ANVISA’s suspension order dated May 13 states the reason of its action as “analysis considered unsatisfactory
Reacting to news that Brazil’s nodal drug regulator ANVISA had suspended imports of all its beta-lactam cephalosporin APIs post an inspection a couple of months back, Lupin has issued a clarification that the observations on their cephalosporin facility near Bhopal have since been addressed.
ANVISA’s suspension order dated May 13 states the reason of its action as “analysis considered unsatisfactory. Furthermore, irregularities were detected during the inspection for verification of Good Manufacturing Practices.”
From the statement issued by the Lupin company spokesperson today, it appears that one observation pertained to the plant manufacturing another beta-lactam API for veterinary use for supply to Europe.
While the company does not see this as a GMP concern, it has confirmed to ANVISA that they will not make APIs for Brazil in the same plant. It has confirmed that ANVISA did not have concerns with Lupin using another plant at the same location to continue supply to Brazil.
The statement concludes, “We expect clearance from ANVISA to resume supply by September. There will be no impact on revenues.”
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