)
On the Bombay Stock Exchange, the company's share price closed at Rs 1,875.70, down 1.69 per cent from the previous day. Even as the stock reacted, the company said the development is inconsequential in terms of the impact on revenue. Lupin also said it expects to resume supply by September from another plant with which the regulator had no concerns.
ANVISA, the Brazilian drug regulator said in a statement that 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 regulator added that the "analysis considered unsatisfactory inputs. Furthermore, irregularities were detected during the inspection for verification of good manufacturing practices," the statement said.
Confirming the development, a Lupin spokesperson said, "We export only one Beta-lactam API to Brazil. A few months back, ANVISA had inspected our Cephalosporin facility near Bhopal and had certain observations, which have since been addressed.''
One observation related to the plant manufacturing another beta-lactam API for veterinary use for supply to Europe, the company spokesperson said. ''While we don't see this as a GMP (good manufacturing practice) 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.
The company expects clearance from ANVISA to resume supply by September.
