- FDA revokes Indian pharma company's GMP certification
- Aveo Pharmaceuticals accused of illicit opioid distribution
- FDA cracks down on opioid abuse, protects public health
The Food and Drugs Authority (FDA) has revoked the Good Manufacturing Practices (GMP) certification of Aveo Pharmaceuticals, an Indian drug manufacturer, for its alleged involvement in the illegal distribution of opioid-based medications to West Africa.
This decision follows an investigation by BBC Africa Eye, which exposed how Aveo Pharmaceuticals, in collaboration with Westfin International, allegedly exported unapproved drugs containing tapentadol and carisoprodol to Ghana, Nigeria, and Côte d’Ivoire.
These substances, classified as highly addictive opioids, present serious health risks, including respiratory failure and death when misused.
In response to the revelations, the FDA has instructed Samos Pharma, a Ghana-based importer, to cut all ties with Aveo Pharmaceuticals and Westfin International. Additionally, the regulatory authority has halted the registration process for six products from Masters Pharmaceutical Limited, which had planned to use Aveo Pharmaceuticals as a contract manufacturer.
Reaffirming its commitment to combating opioid abuse, the FDA highlighted its ongoing enforcement actions, including product seizures, fines, and legal proceedings against unauthorized drug distributors.
The FDA assured the public of continued collaboration with law enforcement agencies to prevent the infiltration of illicit pharmaceuticals into the country.
