Antibióticos do Brasil (ABL) invested R$180m ($46m) in the expansion of its site in Cosmópolis, Sao Paolo, which was made to expand production capacity and to minimise the risk of contamination.
Two new buildings were added as part of the extension, which increased the built area by 36,000ft2 and the overall size of the facility by 25%.
Investe Sao Paulo, which provided environmental and infrastructure advice for the project, said the updated plant would create approximately 150 direct and indirect jobs in the region.
“The whole range of equipment and concepts are unique in the production of sterile antibiotics because they reduce human contact with the product, ensuring greater manufacturing safety,” says Sidnei Bianchi Júnior, plant manager for ABL.
The updates to its sterile antibiotics production arrive two years after Italy outright banned the active pharmaceutical ingredients (APIs) produced at the facility.
The decision was made after the Italian Medicines Agency (AIFA) sent a team of inspectors to the facility, which raised concerns about good manufacturing practice (GMP) awareness and the quality control conducted at the site.
The US Food and Drug Administration came to a similar conclusion when it inspected ABL’s facility the year prior.