Last year when Hikma bought Boehringer Ingelheim's Ben Venue injectable business, it decided not to reopen its long-troubled Bedford, OH, plant. But with a $2.65 billion deal announced today for Boehringer's Roxane generics business, it gets a U.S. manufacturing plant that it says it likes the looks of.
The European Union will impose a ban starting Aug. 21 on more than 700 drugs that were bioequivalency tested by India's GVK BioSciences after inspectors raised questions about its procedures.
Upsher-Smith had to quit shipping fluoxymesterone tablets last fall when its supplier quit making the API for Androxy. The problem was that Upsher-Smith is the only supplier in the U.S. for the drug, which is used to treat breast cancer in women and low testosterone in men. Now Upsher-Smith says Androxy is back.
Teva Pharmaceutical Industries voluntarily recalled 8 lots of a cancer drug a couple of months ago after rubber particles were found in some containers. Now the generics maker says the problem is more widespread than it first thought and more units will need to be retrieved.
Avista Pharma Solutions has snapped up the manufacturing, development and animal health services business from rival Scynexis in a move designed to bulk up its capacity and garner a larger share of the growing market.
After recalling 18 million vials last January of a painkiller commonly used in surgery, sterile injectables maker Hospira indicated that it was on top of the problem. But the company now says new manufacturing issues have cropped up that have led it to recall more than 20.7 million more vials of ketorolac, a drug on the FDA shortage list.
Ranbaxy Laboratories, which Sun Pharmaceutical recently acquired for $4 billion, has four plants in India that once produced products for the U.S. market. All four were banned by the FDA over the last 5 years for manufacturing and drug testing issues. But Sun may now only intend to spend the time and money to get three of them back to FDA standards.
Capsule maker and drug formulation specialist Capsugel has been beefing up its production capacities around the globe and will now turn its attention to a plant in Scotland that it picked up in 2013.
Swiss ingredient maker Lonza says its expansion in biologics manufacturing, including a new plant in the U.S., continues to build momentum and helped it realize revenue growth in the first half of the year. But costs at its massive operations in Visp, Switzerland, continue to be a drag and will result in the loss of more jobs there.
Patheon and its parent, DPx, have been on a buying and expansion binge since the company was created last year, grabbing up smaller CMOs to build out both capabilities and capacity. With an IPO in the works, more deals may be coming but the CDMO has ended up with operations that don't fit its model and is shedding those along the way, including two deals this week.
India's Lupin has landed its first manufacturing site in the U.S. with an $880 million deal to buy a small generics maker in New Jersey that specializes in niche products including dermatology controlled substances.
Novartis's generics business Sandoz provided the key bright spot in an otherwise tough earnings report for the Swiss pharma, with revenues up 10%. But the starring performance did not keep the manufacturing side of Sandoz from getting spanked, with three of its plants now targeted for closing.
Amgen's manufacturing and R&D sites in Colorado are officially on the block and the company is hoping another drugmaker will be interested in buying them.
When Biogen announced a few weeks ago that it intends to build a $1 billion new biologics plant in Switzerland, officials said the Cambridge, MA-based company had more manufacturing expansion up its sleeve. At least part of the great reveal was made last week when Japanese partner Eisai said it was turning over manufacturing operations in North Carolina to Biogen.
With its $800 million deal for Amoun Pharmaceutical, Valeant picks up what the Egyptian drugmaker says is one of the largest and most up-to-date pharmaceutical facilities in Africa and the Middle East.
With the completion of a spinoff July 1, Baxter International let go of most of its drug operations go with Baxalta while keeping its dialysis equipment, IV pumps and solutions, and injectable drugs and intravenous nutrition. In that category falls saline solution, and Baxter is again having to recall some of that; in this case, two lots because a customer discovered particulate that turned out to be insects.
Albany, NY-based contract manufacturer AMRI has continued its buying spree for more and more diverse manufacturing capacity, and the deals are getting larger. Its latest is a $174 million deal for a drugmaker in Spain that makes specialty APIs and sterile injected drugs.
Talib Khan is already doing time in federal facility in Philadelphia, but the FDA has let him know that once he is out, he is barred from ever working for any company that sells FDA-approved drugs.
GlaxoSmithKline has begun shipping its flu vaccine for the coming season after facing a string of issues last year that included receiving a warning letter for a flu vax plant and culminated with it pulling about 1.7 million doses of a vaccine from the market just a couple of months ago. But the British drugmaker says it is ready for this year and expects to ship up to 38 million doses of two flu vaccines, both formulated to protect against four strains of the virus.
The burden of recalling products manufactured at Wockhardt's two plants in India currently under FDA bans has fallen in part to American Health Packaging, a subsidiary of AmerisourceBergen, which has issued more than a dozen recalls of 6 products in different doses.