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Alvotech Announces Completion of FDA Surveillance Inspection at Reykjavik Facility

Summary by WBOC 16
Company remains on track for BLA resubmissions in the second quarter REYKJAVIK, Iceland, May 11, 2026 (GLOBE

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Alvotech Announces Completion of FDA Surveillance Inspection at Reykjavik Facility

Company remains on track for BLA resubmissions in the second quarter REYKJAVIK, Iceland, May 11, 2026 (GLOBE

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Alvotech's share price has taken a nice jump this morning, after it was announced that the conclusion of an audit by the US Food and Drug Administration, FDA, was that the company now meets the strictest requirements for good manufacturing practices in pharmaceutical production.

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Alvotech plans to resubmit applications for marketing authorization in the United States for generic drugs before the end of this quarter. The U.S. Food and Drug Administration on Friday completed an inspection of the company's manufacturing facility in Reykjavík. The company's application for a license for the biotech drug AVT05 was rejected in November. At that time, the Food and Drug Administration had made comments about mold, puddles and st…

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Globe Newswire broke the news on Monday, May 11, 2026.
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