About an hour and a half west of Copenhagen is a little coastal town, Kalundborg, with 16,000 inhabitants, a famous five-steepled church and a castle dating back to at least the 14th century. It also happens to be the home of the plant that produces half of the world's insulin, the key component to most diabetes treatments.
Jordan-based Hikma several years ago evaluated whether to sell off its sterile injectable business and decided it was too valuable to give up. Now that part of its business is underpinning it growth and it is expected to do so in the future after it bought out a bunch of drugs and a huge plant in the U.S. from Boehringer Ingelheim.
Swiss-based CMO Lonza is cutting its tax liability here through the blessing of local economic development. It is not being required to return any of the tax incentives it got for a plant expansion after deciding to abandon a Massachusetts manufacturing site.
The drugmaker says it disagrees with the U.S. Consumer Product Safety Commission's allegations and is talking things over with the CPSC. But the Department of Justice is also investigating a complaint related to the same matter under the Federal False Claims Act.
The FDA in March issued an import alert against a Marck Biosciences sterile manufacturing plant in Kheda, India. A July warning letter posted today explains why. Employees recorded data for functions that were not performed. Records, if kept at all, were often put on "scratch paper." The bathroom was filled with mold and an exit loading dock was littered with dead and decaying frogs.
Fujifilm Diosynth Biotechnologies is adding a 2000-L single-use bioreactor at its plants in Research Triangle Park, NC, in the U.S. and Billingham in the U.K. to expand its cell culture manufacturing.
Sweden's Recipharm in April issued additional shares, preparing itself for expansion. Now the midsized contract and development group is putting those plans into play, buying an Italian company for more than $160 million, getting new business in Italy and emerging markets, as well as new capabilities.
French drugmaker Sanofi has released its first batches of a malaria treatment made from semisynthetic artemisinin using a new manufacturing process that will allow it to make tons of the ingredient and so help stabilize its volatile global market.
After releasing an earnings report that showed strong growth in the U.S., India's Sun Pharmaceuticals is recalling nearly 500,000 bottles of antibiotics, a fourth recall since announcing its $4 billion deal to buy compatriot Ranbaxy Laboratories and fix its ongoing quality faux pas.
When it comes to manufacturing, Big Pharma prefers traditional plants to living plants. While drugs manufactured from plants like tobacco have been in the news because several makers of Ebola drug candidates are using the process, the method has not been embraced by any of the major players.
After the MHRA hammered another SCM Pharma site for failing standards, the small CDMO came up short of cash to fix the problems and went into administration. Now Ireland's Shire, its largest customer, has taken over some operations to prevent interruption of production of an epilepsy drug it picked up with its acquisition of ViroPharma.
Amgen is recalling 9 lots of an anemia drug from 14 countries outside of the U.S. after syringes were found to have cellulose and polyester particles in them. The recall comes at a tough time for Amgen's manufacturing operations, which were just targeted for big cuts to prepare the company for future competition to a key product.
GlaxoSmithKline's plan of action for its troubled Quebec flu vaccine has gotten the thumbs up from regulator Health Canada, but that is only a part of the puzzle for meeting its contracts to produce tens of millions of doses of four-strain and three-strain seasonal flu shots for the impending season.
Baxter International, which has been scrambling to get added supplies of saline to the market in the midst of a national shortage, is recalling one lot of large-volume bags in the U.S. because of contamination.
India's Central Drugs Standard Control Organization has issued new guidelines for state inspectors on how to prepare for and handle inspections of drug manufacturing facilities, Regulatory Focus points out.
With two Indian plants on the FDA import alert list and a U.S. facility recently written up, India's Wockhardt reported this week that its April-June net profit was off 94% compared to the same quarter a year ago, producing 199.5 million rupees ($3.26 million), down from 3.23 billion rupees ($52.9 million) a year earlier.
The spotlight is back on Pakistani customs officials. With the force having previously been accused of accepting bribes to facilitate global counterfeiting operations, the Pakistani Federal Investigation Agency (FIA) has now indicted 76 customs officials as part of an investigation into the unlawful clearance of raw materials.
With the U.S. having the second highest proportion of immigrants to total population in the G8, people from overseas inevitably play an important role in many industries. But a study has found that immigrants are particularly vital to pharmaceutical production and distribution, with people born outside the U.S. accounting for more than one-quarter of the total workforce.
The number of recalls overseen by the FDA has surged over the past two years, Regulatory Focus reports.
In the 11 years since the Singapore government created a biologics CMO to kickstart the local sector, a who's who of biopharma manufacturers have opened plants in the country. Baxter is among the latest to set up shop in Singapore and is already pushing ahead with expansion plans.