After dealing with two preapproval inspections and two dozen FDA observations, injectables specialist Hospira says it has gotten FDA approval and is ramping up production at its new plant in India.
China's Zhuhai United Laboratories bills itself as the world's largest manufacturer of the API for the antibiotic amoxicillin. But the sterile manufacturing for some of its amoxicillin products has been called into question by inspectors in Europe, which is banning the sterile drugs for now, except in limited cases.
The FDA has three classes of recalls it can request or order, with class I recalls being the most serious. Those are for situations when there is a "reasonable probability" that use of what the agency refers to a as a "violative product" will have serious consequences and could be fatal.
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Novasep gained FDA approval last year for an expansion of its highly potent active pharmaceutical ingredients (HPAPI) capabilities at its plant in Le Mans, France. Now the French contract manufacturer is planning to build a facility there capable of manufacturing antibody drug conjugates (ADCs).
When a company isn't even familiar with common QC language, it raises red flags for inspectors. Add to that an indication that batch-testing records are riddled with errors and it is a recipe for a warning letter, which is what a South Carolina drug manufacturer has earned from the FDA.
TxCell, a French biotech working on T-cell treatments for chronic inflammatory and autoimmune diseases, named Stéphane Boissel as its new CEO in April. And one of the first issues Boissel gets to confront is regulatory concerns over a pilot manufacturing facility.
This year the FDA gave drugmakers, wholesalers and logistics companies an extra four months to get on board with new regulations requiring them to be able to track lots of prescription drug products all along the chain of custody. Now pharmacy groups are asking if they could catch a similar break.
When Akorn bought Hi-Tech Pharmacal a couple of years ago, CEO Raj Rai called the $640 million deal transformative. Most recently, what has transformed for Illinois-based Akorn is recalls tied to manufacturing issues at Hi-Tech.
Baxter has had a series of recalls in the last year, including more than 600,000 units of saline solution that it began recalling a couple of months ago. Now the company is voluntarily recalling a significant quantity of the blood thinner heparin.
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Celgene is paying about $1 billion to move to the front of the hectic race to build new CAR-T cancer therapies. The Big Biotech is shelling out $150 million upfront and paying $93 a share--a huge premium--to snap up 9.1 million shares of Juno Therapeutics, inking a collaboration to develop and commercialize new oncology therapies.
The FDA is putting increased focus on approving devices faster, as it races to catch up to its European Union counterpart. But University of Pennsylvania researchers were surprised to find that the agency is actually regulating devices appropriately, while European regulators are not.