India's Jubilant Life Sciences has received a second warning letter this year for its operations in North America. This time, the company landed in hot water for problems at its Jubilant HollisterStier sterile manufacturing plant in Spokane, WA.
A Jubilant Life Sciences plant has joined a growing list of Indian drugmakers' facilities that have gotten crosswise with the FDA lately. But this time it is for a plant in the U.S., the second Jubilant plant in North America tagged by the agency this year.
This month, the FDA hammered a second Wockhardt plant in India, banning most of the products the generics drugmaker could ship to the U.S. A warning letter posted today shows that the plant was up to some of the same tricks that led the agency to its first ban earlier this year.
The boom years of the Indian pharmaceutical industry saw overseas businesses snap up Ranbaxy, Piramal Healthcare and a host of other firms, but consternation about the trend led some to try to curb such deals. Now though, with the Indian economy slowing, the government has thrown out the proposals.
There is growth in manufacturing sterile injectable drugs and a trend toward using prefilled syringes. India's Gland Pharma does both, and investment group KKR finds that an enticing proposition. KKR India has taken a minority stake in the drugmaker, investing $200 million, buying out the entire stake held by Evolvence India Life Sciences Fund.
Italian drugmaker Menarini is looking to grow its operations in India. It is bringing some new products to market there but would like to buy some established drug brands if it can find them at the right price.
Manufacturing facilities in India that are approved by Western regulators are a hot commodity, and that is what Bafna Pharmaceuticals has. The Indian drugmaker is for sale and is reportedly drawing interest from potential buyers, including Mylan as well as some Indian drugmakers.
Gilead Sciences' new hepatitis C drug sofosbuvir won preliminary backing from European regulators on Friday, with marketing approval expected to follow soon. The FDA is expected to clear the drug for take-off Dec. 8, if not sooner. All good for the California-based drugmaker. But there's a battle over sofosbuvir brewing in India.
Three of India's biggest CROs are joining forces to cash in on U.S. demand for outsourced drug services, launching a combined venture called Axcellerate Pharma.
Contract diagnostics outfit ResearchDx is making its way into India, counting on the boom in companion tests to drive demand for its services around the globe.