News

Indian API maker voluntarily halts shipments to the U.S.

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.

Feds extract guilty plea from Turkish man accused of smuggling counterfeit Avastin

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.

Out with the new and in with the old after GSK trips up at vaccine plant

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.

German Merck to start work on new China plant

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.

GSK, J&J push for genetic engineering of opium

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.

FDA again warns that Texas compounder's products may not be sterile

The FDA continues its battle with a Dallax, TX compounding pharmacy which it says is not meeting sterility standards.

FedEx to fight charges it was key link in supply chain for illegal drugs

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.  

American Health recalls epilepsy drug and ibuprofen over possible tablet switch

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.

Lilly to cut 100 production jobs in Indianapolis, but workers get shot at others

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.

FDA in search of a new head for its Indian 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.

Aptuit putting $1M into cytotoxic capabilities in Scotland

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.

Children's blood infections lead Teva to halt production of IV solution

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.

GSK recalls acetaminophen products that were not child-proofed

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 issues global recall of saline in midst of U.S. shortage

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.

J&J improves McNeil unit sales even as key plant remains closed for remediation

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.

Pfizer and Sun snatch up sterile injectable companies to boost expertise and capacity

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 cites Italian API maker for deleting all analytics

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 moves forward with $59M plant in North Carolina

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.

Forest, Hospira, West-Ward and Baxter recall products; Mylan gets two plants in deal with Abbott;

> The FDA discusses the steps it has taken to protect the the international supply chain. Blog > The U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA), has told medical...

Glenmark to build $100M plant in North America

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.