The FDA says the recent import alert imposed on 0.9% sodium chloride made at a Baxter International plant in Canada was issued because an "importer/consignee" tried to ship some into the U.S. The problem is, the saline made at that plant is not approved for sale in the U.S.
GlaxoSmithKline closed an aging active pharmaceutical plant in Thane, Maharashtra, India, a couple of years ago and let go of more than 300 people who worked there. Now, the British drugmaker would like to unload the property.
Cubist Pharmaceuticals has again been tripped up by one of its contractors, having to recall a single lot of its injectable antibiotic Cubicin because of particulate. The recall comes 8 months after a similar problem led it to recall four lots of the drug.
Sterile injectable drug maker Hospira last year ramped up production of the sedative and analgesic propofol, a drug CEO F. Michael Ball said he knew the market was anxious to see a bigger supply of. But the drugmaker is now recalling 7 lots of the drug because glass and metal particles have been found in some vial samples.
Attention deficit hyperactivity disorder drugs like Ritalin have been on the FDA shortage list for a variety of reasons. Now add to that packaging problems which have led Novartis to recall nearly 22,000 bottles.
NeoStem, the New York-based developer and manufacturer of cell therapies, will pick up another California plant with its all-stock acquisition of California Stem Cell, which it announced this week.
Drugmakers have so far been unable to stop an Alameda County, CA, law that requires them to pay for the disposal of unused medicines. They have managed, however, to dissuade lawmakers from making it a statewide requirement.
European authorities are warning that vials of Roche's cancer med Herceptin that were stolen in Italy are now showing up across the continent with little or none of its active ingredient.
With growing demand for eye drugs in Asia, Novartis' Alcon unit wants to have the capacity to sell into that market. To be able to do that, the company has opened a new plant in Singapore to make a variety of its eye drugs.
The U.K. is investing £38 million in its National Biologics Manufacturing Centre, part of the country's "High Value Manufacturing Catapult" effort started several years ago to increase its presence in biologics.
Baxter International, which has had a series of recalls in the last few months, has had a plant in Canada banned by the FDA from shipping products, including saline solution, which is already in serious short supply in the U.S.
Impax Laboratories had its future sidelined by manufacturing problems that set off a domino effect. Now, it says it is ready to get back in the game.
A U.K. plant that the former Patheon was ready to bail on two years ago will now get a $300 million shot in the arm. It and client Pacira will partner on manufacturing suites to provide additional capacity to produce Pacira's analgesic, Exparel.
The FDA sent a warning letter to Canton Laboratories in Vadodara, India, in February for a list of serious infractions, including falsifying data. The agency has taken the next step, issuing an import alert that bans products from the facility.
Teva Pharmaceutical Industries is one of half a dozen drugmakers that have been rolling out generics of Eli Lilly's top-selling blockbuster Cymbalta. The others are going to roll past the Israeli drugmaker after it recalled more than 1 million bottles of the antidepressant.
Tivicay, a combo HIV drug from GlaxoSmithKline, Pfizer and Shionogi that is pegged to become a blockbuster, was only approved last summer, but the companies are having to recall a small portion of it because of cross-contamination.
Rapidly expanding Indian generic drugmaker Lupin has stumbled, having to recall 5 lots of the antibacterial med Suprax (cefixime) because it failed purity tests.
Novartis' vaccine manufacturing site in Holly Springs, NC, is one of three backed by U.S. authorities which they can draft into service in the event of a pandemic. And it should be the first of the three to go online, according to a new report.
As growth has slowed in some emerging markets, Western drugmakers are looking to second- and third-tier emerging markets to gain momentum. The Middle East has become the new hot spot for pharma, and AbbVie has found its way there.
Sun Pharmaceutical execs acknowledge it will be no easy task to repair Ranbaxy Laboratories' damaged reputation with the FDA and the public. But Sun managing director Dilip Shanghvi and his lieutenants came in with a laundry list of actions to be taken quickly to jump-start the process, sources tell Reuters.