News

FDA issued import alert after importer tried to ship saline not approved in U.S.

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.

GSK plans to unload site of closed Indian API plant

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 again recalls some Cubicin tied to contractor problem

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.

Hospira recalls 7 lots of propofol and one of lidocaine

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.

UPDATED: Novartis recalls some Ritalin over packaging issue

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 adds cell therapy manufacturing capacity with CSC buyout

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.

UPDATED: Bill for California statewide disposal law lands in the trash

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.

Counterfeits of Roche's Herceptin found in EU supply chain

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.

Novartis' Alcon opens $160M plant in Singapore

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.

U.K. starts work on $64M biologics manufacturing center

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.

UPDATED: FDA puts import alert on saline solution made at Baxter plant in Canada

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.

UPDATED: Impax believes manufacturing issues are fixed

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.

Plant that Patheon wanted to sell gets investment

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.

FDA tags yet another Indian drugmaker, Canton Labs, with ban

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.

UPDATED: Teva recalling more than 1M bottles of generic Cymbalta

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.

ViiV recalls 1,000 bottles of Tivicay for cross-contamination

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.

Lupin recalls more Suprax

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' government-backed vaccine plant should be operational by 2017

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.

AbbVie partners with Arabio for production in Saudi Arabia

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.

Sources: Sun has blueprint for turning Ranbaxy around

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.