India's Lupin hit by Brazil regulator suspension of antibiotic API

Lupin Managing Director Nilesh Gupta

India's Lupin Pharmaceuticals is under a suspension by Brazil's drug regulator on the import of active pharmaceutical ingredients (APIs) for beta-lactam cephalosporin because of a breach of good manufacturing practices. The suspension marks an awkward start to the company's presence in the country after buying Medquímica Indústria Farmacêutica in May.

Brazil's ANVISA said that APIs used to make antibiotics showed "unsatisfactory inputs" and deviated from GMP, according to a Press Trust of India story that appeared in the Business Standard. The original notice was issued in Portuguese on May 13, just as Lupin announced the purchase of the Brazil producer of branded, generic and over-the-counter drugs.

An English-language statement, cited by PTI, said ANVISA had 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.

PTI said Lupin exports only one beta-lactam API to Brazil and that the GMP issue had been cleared up.

"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," PTI said, citing a Lupin spokesperson. The spokesperson said one concern was the fact that Lupin was manufacturing a beta-lactam API for veterinary use in Europe.

"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."

- here's the Press Trust of India story carried in Business Standard
- and the ANVISA release (Portuguese)
- get FiercePharmaManufacturing's take