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Dr Reddy’s Delays Semaglutide Supply After API-Linked Batches Fail Specs

The move threatens confidence in fast-following generics, risking a shift toward manufacturers with proven peptide manufacturing controls.

Overview

  • Dr Reddy’s disclosed on Thursday that certain semaglutide batches were out of specification because of a problem tied to the active pharmaceutical ingredient, and the company said it is investigating with no reported patient-safety impact.
  • Torrent Pharmaceuticals issued a voluntary recall of select 2 mg and 4 mg Semalix injection batches that were manufactured by Dr Reddy’s and said other Torrent semaglutide SKUs remain unaffected.
  • Industry reports say at least three Indian manufacturers have initiated recalls or halted supplies over quality concerns, a development that hit Dr Reddy’s shares and follows signs that prescription growth had plateaued in June.
  • DRL management told analysts the issue stems from a process-linked problem during scale-up and said supplies could resume around October or November with a target of supplying 6–7 million pens in the second half of the year.
  • Semaglutide went off patent in India in March, which led to more than 50 generic launches and rapid price-driven uptake to about 82 percent of units by June, and clinicians are demanding clearer technical explanations as prescribers weigh reliability against cost.