GMP violations. Read More
British drugmaker GlaxoSmithKline has agreed to pay $105 million to 44 states and the District of Columbia to settle allegations it engaged in deceptive marketing and sales practices on its asthma drug Advair Diskus and antidepressants Wellbutrin and Paxil. Read More
Drugmakers considering names for new products in Europe will have to narrow their options to just two proposed names under a revised guideline from the European Medicines Agency. Read More
Germany-based Sandoz has launched a generic version of Lundbeck’s antidepressant Cipralex in Belgium, France, Germany, Italy, Sweden and Switzerland, the generic firm said. Read More
The City of Chicago has sued five manufacturers of opioid painkillers, alleging the firms improperly marketed the addictive drugs for chronic, non-cancer-related pain management, a practice that elevated the city’s addiction rate and resulted in millions of dollars of unnecessary payments. Read More