Construction of a $150 million plant that Novartis is building near St. Petersburg in Russia has been halted because of "technical reasons," just short of completion.
In March, Sun Pharmaceutical recalled more than 2,500 bottles of its diabetes treatment metformin HCl after a customer reported finding an epilepsy pill in one. The company said it was investigating the issue, but apparently not to the satisfaction of the FDA.
While GlaxoSmithKline's new drugs Anoro and Breo have yet to take flight like the company had hoped, the drugmaker has been expanding the North Carolina plant where it makes them and other respiratory drugs, expecting that they will.
With Ebola rampaging through West Africa and now having reached the U.S., U.S. officials and the maker of an experimental Ebola drug manufactured from cells grown in tobacco leaves, ZMapp, want to expand the drug's current production while also seeing if traditional mammalian-cell methods might be used to quickly scale up production of the drug.
With four of its pharmaceutical plants in India banned from shipping products to the U.S., Ranbaxy Laboratories' U.S. operations have become essential to keeping product flowing into its biggest market. But with Ranbaxy's merger with Sun Pharmaceuticals getting close to closure, many of Ranbaxy's top U.S. execs are bailing out, putting some strain on its U.S. efforts.
CorePharma last year secured an FDA closeout letter for resolving the agency's concerns over its plant in New Jersey. Now that Impax Laboratories is picking up CorePharma and some sister businesses in a $700 million deal, CorePharma can share with Impax just how it managed to get that done.
Not all drug recalls track back to quality issues during manufacturing. A glitch in the supply chain can also come into play, and that is what happened with a lot of vancomycin hydrochloride injection being recalled by Hospira.
The FDA's crackdown on manufacturing plants has triggered German drugs packaging firm Gerresheimer AG to trim its financial outlook.
Vet drug company Ceva Santé Animale will begin shipping injectable drugs this week to China from a newly renovated and expanded plant at the company's headquarters in Libourne, France.
CSL Behring, a blood products specialist, said it will spend $450 million over the next few years to expand its production facilities in the U.S. and Australia.
Counterfeiters managed to get fakes of some of Roche's ($RHHBY) top-selling cancer drugs, including Herceptin and MabThera/Rituxan, into the European market this summer. This, among other issues, has motivated Roche's Genentech to have specialty distributors handle these recently conterfeited drugs, as well as Avastin. This decision has outraged some hospitals.
Kiran Mazumdar-Shaw, founder and managing director of India's Biocon, has had an interesting 36-year journey from brew master to biosimilars maker. She says her vision has always been for Biocon to affect global health in a big way.
Indian drugmaker IPCA, which has stopped shipping products to the U.S. and Canada from a plant in Bangalore, has acquired a high potency oral solid dosage facility from Alpa Laboratories.
Patheon, a contract manufacturer of drugs for pharmaceutical companies, plans to add 488 jobs over the next 5 years at its Greenville, NC, facility, and could eventually bring in more than $6.3 million in incentives offered by the state under a job development program.
Pennsylvania-based West Pharmaceutical, the maker of drug container components and drug delivery systems for injectable therapies, confirmed it will build a facility in Waterford, Ireland.
Sri Lanka, Yemen, Iran. India's Cipla is aggressively moving into markets that Western drugmakers often take a very long time to evaluate. It is using partners it already has to put together manufacturing deals that provide it ownership in local production.
Hospira has been dealing with FDA concerns for years for plants in the U.S. and more recently in India. But despite being told more than a year ago that it should have a "global corrective action plan" for both its foreign and U.S. plants, new issues have surfaced, this time for a plant in Australia that makes specialty injectable drugs.
Sagent Pharmaceuticals' business model calls for it to rely primarily on contractors to make the sterile injectable drugs that it specializes in. When a contractor has an issue, the effect dominoes to Sagent--a sequence of events that currently resulted in a recall of three lots of a nonsteroidal anti-inflammatory drug manufactured by India's Cadila Healthcare.
Boehringer Ingelheim has added a subproject to the expansion of its Respimat production plant in Dortmund, Germany.
The Ebola crisis has reignited interest in green, plant-based production of drugs and vaccines, but also highlighted a problem with the approach: There isn't much capacity. Officials in the U.S. are trying to find ways around the capacity bottleneck.