While a raft of India's largest drugmakers have had their shipments to the U.S. banned by the FDA over quality concerns, Ipca Laboratories has decided to do that on its own.
One of two men from Turkey that federal authorities accused of smuggling counterfeit cancer drugs to the U.S. labeled as gifts or documents has admitted he is guilty.
Problems with a new manufacturing process at the GlaxoSmithKline influenza vaccine plant in Canada caused some of the issues raised by regulators there, and so the U.K. drugmaker is reverting to its earlier process to get product to the market for the upcoming flu season.
Merck KGaA will start construction next month on a plant to make diabetes drugs in China, a market it says is key to its future. The market is so important that the executive board of the German drugmaker held an event there to reiterate that point to Chinese officials.
GlaxoSmithKline and Johnson & Johnson, which control most of the needed supplies for the industry, want authorities to approve genetic engineering so opium farming can be both expanded and made less susceptible to pests and so they can assure their customers they can keep up with demand.
The FDA continues its battle with a Dallax, TX compounding pharmacy which it says is not meeting sterility standards.
After its competitor UPS settled with U.S. authorities over accusations that it was a key link in the supply chain for Internet pharmacies, FedEx vowed to fight any charges that came its way. It will get the chance to do just that after the Justice Department filed charges against the international delivery service.
Another company is having to recall products because of packaging issues which could lead to serious health consequences for patients. This time the mix-up could result in patients getting ibuprofen instead of their scheduled dose of a seizure drug presribed for epilepsy patients.
Eli Lilly says about 100 jobs will be lost in its dry products operations as it rejiggers tablet and capsule production over the next several years, but that employees will have the chance to move to other positions, like in its growing insulin operations.
When India-born Altaf Lal was named to run the FDA office in India last year, he pledged to work with Indian drugmakers there to improve quality and their chances of avoiding regulatory actions by the agency. But someone else will have to take on that challenge because Lal has left after just about 9 months on the job.
Contract services company Aptuit will invest $1 million in its facility in Glasgow, Scotland, to expand its capacity to manufacture sterile cytotoxic liquid and lyophilized drug products.
Teva Pharmaceutical Industries, which in April had to recall a children's growth hormone, has now halted production of a parenteral nutrition product as the authorities try to determine why 9 children in Israel developed blood infections after taking it.
GlaxoSmithKline is voluntarily recalling four lots of its Panadol Advance product in 100-count bottles in Puerto Rico because the bottles do not have child-resistant packaging to protect against overdoses.
Baxter International has initiated a worldwide recall of three lots of sodium chloride as well as one of highly concentrated potassium chloride, the company announced today. The recall of the saline comes even as hospitals for months have been facing a shortage of the essential product.
Johnson & Johnson has managed a turnaround in its McNeil Consumer Health division by producing products like Tylenol and Motrin at facilities other than its still-closed Fort Washington, PA, plant and getting them back on retailer's shelves.
The sterile injectables business holds promise for drugmakers with the manufacturing capabilities to produce the difficult-to-make drugs. Deals announced Wednesday by Pfizer and Sun Pharma were proof positive of how companies think they can cash in on the generics piece of this sterile injectables market.
FDA inspections have uncovered a number of Indian companies that have manipulated data on their active pharmaceutical ingredients and deleted test results that didn't conform to specifications, an issue that has led to warning letters and contributed to import alerts. Many of those makers have been in India, but a warning letter posted today for an Italian company shows the problem is universal.
Purdue Pharma will build a new $59 million plant in Durham, NC, and has awarded a contract to KBR Building Group to erect the 188,000-square-foot facility.
Glenmark has more than a dozen manufacturing plants around the world, recently opening a mAb manufacturing facility in Switzerland to feed its pipeline of monoclonal antibodies and biosimilars. But the Indian generics maker does not have a plant in North America and figures it is time.