When an FDA warning letter derailed plans by Dr. Reddy’s Laboratories to get a copycat version of blockbuster cancer drug Gleevec to market, it turned to an outside contractor to help it out. Now, the Indian company said, regulatory problems with its substitute supplier may keep Dr. Reddy’s from getting to market this quarter with the hot commodity.
The disclosures came during an earnings conference call by the company, MoneyControl reported.
“It's an audit at our internal partner site that has derailed (the approval),” COO Abhijit Mukherjee said during the earnings call.
The company is evaluating its alternatives and might still be able to produce at its oncology formulation facility in Visakhapatnam if the facility passes a reinspection, which it expects to occur by the end of March, Mukherjee said.
The oncology plant is one of three that were named in a 2015 warning letter. At that facility, inspectors raised a number of issues about the potential for contamination in the way that employees handled vials. It also found that there were no standards to ensure drugs met specs for strength, quality, and purity and that employees were often not trained in how to determine which vials should be kept and which rejected. Dr. Reddy’s said it has invested $40 million to make upgrades at the plants.
India’s Sun Pharma had a 180-day exclusive for imatinib mesylate, the generic of the Novartis blood cancer drug, but because of FDA concerns over the plant where it was to produce the drug, had to shift production to another facility. A host of other of other generic drugmakers have filed for generics, including Cipla and Hetero.
Editor's Note: The story was updated to use the product name, Gleevec, which Novartis's product is called in the U.S. It is called Glivec outside of the U.S.