Dec. 9, 2011 | Vol. 3 No. 49
Amid continuing concern that breaks in the global supply chain will beget another heparin crisis, FDA inspectors are upping scrutiny of drug and device manufacturers’ supplier controls to ensure they are sufficiently robust and clearly articulated in scientific terms, agency officials say.
Virtually all devicemakers surveyed by the FDA blame the agency in part for low-quality products reaching market.
Drugmakers need incentives from Congress and the FDA to create improved manufacturing methods that would help alleviate ever-increasing drug shortages, an industry expert tells lawmakers.
The FDA released a warning letter it sent to Novartis AG last month, which said the drug maker’s generic-drug unit so far has failed to correct repeated manufacturing violations.
Federal inspectors say the contract manufacturer for Johnson & Johnson’s cancer drug Doxil hasn’t been maintaining equipment or promptly investigating defective product batches and other serious problems at its Bedford, Ohio, factory.
Indian manufacturer of generic active pharmaceutical ingredients, Nectar Lifesciences, received European cGMP approval for its cephalasporin formulations manufacturing facility in the state of Himachal Pradesh.
AstraZeneca is all set to increase its footprint in China as the company took one more step in that direction recently by the acquisition of a Chinese generic injectable antibiotics manufacturer.
County commissioners on Tuesday voted to offer a five-year property tax abatement to an Alabama pharmaceutical firm eyeing a move to Okaloosa [Florida] County.
When the patent on Pfizer’s Lipitor expired, Ranbaxy Laboratories’ generic version was the first to hit U.S. drugstores, some 7,000 miles away from the northern Indian factory where the production process started.
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