BRASILIA: Brazilian drug regulator ANVISA has suspended import of active ingredients, used to make antibiotics, produced by pharmaceuticals major Lupin citing “unsatisfactory inputs” and deviation from good manufacturing practices (GMP).
In a statement posted on its website, ANVISA said it has suspended imports of “all beta-lactam cephalosporin pharmaceutical ingredients and all imported drugs using these inputs, which are manufactured by Indian company Lupin”.
“The analysis considered unsatisfactory inputs. Furthermore, irregularities were detected during the inspection for verification of Good Manufacturing Practices,” the statement said.
A Lupin spokesperson told PTI that the company exports only one beta-lactam API (active pharmaceutical ingredient) to Brazil.
“A few months ago, ANVISA, the Brazilian regulatory authority, had inspected our cephalosporin facility near Bhopal and had certain observations, which have since been addressed,” the spokesperson said.
One observation related to the plant manufacturing a beta-lactam API for veterinary use for supply to Europe, he added.
“While we don’t see this as a GMP concern, Lupin has confirmed to ANVISA not to manufacture API for Brazil in the plant referred above. ANVISA did not have concerns with Lupin using another plant at the same location to continue supply. We expect clearance from ANVISA to resume supply by September,” the spokesperson said.
In May this year, Lupin had announced acquisition of Brazil’s Medquimica Industria Farmaceutica, marking its foray into the Latin American nation.
Lupin shares, on Tuesday, settled 0.65 per cent lower at Rs 1,907.95 apiece on the BSE.
