Biocon and 2 other pharma stocks fall after USFDA sees issues in its manufacturing facilities

Synopsis:- Pharma counters remained under focus as USFDA inspections led to multiple Form 483 observations, pressuring near-term sentiment, while a global biosimilar settlement unlocked launches. Stocks traded marginally lower, with declines of under 1%, reflecting regulatory caution alongside long-term growth optimism.

Regulatory developments and strategic global agreements have brought renewed attention to the pharmaceutical sector. Recent USFDA inspection outcomes highlight the industry’s ongoing focus on compliance and quality standards, while a major biosimilar licensing settlement clears the path for worldwide commercialisation. Together, these updates reflect both near-term regulatory challenges and long-term growth opportunities shaping investor sentiment.

Dr Reddy’s Laboratories

Dr Reddy’s Laboratories is a leading Indian pharmaceutical company with a strong presence in generics, APIs, and specialty medicines. It operates across key global markets including the US, Europe, and emerging economies. The company focuses on affordable healthcare, complex generics, and steady innovation-led growth.

With a market capitalization of Rs 1,05,913.81 crore, the shares were trading at Rs 1,269.05 per share, decreasing around 0.83 percent as compared to the previous closing price.

The USFDA has issued a Form 483 with five observations to Dr Reddy’s Laboratories following a GMP and pre-approval inspection at its Srikakulam formulations facility in Andhra Pradesh, conducted from December 4–12, 2025. While such observations signal compliance gaps, they are procedural and not uncommon. The company has stated it will respond and implement corrective actions within the prescribed timeline.

Aurobindo Pharma

Aurobindo Pharma is a major Indian drug manufacturer with strengths in generic formulations and active pharmaceutical ingredients. With a wide product portfolio and extensive global footprint, especially in the US and Europe, the company is known for cost-efficient manufacturing, backward integration, and scale-driven growth.

With a market capitalization of Rs 68,708.83 crore, the shares were trading at Rs 1,183.00 per share, decreasing around 0.90 percent as compared to the previous closing price.

The USFDA has issued a Form 483 with three observations to Aurobindo Pharma following an inspection of Unit-V, its API facility in Telangana, conducted from December 1–12, 2025. The company stated the observations are procedural and will be addressed within the stipulated timeframe. Aurobindo clarified that the inspection outcome does not affect ongoing operations at the facility.

Biocon

Biocon is a prominent biopharmaceutical company specialising in biologics, biosimilars, and research-led therapies. Through its subsidiary Biocon Biologics, the company has built a strong global presence in affordable biologics, targeting chronic and life-threatening diseases, while steadily expanding its footprint in regulated international markets.

With a market capitalisation of Rs 51,499.84 crore, the shares were trading at Rs 385.20 per share, decreasing around 0.38 percent as compared to the previous closing price.

Biocon said its arm Biocon Biologics has signed a global settlement and licence agreement with Regeneron and Bayer to commercialise Yesafili, a biosimilar Aflibercept, worldwide. The deal resolves all pending litigation and clears launches in the UK from January 2026 and other markets from March 2026, strengthening Biocon’s biosimilar growth prospects. Biocon is not about the USFDA observations.

Written by Abhishek Singh

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