Sun Pharmaceutical Industries

On August 01, 2024, Sun Pharmaceutical Industries Limited informed about a motion seeking a preliminary injunction filed in a US court to prevent the launch of LEQSELVI. On November 01, 2024, the US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI. As a result of the court decision, Sun is stopped from launching LEQSELVI until a subsequent favorable court decision or until the expiry of patent in lawsuit, whichever is earlier. The company respectfully disagrees with and intends to immediately appeal this decision.

Biocon Biologics

The U.S. Food and Drug Administration (FDA) has classified Biocon Biologics’ Drug Substance Facility at Biocon Campus, (Site 1) located in Bengaluru, Karnataka, as Voluntary Action Indicated (VAI).

This relates to the cGMP inspection conducted by the agency between February 20-28, 2024 and pertains to the supply of rh-Insulin (rhI) Drug Substance to the United States. Biocon Biologics remains committed to global standards of Quality and Compliance.