February 14, 2018 / 11:37 AM / 8 months ago

Bayer gets FDA rebuke for drug production in Germany

FRANKFURT (Reuters) - Bayer said it had received a warning letter from the U.S. Food and Drug Administration over how it handled production of some drugs at its Leverkusen, Germany headquarters.

FILE PHOTO: The corporate logo of Bayer is seen at the headquarters building in Caracas, Venezuela March 1, 2016. REUTERS/Marco Bello/File Photo

The German drugmaker, which is taking over U.S. seed maker Monsanto, is addressing the FDA’s complaints regarding manufacturing practices, which stem from a routine inspection in January, Bayer said.

It has no evidence that patient safety was or is at risk and no products would be recalled, it added.

FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo

“We expect temporary supply limitations affecting our mature product portfolio,” though distribution from the Leverkusen supply center would continue, Bayer said.

A spokesman said this was affecting the established drugs Adalat against high blood pressure, blood thinner Aspirin Cardio, antibiotic Avelox, and potency drug Levitra.

Citi analysts said in a research note that the products accounted for 2017 sales of about 2 billion euros ($2.5 billion), about 6 percent of the group total.

“The business impact will be reflected in our upcoming 2018 guidance on February 28,” Bayer said.

($1 = 0.8098 euros)

Reporting by Ludwig Burger; Editing by Arno Schuetze

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