Glenmark Pharmaceuticals’ stock fell sharply by over 4% today following a series of recalls and potential USFDA regulatory actions concerning one of its manufacturing facilities in India. The Mumbai-based company has faced mounting scrutiny after multiple recalls of drugs due to improper dissolution, a defect that the USFDA has classified as potentially life-threatening, as reported by Pro Publica.
Key Developments:
- Glenmark Pharmaceuticals has faced seven recalls in the past year, all linked to dissolution issues at its central India facility. The most critical involved potassium chloride extended-release capsules, which could cause perilous potassium spikes.
- Since May 2024, the company has reported three deaths and other adverse incidents potentially linked to the defective potassium chloride capsules.
- The USFDA’s response to these recalls has drawn criticism for being delayed. Its last inspection of the implicated plant occurred more than four years ago, before the COVID-19 pandemic.
- The USFDA is under pressure to act swiftly amid concerns over its oversight of foreign pharmaceutical plants, especially those in India, which account for a significant share of generic drugs in the US market.
Market Reaction:
The pharmaceutical giant’s shares were trading at ₹1,465.50, down 4.53%, reflecting investor concerns about regulatory fallout and potential disruptions to US exports. Over the past year, Glenmark has shown impressive growth in its stock price, with a year-to-date rise of 72.32%, but today’s drop highlights the impact of escalating regulatory risks.
Regulatory Context:
The Glenmark recalls come amid broader criticisms of the USFDA’s oversight of foreign drug manufacturers. Congressional committees have called for more robust inspections, citing “institutional weaknesses” in monitoring foreign plants. The USFDA has declined to comment on specific ongoing compliance matters related to Glenmark but emphasized its commitment to safeguarding patient health through effective recalls and inspections.
