Lupin antibiotic products banned by Brazil

Lupin, which has been expanding its manufacturing and marketing footprint internationally via M&A, moved on Brazil in May with the acquisition of generics and OTC maker Medquímica Indústria Farmacêutica. But new markets mean new regulations, and the Indian company has been tripped by some issues that led Brazil to ban some of Lupin's antibiotic products.

On the same day that Lupin announced its deal for Medquímica, May 13, Brazilian drug regulator Anvisa posted its suspension of all imports of Lupin's "beta-lactam cephalosporin pharmaceutical ingredients and all imported drugs that were manufactured using these inputs." The agency said that analysis of the products found some issues and it was not pleased with some of Lupin's manufacturing operations.

A Lupin spokesman told the Press Trust of India (PTI) that one of the key concerns of Brazil's inspectors during a recent plant visit was the fact that Lupin manufactured a beta-lactam API that it sells for veterinary use in Europe in the same plant where it manufactures beta-lactam for human drugs. He said that the regulator had no problem if Lupin manufactured the API in another plant at the same site.

"While we don't see this as a GMP concern, Lupin has confirmed to Anvisa we will not manufacture API for Brazil in the plant referred above," the spokesperson told PTI. "We expect clearance from Anvisa to resume supply by September."

The Mumbai-based company has had other manufacturing issues this year. A plant in Pithampur near Indore that makes oral contraceptives as well as eye drugs for the U.S. market was cited with 6 observations by the FDA during a January inspection. The company didn't provide any insight into what kinds of manufacturing issues were uncovered, but the disclosure was part of an announcement about the FDA approving some drugs manufactured at the site.

Lupin Managing Director Nilesh Gupta

With its buyout of Medquímica Indústria Farmacêutica, Lupin now has manufacturing operations in Brazil, which is part of Managing Director Nilesh Gupta's plan to use M&A to grow internationally. He told shareholders in May that he intended to announce more deals this year. Then about a week ago, the company announced it was buying Russian generics maker ZAO Biocom, which gives it local manufacturing in that emerging market.

- read the PTI story
- here's the Anvisa release (translated from Portuguese)
- and here (in Portuguese)
- get FiercePharmaAsia's take

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