February 14, 2018 / 11:38 AM / 3 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.

“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)

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

Reporting by Ludwig Burger; Editing by Arno Schuetze

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below