The headquarters of the US Food and Drug Administration in Silver Spring, Maryland. Credit: Reuters/Jason Reed.
The US Food and Drug Administration (FDA) warned pharmaceutical firm Mylan NV for failing to maintain quality standards at one of its plant in India that manufactures active pharmaceutical ingredients (APIs).
The FDA inspected Mylan’s facility in Pashamylaram, Telangana, in February. The regulator found the plant hadn’t taken the proper precautions to ensure solvents didn’t contain impurities and failed to adequately test the raw materials.
The FDA recommended Mylan chief executive officer Heather Bresch hire a consultant to help the generic drugmaker improve its manufacturing practices, according to an August 20 warning letter released Tuesday. Mylan’s share fell 5% to $15.55 at 1:44 pm in New York.
The regulator had in November observed similar violations at another facility in India with regard to poor control of solvents that led to contamination, according to the letter.
“These repeated failures at multiple sites manufacturing API demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” Francis Godwin, director of the FDA’s office of manufacturing quality, wrote in the letter.
Mylan said in a statement to Bloomberg that it had been working with the FDA since last fall to thoroughly investigate potential risks associated with inquiries related to impurities. The drugmaker, which is run from Canonsburg, Pennsylvania, said it put “additional controls, corrective actions and improvements in place” at the facility in question to mitigate perceived risk of product contamination several months prior to inspection.
Extensive testing of the APS “was performed for the presence of nitrosamine impurities and no evidence of cross contamination was identified,” according to Mylan. “We take very seriously our continued and comprehensive oversight of Mylan’s entire manufacturing network.”
Bloomberg reported in July 2019 that Mylan would combine with Pfizer’s off-patent drug unit Upjohn in a deal to reshape the generic drugs industry. The merger is expected to close before the year’s end. Pfizer declined to comment to Bloomberg at the time.
Mylan bought some of its solvents from an outside company that has been banned from selling in the US, according to the FDA. Mylan testing showed signs of contamination, yet the company used the solvent in active ingredients intended for the US market.
Solvents help in combining ingredients in the drug-making process. FDA inspectors reported that Mylan’s testing found signs of impurities in its solvents, but that the company failed to investigate further. Millions of blood pressure pills, including some made by Mylan, were recalled starting two years ago after they were found to contain chemicals that may cause cancer.
These incidents have been linked to drugmakers ignoring signs of impurities during testing.