Japanese drugmaker Kyowa Hakko Kirin, which develops its own drugs and is in a partnership with Fuji to make biosimilars, has completed construction on a new active pharmaceutical plant for biologics.
Indian authorities, who have been criticized for turning a blind eye to serious problems at Ranbaxy Laboratories plants there, have stopped a Ranbaxy API plant in Toansa from being able to sell products outside of India.
GlaxoSmithKline has said it will recall some batches of its antidepressants Paxil and Seroxat because the active ingredient used to make them might have been tainted. But the U.K.-based drugmaker didn't decide to take the step until it was publicly chastised by the FDA about the problem in a warning letter.
Making drugs requires ingredients--and that is what Ranbaxy Laboratories has been struggling with since the FDA banned its key active pharmaceutical ingredient (API) plant in January
The Global Alliance for Genomics and Health was thrust into the headlines last week when Google joined its ranks. This week it met for the first time to discuss its goals. Development of an open-source public application programming interface (API) for sequencing reads and genetic variants is high on the agenda.
Given that Indian drugmaker Ranbaxy Laboratories is under FDA sanctions for its manufacturing misses, a quarterly loss of $25.5 million may not sound so bad. But the January ban of a key API plant stands to make the current quarter worse, and competitors are looking for every opportunity to take even more business away.
Aurobindo has been looking to expand further in Europe, particularly in the sterile injectables business. With a €30 million ($41 million) deal to buy 7 Actavis active pharmaceutical ingredient facilities across Western Europe, the Indian company will be able to do that in one fell swoop.
The Ohm Laboratories plant in New Jersey is currently Ranbaxy's only facility able to turn out product for the U.S. market. Now the FDA has raised questions about manufacturing practices at the active pharmaceutical plant that supplies about 70% of the raw ingredients for U.S. production, Ranbaxy's facility in Toansa.
Many Western drugmakers are buying, building or partnering to establish manufacturing facilities in China. But Shenzhen Hepalink Pharmaceutical, one of China's largest raw heparin makers, has a deal to buy U.S. API maker Scientific Protein Laboratories.
The plan by Teva Pharmaceutical Industries to cut $2 billion-plus in costs leans heavily on making its manufacturing and supply chain more efficient. That restructuring has led it to back out on a new active pharmaceutical ingredient facility it was going to build in India.