Botox is a sterile drug that has to be shipped according to strict cold-chain standards. But Syed "Farhan" Huda and his employees at Gallant Pharma International bought Botox and cancer drugs on the black market and sometimes received them shipped only with ice packs that melted before they arrived.
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.
Pfizer is shedding 150 employees at its facility in Newbridge, Ireland. The company says the cuts are needed as generic competition continues to eat away at its revenues. The move comes just two weeks after the U.S. drugmaker targeted a plant in Puerto Rico for closure.
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.
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.
FDA Commissioner Margaret Hamburg is slated to travel to India soon, and she will have lots to talk about--like all of the Indian plants the FDA has banned from exporting to the U.S. The agency Tuesday hit a second Wockhardt facility with a so-called import alert that prevents it from selling products into the U.S.
Pfizer's last quarter reflected ongoing drag from generic competition, and so the drugmaker keeps whittling away at costs where it can. The latest is its manufacturing operations in Puerto Rico, which have already been slimmed down in recent years.
Merck's manufacturing network continues to take a beating as the drugmaker acts on its $2.5 billion cost-cutting manifesto which is slated to claim 8,500 positions worldwide in the face of patent losses and revenue shortfalls. Next up, two facilities in Puerto Rico.
The investigation by Chinese authorities into of a host of drugmakers for bribery has put a chill on business there, but not frozen them in their tracks. Plans announced in the last two days by Johnson & Johnson and Merck KGaA to build new plants in China shows the market is too vast and too important to allow a little uncertainty to put plans on ice.
While other areas of its business have stumbled, Eli Lilly has been betting on diabetes treatments to help it pull through a bad patch. And like a gambler on a winning streak, Eli Lilly will double down on its investments in insulin production with expansions at plants in China, France, Puerto Rico and the U.S. This is after having doubled its bet earlier this year.