FDA inspectors have cited data manipulation and falsification at any number of manufacturing facilities in India, but a new warning letter for three Ipca Laboratories plants shows that it was rampant at that company, enforced by senior managers in the quality-control unit to keep product supply flowing.
Teva Pharmaceuticals' efforts to cut costs by making its manufacturing more efficient have landed at a plant in the U.K. where the generics leader will cut dozens of jobs but add some new positions with more specialized skills.
Novartis has rid itself of more than two dozen manufacturing sites in the past few years, closing or selling some facilities and handing off a bunch to GlaxoSmithKline as part of their big asset swap. Now the Swiss drugmaker says it intends to organize what is left into one overreaching operation in expectation of saving some serious money by 2020.
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Three of Dr. Reddy's Laboratories' key plants were singled out in a warning letter after FDA inspectors tallied up a host of data manipulation and contamination violations. But India's third-largest drugmaker was still able to grow sales in the U.S. last quarter even with production at the three facilities interrupted by remediation efforts.
India's Strides Shasun has been expanding and will add a seventh manufacturing site to its operations in Africa after buying controlling interest in a Kenyan drug producer.
The FDA intends to change the way it handles plant inspections, using metrics to suggest which plants may be having issues and making more frequent trips to those that appear at risk. While those companies committed to quality may be rewarded for their efforts, a new report warns that those that are already struggling with quality can expect to be more under the thumb of regulators.
Some drugmakers are expanding production in Africa to take advantage of a growing number of countries where rising incomes and national healthcare can pay for new meds. Now, through a number of sources of financing, a new plant will be built to manufacture yellow fever vaccine, a protection that has been in short supply.
A new report from CPhI of the U.S. market says that international API and drug manufacturers need to consider investing in U.S. manufacturing sites as drugmakers look to source products in the U.S. because of concerns over quality in some other countries.
It has been another tough week for some of India's troubled drugmakers. Wockhardt, which has two plants banned by the FDA, saw its hopes stymied for getting export approval for a different facility that it had hoped could help it recoup some of its lost U.S. revenues. And India's Ipca Laboratories, which has three plants on the import alert list, said Monday it has now gotten a warning letter for the facilities.
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The high-stakes rollout of Sanofi's dengue vaccine, Dengvaxia, is slated this month in the private market, the lead executive for the product said, adding that a tender for 3 million doses is in advanced discussions in the Philippines for a public launch within weeks.
After a follow-up review, the FDA has decided that the adverse events and deaths recorded in CTI BioPharma's pivotal program of the myelofibrosis drug pacritinib are so alarming that they've imposed a full clinical hold on the trial, halting dosing and persuading the biotech to yank its newly completed drug application.