A Chinese ingredient maker who has produced ingredients for some of the big guns in pharma including Novartis, Sanofi and Pfizer is getting its products banned by the FDA.
Wockhardt saw a new plant that will make sterile injectable drugs as its best shot at restoring a U.S. business devastated by FDA product bans. But the Indian company said today that facility--a plant it has called "one of a kind in Asia"--will not be shipping to the U.S. any time soon after the FDA found shortcomings during a recent inspection to judge whether it is fit for U.S. exports.
Perrigo is having to strip from retailers' shelves hundreds of thousands of packages of its copy of number-one allergy pill Zyrtec that are sold through CVS, Kmart, Kroger, and other retailers large and small. Perrigo initiated the recall of the antihistamine in late September after it found that the products potentially contained an impurity.
Cadila Healthcare last week got out in front of bad news by announcing it had received a warning letter from the FDA for two of its Indian plants but was doing all that was asked by the agency. What it didn't explain in the announcement is that it had yet to satisfy the FDA even after responding 15 times to FDA concerns, or that the FDA was particularly troubled by its manufacturing of the blood thinner warfarin.
Baxter has already faced some hurdles supplying saline solution, in October recalling nearly 140,000 bags of sodium chloride on mold worries. Now, it's recalling two lots of IV solutions after a customer discovered an insect in the product.
Takeda Pharmaceutical CEO Christophe Weber is in the midst of crafting the Japanese company's turnaround, and a piece of that effort is Entyvio, a drug he says should chip in $2 billion at its peak. Weber will soon have a new biologics plant in the U.S. devoted in large part to that drug that will help that effort.
The world's largest animal health company is moving forward with its pledge to become a little less large. In its second deal in two weeks, Zoetis will sell a production site and some of its products in India to Zydus Cadila as part of its pledge to close 10 plants and cut about 2,500 employees as it strives to improve margins.
Ceva Santé Animale is taking an active role in helping wipe out chlamydia in Australian koalas, donating supplies to animal health centers and one of the continent's top zoos to cure animals of the sexually transmitted disease.
Zoetis, under pressure from investors to shape up, laid out a sweeping plan earlier this year to eliminate 10 plants and about 2,500 jobs as part of an effort to flush out operating costs and improve its margins. But the animal health leader did not specify at the time which plants would have to go. Now it has provided its first peek at its intentions and it is starting with a three-facility deal with a Bulgarian firm.
Orlando, FL-based Nephron Pharmaceuticals is recalling more than 80,000 cartons of its over-the-counter asthma treatment, which it says have discoloration issues.