The Seattle facility of AGC Biologics has received a Good Manufacturing Practices Certification from Agência Nacional de Vigilância Sanitária (Anvisa), Brazil’s health regulatory authority. The authorization allows biologics and biosimilars produced at the site to be commercialized in Brazil, the largest pharmaceutical market in South America, further extending the global reach of AGC Biologics’ customers.
“This certification ensures that our customers are able to deliver product to patients in need of treatment in the Brazilian market,” said Marty Shawala, Senior Vice President, Quality, AGC Biologics. “It reflects how our teams work collaboratively across departments and throughout the network to meet required quality standards and maintaining the business strategy associated with our customer’s regulatory submission.”