Glenmark bounces back with FDA approval and 15% revenue growth
Glenmark Pharmaceuticals has shown signs of recovery after a period of regulatory hurdles in the U.S. The company's Monroe manufacturing facility recently resumed production, following FDA approval. Meanwhile, its financial performance improved in the latest quarter, with revenues climbing by 15.1%.
The firm also received an ESG rating of 68 for the 2025 fiscal year, reflecting a growing focus on sustainability within India's pharmaceutical industry.
Glenmark's Monroe plant in the U.S. had faced prolonged shutdowns due to compliance issues. After securing a VAI (Voluntary Action Indicated) status from the FDA, the facility restarted commercial production. This marks a turning point for the company, which had previously struggled with regulatory setbacks, including a $55 million settlement in 2021 over price-fixing allegations.
In the third quarter of the 2026 fiscal year, Glenmark reported a 15.1% year-on-year increase in consolidated revenue. Its Indian formulations business performed particularly well, growing by 22.1%. These gains come as the company works to regain ground in North America, where its market share has remained flat at around 1-2% over the past five years.
While competitors like Dr. Reddy's, Sun Pharmaceuticals, and Cipla expanded aggressively in the U.S.—with annual growth of 15-20% in generics—Glenmark's progress stalled due to lost ANDA approvals and FDA scrutiny. Instead, the company has focused on innovation, securing FDA approval for novel respiratory treatments such as Ryaltris in 2022. However, its market capitalisation of around $3 billion still lags far behind peers like Sun ($40 billion) and Cipla ($15 billion).
The ESG rating of 68, issued by NSE Sustainability Ratings and Analytics Limited, highlights Glenmark's efforts to align with environmental and social governance standards. This trend mirrors a wider shift in India's pharmaceutical sector, where sustainability is becoming a priority for investors and regulators alike.
In the coming weeks, Glenmark's management will meet with investors at conferences in Mumbai and with Investec India. These discussions will likely cover strategies for U.S. expansion, sustainability initiatives, and long-term growth plans.
Glenmark's recent regulatory clearance and revenue growth suggest a gradual recovery after years of challenges. The company's ESG rating and investor engagements signal a stronger emphasis on sustainability and transparency.
Yet, with a market position still trailing behind key rivals, its ability to scale operations in North America and build a competitive pipeline will determine future performance.
