The FDA placed an import ban on products from Ranbaxy Laboratories' active pharmaceutical plant in Toansa, India, in January, calling into question its drug analysis and sanitation. But there are other problems at the plant, like worker safety, that the FDA does not address and which get little attention from Indian authorities.
GlaxoSmithKline, which is making big investments in manufacturing in the U.K., will help its homeland try to figure out how to revive its manufacturing base.
Eli Lilly and Chinese partner Novast have started on a new plant in China to manufacture generic versions of Lilly drugs, a bit of good news on a day when manufacturing issues had otherwise cast a shadow over the Indianapolis-based drugmaker.
Baxter International, which has had ongoing contamination issues with some of its intravenous products, is now recalling one lot of a peritoneal product used on dialysis patients. It says the lot is contaminated with mold. The announcement, also sent out by the FDA, says there have been adverse reactions reported.
Sterile injectables maker Sagent Pharmaceuticals is recalling a product because of leaking bags. It is the second recall in about 9 months for the company, which relies mostly on contractors to manufacture its products.
The FDA has held off approval of a new Eli Lilly diabetes drug until partner Boehringer Ingelheim fixes problems at a plant that last year was slapped with a warning letter.
Regeneron is starting work on a new manufacturing plant in Limerick, Ireland, that it expects to manufacture drugs that are currently in its pipeline. But already the drugmaker is talking about an expansion and building a fill-and-finish plant nearby, at least according to Ireland's minister of finance.
The global drug market is growing and by extension, so is demand for pharma packaging products.
Serving emerging markets generally requires local production--and that means investments in upgrades. That is the phase Eli Lilly is in with a packaging operation in São Paulo, Brazil.
Hospitals say the FDA and drugmakers should loop in hospitals and group purchasing organizations to attack drug shortages the way police would attack a hostage situation.
Germany's Fresenius Kabi has a grant from a state government in Australia and plans to build a new manufacturing plant there.
Jubilant Life Sciences says the FDA has given it a clean bill of health on a facility in Montreal, Canada, that was issued a warning letter in February 2013. The drugmaker has another facility in Spokane, WA, where the FDA still has concerns.
Another piece of U.S. pharma real estate has been sold. JPMorgan has bought AstraZeneca's research campus in Delaware for $44 million, according to the Philadelphia Business Journal.
Pfizer last year complicated a shortage of its hypothyroid drug Levoxyl when it tried a new manufacturing process. But manufacturing problems have been ironed out, and the company expects to have the drug back in consumers' hands by next week.
Generic drug maker Mylan turned itself into one of the largest makers of sterile injectable drugs last year with its $1.75 billion acquisition of Agila Specialties. Today the drugmaker pointed to one reason to take on all of that production capacity. Its earnings got a big boost from injectable products, in part because of drug shortages.
Bayer is joining the growing number of drugmakers expanding production capacity in China but in Bayer's case, it is doing it with an acquisition. The German drugmaker is buying one of the top makers of over-the-counter drugs and herbal medicines in the country and getting a number of plants in the process.
The FDA reported last week that for about 6 months it has been testing some generic drugs to see how they stack up to the branded products they mimic. That $20 million effort is laudable, but it isn't enough to ensure the generics that fill the medicine cabinets of U.S. consumers are both safe and effective, according to critics of foreign-made pharmaceuticals.
One tactic of U.S. authorities in fighting the onslaught of illegally imported and sometimes counterfeit drugs is to prosecute doctors who bought them knowing they came from outside the legitimate supply chain. A Missouri doctor whose practice, The Youthful Body, bought a foreign version of Allergan's Botox to get a deal is now going to jail for just that.
Pfizer is partnering with the Massachusetts Institute of Technology (MIT) to see if they can find new processes that will cut costs and increase efficiency, the Boston Business Journal reports.
One of the issues that the FDA has uncovered at several Indian drug manufacturing plants it has inspected is a penchant for messing with drug analytics to get the data companies need for drugs to be approved. Now the FDA has sent a warning letter to yet another Indian drugmaker accusing its analytics lab of making up sample weights used to test drugs, then using the results in FDA drug applications.