When the FDA finds deep flaws at a manufacturing plant, it questions practices at all other facilities in the network. Hospira found this out in 2010 when a second warning letter in 8 months prompted the FDA to ask it to do a global review, and Wockhardt has now been given a similar regulatory to-do list.
When Wockhardt reported financial results in October, regulatory slapdowns in the U.S. and Europe made for a bleak quarter. Now, things are about to get much worse. The FDA has filed an import alert against the plant that generates 25% of Wockhardt's sales.
Generic drugmaker Mylan is recalling 73 lots and more than 480,000 bottles of the generic blood pressure medicine amlodipine besylate.
Sandoz, the generic drug division of Novartis, has pulled two batches of tuberculosis drugs from the market in India after some packages were found to have improper doses in strips of medications.
The manufacturing problems Japan's Daiichi Sankyo acquired when it took control of generic drugmaker Ranbaxy Laboratories have been one booby trap after another: warning letters, import bans, a consent decree and a $500 million settlement with U.S. authorities.
On Thursday, GlaxoSmithKline closed an oral healthcare plant in Clifton, NJ, that employed 270 workers and is shifting production to a facility in Oak Hill, NY. The closure is part of a phaseout that was announced in April 2010.
Manufacturing problems at a Sanofi Pasteur vaccine plant that the FDA savaged in a warning letter last year created such serious supply issues in the third quarter that the company was short vaccines in the U.S.--and so short revenues in the latest quarter.
The FDA banned products at Wockhardt's Waluj plant in May after inspectors discovered workers trying to hide significant problems with manufacturing and test data. The Indian drugmaker said at the time the import alert could cost it $100 million in lost revenues and is now starting to feel that squeeze.
Danish drugmaker Novo Nordisk is recalling 33 batches of insulin pens in the U.K. because of a manufacturing issue that led to a very small number of them having a very large disparity in their insulin fills.
India supplies the U.S. with 10% of its drugs and APIs, and some of India's largest drugmakers have felt the sting of FDA citations for quality lapses as the agency steps up inspections there. The Indian drug industry, in turn, gets 90% of its raw materials from China, but it has failed to open an inspection operation there despite that country's reputation for dumping low-quality products on India.