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Mylan warned by FDA over India drug plant's quality controls

[WASHINGTON] Mylan received a warning from US regulators for failing to ensure key drug ingredients made at one of its plants in India were not contaminated.

The Food and Drug Administration recommended Mylan chief executive officer Heather Bresch hire a consultant to help the generic drugmaker improve its manufacturing practices, according to an Aug 20 warning letter released Tuesday. Mylan's shares fell as much as 4.8 per cent.

The FDA inspected Mylan's facility in Pashamylaram, India, in February. The agency found the plant, which makes active ingredients for drugs, hadn't taken the proper precautions to ensure solvents it used didn't contain impurities, including failing to adequately test the raw materials.

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.

In July 2019, Mylan announced it would combine with Pfizer Inc's off-patent drug unit Upjohn in a deal that would reshape the generic drug industry. The merger is expected to close before year-end. Spokespeople for Mylan and Pfizer did not immediately respond to requests for comment, according to the warning letter.

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Mylan bought some of its solvents from an outside company that's been banned from selling in the US. Mylan testing showed signs of contamination, yet the company used the solvent in active ingredients intended for the US market.

Mylan has had similar violations in regard to solvents at another facility in India that the FDA warned the company about in November. The "poor control" of solvents led to contamination, according to the letter. The FDA redacted which drugs were contaminated.

"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. API's are active pharmaceutical ingredients.


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