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Pharma stock falls 7% after USFDA issues warning letter to its facility in Gagillapur

Prominent pharma company received a USFDA Warning Letter for its facility after an inspection. While existing operations continue, corrective actions are underway to ensure compliance and sustain growth across key global markets.
Pharma stock drops 7% as USFDA issues warning letter to its Gagillapur facility.
Pharma stock drops 7% as USFDA issues warning letter to its Gagillapur facility.

Introduction:

Leading Pharma company has received a Warning Letter from the USFDA for its manufacturing facility following an inspection. While existing operations remain unaffected, the company is implementing corrective actions to ensure compliance and sustain its growth across key global markets.

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Also Read: Stock jumps 6% after reporting 33.1% YoY increase in net profits

Shrae price movement of Granules India:

On February 28, 2025, Granules India Ltd. opened at ₹488.05, down 3.74% from its previous close of ₹507.70. The stock reached a high of ₹493.45 and a low of ₹466.85. By 12:06 PM, it traded at ₹467.00, with a market cap of ₹11,324.46 crore.

Granules India Receives USFDA Warning Letter for Gagillapur Facility:

Granules India Ltd. announced that the USFDA issued a Warning Letter to its Gagillapur facility on February 26, 2025, following an August 2024 inspection. While the letter may impact pending product reviews, existing manufacturing and distribution remain unaffected.

The company has implemented a rigorous remediation plan, engaging independent consultants to oversee compliance improvements. Granules voluntarily paused manufacturing in September 2024 for risk assessment and has since resumed operations.

Despite regulatory challenges, Granules remains optimistic about resolving the issue within a reasonable timeframe. The company continues expanding through its GPI facility in the US, European markets, and new ventures in oncology, ensuring business growth beyond the Gagillapur site’s regulatory concerns.

Recent news on Granules India:

As of February 21, 2025, Granules India Ltd. announced the acquisition of Swiss-based CDMO Senn Chemicals AG, strengthening its presence in peptide-based therapeutics, including GLP-1 receptor agonists. The deal is expected to close in the first half of 2025.

Stock performance of Granules India for Period of 1 week, 6 months and 1 year:

Granules India Ltd. saw a marginal 0.31% decline over the past week, while its six-month performance dropped by 29.4%. However, the stock posted a strong 9.02% gain over the past year, reflecting long-term resilience despite recent volatility.

Also Read: Stock jumps 3.5% after receiving order worth ₹325 Cr from South Eastern Railway

Shareholding pattern of Granules India:

ParticularsDec 2024Sep 2024Jun 2024
Promoter38.90%38.90%38.90%
FII15.90%19.50%20.40%
DII19.60%14.90%14.10%
Public26%26.80%26.60%
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About Granules India:

Granules India Ltd. (NSE: GRANULES) is engaged in manufacturing and selling Active Pharma Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages. The company focuses on delivering high-quality pharmaceutical solutions across global markets with strong R&D capabilities.

Disclaimer: The above article is written for educational purposes, and the companies’ data mentioned in the article may change with respect to time The securities quoted are exemplary and are not recommendatory.

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