Granules India Share Price in Focus After USFDA Flags 1 Observation — What Investors Should Know
On June 23, 2025, Granules India share price drew market attention following an official update that the company’s API Unit-I facility in Hyderabad received one observation from the USFDA after a routine inspection. The inspection was conducted between June 16 and June 20, 2025, at Bonthapally Village, Sangareddy District, Telangana.
Granules India Limited has assured that it will respond to the USFDA's observation within the stipulated time. This development has sparked curiosity among investors, especially considering the importance of the Hyderabad facility, which is among the world’s largest single-site Paracetamol API manufacturing plants.
🔍 What Does It Mean When USFDA Gives “1 Observation”?
When the USFDA (United States Food and Drug Administration) visits a pharmaceutical company’s facility — like the one Granules India has in Hyderabad — they check if everything is being done properly, safely, and as per international standards.
At the end of the inspection, if they find something that isn’t up to the mark, they note it down as an “observation” in a document called Form 483. It’s not a fine, and the plant doesn’t get shut down. It’s more like a warning or suggestion saying, “This area needs improvement.”
In the case of Granules India, the USFDA made just one observation. This could be related to anything like record keeping, cleanliness, safety processes, or how medicines are being handled.
The company now needs to look into it, fix the issue, and respond to the USFDA within the given time. This is a common part of pharma inspections — it doesn’t mean something is seriously wrong, but it’s something that needs to be addressed quickly and properly.
In simple words: The USFDA told the company, “Hey, there’s one thing you should fix.” And now, it’s up to Granules India to take the right steps and close it.
📉 Stock Performance
The granules india share price has seen significant volatility over the past year:
- ✅ 52-week High: ₹724.55 (on September 2, 2024)
- ❌ 52-week Low: ₹412.05 (on April 7, 2025)
- 📌 Current Price: ₹487.25 (approx., down 32.81% from 52-week high)
- 📈 Still 18.15% above its 52-week low
As of now, the company’s market capitalization stands at a robust ₹11,813.11 crore, reflecting investor faith despite occasional regulatory hurdles.
🏭 What Does Granules India Do?
Granules India Ltd is a Hyderabad-based pharmaceutical company known for manufacturing and exporting Active Pharma Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages. The company exports to over 80 countries and serves over 300 global clients.
Its product portfolio includes widely used drugs such as paracetamol, metformin, guaifenesin, and methocarbamol. The company’s revenues are heavily driven by its Finished Dosages segment, which contributed 64% of revenue in FY24, showing a clear shift from raw ingredient sales to value-added products.
🌐 Global Footprint and Market Reach
- North America: 66% of revenue (FY24)
- Europe: 19%
- India: 5%
- LATAM + RoW: 10%
The company also holds a leadership position in the CNS/ADHD drug space in the US, with 7 of its products ranked number one in their respective categories. Additionally, two of its OTC products have market leadership status.
🏗️ Facilities & Future Expansion
Granules India currently operates 7 manufacturing facilities — 6 in India and 1 in the USA. It is setting up a new finished dosage unit in Genome Valley, Hyderabad, through its wholly owned subsidiary, Granules Life Sciences (GLS). The Phase 1 capacity of 2.5 billion dosages will go live by Q4 FY25.
In FY24, the company spent nearly ₹100 crore in capex and has outlined ₹600 crore in planned investment for FY25, showing its ambition to expand both capacity and capabilities. It also boasts significant API, PFI, and dosage manufacturing capacity:
- API: ~39,400 TPA
- PFI: ~24,600 TPA
- Finished Dosages: ~30 billion units
🔬 R&D and Product Pipeline
Granules India has been ramping up innovation. In FY24 alone, the company spent 4.4% of its revenue (~₹120 crore) on research and development. It filed 20 ANDA/Dossiers — 12 of them in the US. It also operates four R&D centers across India, focused on oncology, anti-diabetics, and expanding into nasal sprays and liquid formulations.
💻 Cybersecurity Challenge and Recovery
The company faced a major ransomware attack in May 2023, which disrupted its operations and led to delays in product releases. However, it successfully recovered and continued strengthening its IT systems post-incident.
🔍 Conclusion: Should You Watch Granules India Share?
The granules india limited share price is expected to remain volatile in the short term due to the USFDA observation. However, the long-term outlook appears promising. With strong global presence, a diverse product portfolio, market leadership in several categories, and aggressive expansion plans, Granules India Ltd is well-positioned for future growth.
Investors should monitor the company’s response to the USFDA’s feedback and watch how quickly it resolves the observation. If managed well, it may offer a decent opportunity for long-term investors.
Disclaimer: This blog is for informational purposes only and not a recommendation to buy or sell shares. Please consult a financial advisor before making investment decisions.
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