Granules India Share Price Falls After USFDA Issues Observation to Hyderabad Facility

Market Performance

Granules India's share price experienced a dip in early trading on June 23, 2025, following a regulatory update regarding its facility in Hyderabad.

• Current Price: ₹483.45
• Change: Down by ₹3.40 or 0.70% on the BSE
• Market Cap: ₹11,730.61 Crore
• 52-week High: ₹724.55 (as of September 2, 2024)
• 52-week Low: ₹412.05 (as of April 7, 2025)
• The stock is currently 33.28% below its 52-week high.
• It remains 17.33% above its 52-week low.

Main Update

Granules India's stock came under pressure after the US Food and Drug Administration concluded an inspection at one of its key manufacturing facilities.

• The API Unit-I facility, located at Bonthapally Village, Hyderabad, underwent a US FDA inspection from June 16 to June 20, 2025.
• The inspection resulted in the issuance of a single Form 483 observation.
• The company confirmed that it would address and respond to the observation within the required timeline.

Company Details

The Bonthapally facility is a significant asset in Granules India's manufacturing network:

• Recognized as one of the world's largest single-site Paracetamol API manufacturing plants by volume.
• The site also houses facilities for producing Metformin and Guaifenesin APIs.

This facility plays a crucial role in Granules India's bulk drug manufacturing and export operations.

Summary

Granules India's share price declined by 0.70% following the announcement of a single USFDA observation at its Hyderabad-based Bonthapally unit. Despite this, the company maintains a solid operational base with a strategically significant API manufacturing plant. Investors are closely watching regulatory developments while the stock continues to trade between its annual high and low levels.