FRANKFURT (Reuters) – Bayer mentioned it had obtained a warning letter from the U.S. Food and Drug Administration over the way it dealt with production of some medication at its Leverkusen, Germany headquarters.
The German drugmaker, which is taking on U.S. seed maker Monsanto, is addressing the FDA’s complaints concerning manufacturing practices, which stem from a routine inspection in January, Bayer mentioned.
It has no proof that affected person security was or is in danger and no merchandise can be recalled, it added.
“We expect temporary supply limitations affecting our mature product portfolio,” although distribution from the Leverkusen provide heart would proceed, Bayer mentioned.
A spokesman mentioned this was affecting the established medication Adalat in opposition to hypertension, blood thinner Aspirin Cardio, antibiotic Avelox, and efficiency drug Levitra.
Citi analysts mentioned in a analysis observe that the merchandise accounted for 2017 gross sales of about 2 billion euros ($2.5 billion), about 6 p.c of the group whole.
“The business impact will be reflected in our upcoming 2018 guidance on February 28,” Bayer mentioned.
($1 = zero.8098 euros)
Reporting by Ludwig Burger; Editing by Arno Schuetze