The HIV-oriented joint venture of Pfizer, GlaxoSmithKline and Japan's Shionogi is turning to a Chinese manufacturer for a cheap supply of dolutegravir, the active ingredient in its Tivicay. The deal is seen as a way to cut the cost in China and some other developing countries of the JV's newest HIV fighter.
On Wednesday, the FDA announced a federal permanent injunction against a company that continued to sell suppositories after being repeatedly warned they needed to be evaluated and approved by the FDA. Separately, it warned makers of unapproved children's eardrops they may face prosecution if they don't stop selling them.
In April, Health Canada closed an active pharmaceutical ingredient repackager in Toronto and had it recall hundreds of bulk APIs that the regulators said could have been cross-contaminated by penicillin. Now the FDA has weighed in with a warning letter for the company.
Biogen said this week that it intends to build a $1 billion biologics plant in Switzerland. But the drugmaker expects the new EU facility to be just the first in a major manufacturing expansion that could result in two more new facilities as well as building up capacity at its existing sites.
Capsugel says it has completed the second phase of a $25 million project in Bend, OR, where it has built a spray-dried dispersion facility, which it claims is the largest in North America.
Actavis, which recently became Allergan, started in Iceland. Now the drugmaker, which is known for its cost-control strategies, is taking the job ax to its roots there. It plans to shut down a manufacturing facility, cutting 300 jobs in the process.
When Actavis, which is now Allergan, bought Forest Laboratories last year, it quickly set about whacking jobs. That included hundreds at operations on Long Island, NY. Now Canadian contract manufacturer Ropack says it will buy some of the discarded facilities to establish a U.S. beachhead.
Consultants tell Reuters that large Indian companies are heeding the warnings from regulators and investing more in equipment and training. But some small to medium-sized companies are considering whether to pour money into their operations, retreat from high-profit but regulatory-heavy markets like the U.S. and Europe, or cash out.
India's Dr. Reddy's Laboratories is having to recall both an epilepsy drug and a combo cardiovascular drug all made in India. One, the FDA says, is too strong while the other is not strong enough. The recalls come even as the FDA has been paying special attention to generic equivalence after testing has found evidence that some generics are not measuring up.
Several years ago, GlaxoSmithKline committed $50 million to set up an antibiotics facility in Singapore to do continuous processing, a radically different manufacturing approach that has a much smaller footprint, and so much lower operating costs and less environmental impact, than traditional batch processing. The drugmaker now says it is ready to embark on a £38 million expansion there.
This year the FDA gave drugmakers, wholesalers and logistics companies an extra four months to get on board with new regulations requiring them to be able to track lots of prescription drug products all along the chain of custody. Now pharmacy groups are asking if they could catch a similar break.
Novasep gained FDA approval last year for an expansion of its highly potent active pharmaceutical ingredients capabilities at its plant in Le Mans, France. Now the French contract manufacturer is planning to build a facility there capable of manufacturing antibody drug conjugates (ADCs).
TxCell, a French biotech working on T-cell treatments for chronic inflammatory and autoimmune diseases, named Stéphane Boissel as its new CEO in April. And one of the first issues Boissel gets to confront is regulatory concerns over a pilot manufacturing facility.
When a company isn't even familiar with common QC language, it raises red flags for inspectors. Add to that an indication that batch-testing records are riddled with errors and it is a recipe for a warning letter, which is what a South Carolina drug manufacturer has earned from the FDA.
After dealing with two preapproval inspections and two dozen FDA observations, injectables specialist Hospira says it has gotten FDA approval and is ramping up production at its new plant in India.
Baxter has had a series of recalls in the last year, including more than 600,000 units of saline solution that it began recalling a couple of months ago. Now the company is voluntarily recalling a significant quantity of the blood thinner heparin.
Russia's Generium has started construction in the Vladimir region on what is being billed as Europe's largest biopharmaceutical plant.
The FDA once again pitched in last week with other international regulators to crack down on illegal and counterfeit drugs being peddled over the internet. The FDA, Interpol and other authorities seized drugs, shut down some websites and made some arrests.
Canada's Pharmascience will expand facilities in Quebec and is getting help from taxpayers there to accomplish that.