BBC Opioid Expose: FDA Suspends Aveo Pharmaceuticals’ GMP Certificate
The Food and Drugs Authority (FDA) has suspended the Good Manufacturing Practice (GMP) certificate of Aveo Pharmaceuticals, an Indian pharmaceutical company.
The Authority granted the company the certificate in September 2024 following an inspection in April 2024.
This is in response to BBC Africa Eye’s investigative report exposing the alleged exportation of unapproved drugs containing tapentadol- highly addictive opioids- and carisoprodol by the Indian-based pharmaceutical company through Westfin International, to West African countries including Ghana.
In a statement, the FDA said it “has also suspended Aveo Pharmaceuticals’ GMP certificate”.
Additionally, it says a directive has been issued to Samos Pharma- a Ghanaian importer of injections and eye drops which was fingered in the investigative piece- to cease using the two stakeholders’ service.
Per the FDA’s records from 2022 and 2023 Samos used Westfin International Private Limited and Aveo Pharmaceuticals as exporters of its products.
“In light of the BBC Africa Eye findings on Aveo Pharmaceuticals’ involvement in the illegal manufacturing and distribution of opioid products, the FDA has directed Samos Pharma to immediately cease using Westfin International Private Limited and Aveo Pharmaceuticals as exporters.”
Also, the regulatory body says it has suspended the processing of Masters Pharmaceutical Limited’s application using Aveo Pharmaceuticals as a contract manufacturer with immediate effect.
Source: opemsuo.com/Hajara Fuseini
