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.
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 years ago with a warning letter after a new visit found ongoing problems.
Baxter in Manesar:
Baxter’s facility in Manesar, Gurgaon demonstrates excellence in manufacturing for the company’s Medication Delivery and Renal businesses, producing IV and PD solutions.