Abbott Laboratories said Monday it will establish its manufacturing bona fides by buying Russian drugmaker Veropharm and its four manufacturing plants.
The first phase of a big build-out by West Pharmaceutical Services in India is set to go online in about three weeks, the company confirmed today. It is the first plant for the supplier in India, a market that is poised to see significant growth in sterile injectables.
Carlyle Group, the private equity investors that sold off Japanese capsule maker Qualicaps to Mitsubishi, has picked up a new contract manufacturer, also based in Japan and one that also manufacturers capsules.
A guidance plan for this year from the European Medicines Agency GMP/GDP Inspectors Working Group outlines how the group plans to deal with centralizing inspections and achieving greater international cooperation on plant inspections.
Ranbaxy Laboratories, operating under the yoke of four FDA plant bans, has been unable to find a strategy that will allow it to launch three blockbuster for which it has exclusives. AstraZeneca's Nexium went off patent several weeks ago and Ranbaxy should have a generic on the market. That is because the plant where it makes the active pharmaceutical ingredient is banned from shipping product to the U.S. as is the plant where Ranbaxy was expected to make the formulated version.
Execs at India's Dr. Reddy's Laboratories recently highlighted how investments in plant upgrades had taken much of the human involvement out of drug production, but the improvements don't make production fool-proof. The drugmaker is voluntarily recalling a lot of generic Toprol XL as well as an unknown amount of an acid reflux drug it manufactured for someone else.
Grifols, the Spain-based specialist in blood plasma products, has opened a new plasma fractionation plant in the U.S. and says it has more plans, and money, for additional upgrades to its manufacturing network.
The World Health Organization says counterfeit and substandard antibiotics are getting into the global supply chain and creating resistance to treatments while fueling the emergence of so-called superbugs.
On Tuesday, the FDA posted a warning letter sent last week to Chinese ingredientmaker Tianjin Zhongan Pharmaceutical listing problems with keeping equipment clean and running down problems.
In April, the FDA banned a plant in Bangalore, India, owned by Canadian generic drugmaker Apotex. A warning letter sent last week and posted today by the FDA says that among other issues, it found that the company had deleted data of failed test results and then reported that the batches had passed.
Grand River Aseptic Manufacturing in Grand Rapids, MI has received an investment of $9.8 million from investors including the Municipal Employees' Retirement System of Michigan.
Earlier this year, Indian generic drugmaker Lupin picked up a Netherlands-based manufacturing specialist to extend its reach in sterile injectable drugs within Europe. The company, however, is not done buying capacity and capabilities throughout the continent.
Novartis' $1 billion influenza vaccine manufacturing plant in Holly Springs, NC, has just become the first pandemic-ready site FDA-approved to make cell-culture influenza vaccines. Now it needs to find a buyer for the facility.
A federal regulator has come down hard on an active pharmaceutical ingredient maker in Wisconsin, citing it for nearly two dozen violations, 7 that it calls willful, and recommending a fine of nearly $500,000. But the company, Fontarome Chemical, of St. Francis, WI, no longer operates.
Canada's Biolyse Pharma is back in business. The small company whose sole product is the sterile injectable cancer drug paclitaxel, said that Health Canada had reinstated it license after doing a follow-up inspection at its plant in St. Catherines, Ontario.
Teva Pharmaceutical Industries execs have said all along that reducing manufacturing and procurement costs from its vast manufacturing system will be key to cutting overhead by $2 billion by the end of 2017. Last month Teva CEO Erez Vigodman said it would close 11 and was looking at 16 more. Now Teva CFO Eyal Desheh said Teva intends to close about three dozen plants in the next four to 5 years.
Germany is implementing a system that allows the authenticity of drugs to be checked at the pharmacy level to protect against counterfeits.
Biosimilars are expected to be a big revenue generator for the companies with the expertise and the facilities capable to produce them. mAbxience, a Swiss-based subsidiary of a Spanish company, says it intends to be among those and has bought a competitor in Spain to move those ambitions down the road.
Having already bought the land on which Merck KGaA's salt plant in Lehrte, Germany, sits, salt maker Schüssler Novachem has now bought the production and laboratory equipment from the German drugmaker.
Federal authorities have torn down another pillar in a wide-ranging business that sourced foreign-made cancer and other drugs and sold them to U.S. doctors at a discount. Some of the meds were cold-chain drugs that were sometimes left unrefrigerated in Pakistan.