Production & Manufacturing
Production & Manufacturing
Janssen Submits Application to U.S. FDA to Expand Indication for Daratumumab
Janssen Biotech, Inc. announced a supplemental Biologics License Application (sBLA) for daratumumab (DARZALEX®) has been submitted to the U.S. FDA . The application seeks to expand the current indication, using daratumumab in combination with lenalidomide (an...
Production & Manufacturing
Agilent Chooses Colorado for New Pharma Manufacturing Facility
Agilent Technologies reports that it acquired 20 acres in Weld County in northern Colorado, on which it plans to build a pharmaceutical manufacturing facility. “The products manufactured at this site will be used by our customers...
Production & Manufacturing
Alexion issued new FDA Form 483 for Rhode Island plant
The FDA has again raised issues at an Alexion plant that three years ago was issued a warning letter. The facility is where Alexion manufactures what has been deemed the world’s most expensive drug, Soliris. Alexion...
Production & Manufacturing
Pfizer suspends work at Hospira India plant as FDA turns up heat
Pfizer is being schooled in the challenges of sterile drug manufacturing that come with its $15 billion buyout of Hospira. The New York drug giant has temporarily suspended production at a plant in India that the FDA cited three...
Production & Manufacturing
Aurobindo breaks ground on New Jersey facility
Aurobindo is starting to build on its pledge to expand operations in New Jersey, literally. The Indian drugmaker this week broke ground on the 567,000-square-foot facility that is slated to include a manufacturing and distribution center and warehouse, according...
Production & Manufacturing
Pfizer planning yet another plant expansion
In yet another expansion of its manufacturing operations, Pfizer ($PFE) plans to lay out nearly $150 million to build a sterile manufacturing facility and warehouse at its site near Kalamazoo, MI. It is the third manufacturing project the drug...
Production & Manufacturing
WuXi Biologics completes construction of Asia’s largest perfusion biologics manufacturing facility using disposable bioreactors
WuXi Biologics, a leading open-access R&D capability and technology platform company dedicated to biologics and a WuXi AppTec company, announced today the opening of a new commercial-scale cGMP biologics perfusion manufacturing facility in Wuxi city, China. ...
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