Toprol-XL Competitors Hampered by Production Issues

AstraZeneca is the only drug company manufacturing its former blockbuster hypertension treatment Toprol-XL because compliance issues related to good manufacturing practices (GMP) have hindered generic competitors. KV Pharmaceutical and Novartis’ Sandoz unit are the only companies that have FDA approval to manufacture generic Toprol-XL (metoprolol succinate). KV recently suspended almost all production because of GMP compliance issues. Sandoz received a warning letter last year questioning the validation process for its generic version of Toprol-XL.
Drug Industry Daily