A month after Hospira CEO F. Michael Ball acknowledged the company had more work to do to get its various manufacturing issues in hand, the company has recalled a product after hair was found in an injector.
Need the equipment to start a pharmaceutical manufacturing plant? Buy it this week for a one-time price of $2.2 million and the seller will also throw in the intellectual property for some insulin biosimilars. Otherwise it all goes up for auction.
The product has been approved in Ireland, the Netherlands, Sweden and the U.K., but the company said Thursday that Swissmedic had turned down the drug.
According to an FDA report, an internal investigation has tabbed the root cause as a manufacturing issue with an unnamed supplier. Cubist has called off all manufacturing with that supplier, and the Lexington, MA-based pharma won't resume production there until the supplier fixes problems and installs preventative measures. So far, the company has not received complaints related to the particles, the report says.
The contract manufacturing market should grow to about $18.5 billion over the next several years, driven in part by a demand for injectable drugs in general and specialized cancer drugs in particular. That, at least, is the view of consultants Frost & Sullivan.
Two more compounding pharmacies are voluntarily recalling products as FDA inspectors roll through the plants of the largest of those drugmakers and tag them for problems.
International Chemical Investors Group (ICIG) has nabbed another operation to fold into its contract manufacturing arm Corden Pharma group: Peptisyntha, a Brussels, Belgium-based custom manufacturer of peptides for pharmaceuticals. It will become its third site offering this service.
Novartis has repeatedly had to deal with issues at its over-the-counter operation in Lincoln, NE, and once again has been bitten by problems there. This time, the company is recalling more than 4.4 million bottles of Maalox from the U.S. and Canada because of problems with packaging.
The owners of India's Gujarat Research Allopathic Foundation (GRAF) Laboratories see a future in nutraceuticals and are building a plant to realize that vision.
The Department of Justice has filed a lawsuit on behalf of the FDA against Mitchell, SD-based Dakota Laboratories and its owner Charles Voellinger. The suit came after inspections in 2010, 2011 and 2012 found significant manufacturing lapses in the plant's production of eye drops.
Another drugmaker will get a government boost to expand so that an area can get new jobs in exchange. The Eastern Ontario Development Fund (EODF) did not specify how much in incentives the Pillar5 Arnprior manufacturing facility will receive but said the plant will add two production lines for manufacturing and packaging eye care products.
Chicago-area drugmaker Akorn has a lot of financial reasons to buy Hi-Tech Pharmacal, but there is a manufacturing angle in the buy as well; Hi-Tech has manufacturing expertise that Akorn wants to get its hands on.
Irish drugmaker Amarin continues to stack up manufacturing partners for the API for its fish oil drug Vascepa. While its decision to launch the drug without a partner has meant slow going in getting it to market, Amarin has pushed ahead with deals with contract manufacturers, hoping to get FDA approval for a fourth API maker.
Swiss contract manufacturer Lonza has been dealing with quality issues at its biologics plant in Hopkinton, MA, for a couple of years. And so in July, the company said it had decided to phase it out, eliminate 250 jobs and concentrate that work at a facility in Switzerland. The company says now most of those cuts will happen by the end of the year.
Just weeks after the FDA savaged a cancer drug plant in India for lying to investigators and hiding test results, it has received yet another warning letter, this time for problems at a Puerto Rico blood bag manufacturing facility.
Switzerland-based contract manufacturer Siegfried has decided to join those companies that are building in China, even as it expands other parts of its manufacturing operations.
An FDA warning letter to Indian drugmaker Posh Chemicals says that a quality-control chemist admitted during a March inspection that he "had recorded false visual examination data in the logbooks for reserve samples" at the order of a manager.
Walmart, Walgreens and Supervalu are all having their private label brands of the gastroesophageal reflux drug ranitidine hydrochloride pulled off of shelves after Indian generics maker Dr. Reddy's Laboratories found microbial contamination of some of the products.
The drug shortages that continue to plague healthcare providers also continue to provide opportunities for those drugmakers with the drugs that are needed. Jordan's Hikma Pharmaceuticals has again ridden shortages to higher profits, particularly a shortage of the antibiotic doxycycline.
According to Regeneron's recent quarterly financial filing, the company now has a preliminary deal to buy the 400,000 square foot facility in Limerick.