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GRANULES

Granules India Limited (granules) Gains Potential First-to-file Status on Ruxolitinib Extended-release Tablets ANDA

Granules India Limited (GRANULES) announced potential first-to-file status for its Ruxolitinib Extended-Release Tablets ANDA, aiming for 180 days of generic.

Reena Bhati - Tradealone

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Granules India Limited Granules First-to-file Status ANDA

Granules India Limited (GRANULES) announced that it has submitted a Paragraph IV certification in connection with its ANDA for Ruxolitinib Extended-Release Tablets with respect to applicable patents listed in the U.S. Food and Drug Administration’s (FDA) Orange Book. This move positions the company for potential first-to-file status for Ruxolitinib Extended-Release Tablets, which may grant 180 days of generic drug exclusivity under U.S. law.

Strategic Filing

The ANDA remains subject to FDA review, and this announcement should not be construed as FDA approval of the product or confirmation by the FDA of first-to-file status or exclusivity. This strategic filing reflects Granules India Limited’s focus on identifying technically and commercially attractive opportunities where its development and manufacturing capabilities can create sustainable value.

Company Outlook

Commenting on the development, Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India Limited, said: “First-to-file opportunities are an important part of our strategy to build a more differentiated and higher-value product portfolio in the U.S. This filing reflects our focus on identifying technically and commercially attractive opportunities where our development and manufacturing capabilities can create sustainable value. We look forward to progressing the product through the regulatory process.”

The company will provide further updates, as appropriate, in accordance with applicable disclosure requirements. This communication contains forward-looking statements relating to, among other things, the Company’s ANDA, potential first-to-file status, possible eligibility for 180-day exclusivity, regulatory review, and commercialization prospects. Such statements are subject to risks and uncertainties, including those relating to FDA actions, patent litigation, exclusivity determinations, competition, and other factors, and actual outcomes may differ materially from those expressed or implied herein.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Granules India Limited

Granules India Limited belongs to the › sector. Here’s a quick read on where the business and the stock stand today.

GRANULES
Healthcare › Drug Manufacturers - Specialty & Generic
—
50
Fundamental
82
Technical
67
Overall

1W -3.5%
1M -1.4%
3M -2.69%
P/E: 31.1 Cap: Large
AI-Powered Analysis • TradeAlone
Download the App for in-depth analysis of this stock

Granules holds in the upper half of its 52-week range, a sign the market backs the stock. The PEG stands at 6.48 — severely stretched. Any earnings miss could trigger a sharp de-rating. No meaningful dividend — total return is entirely dependent on capital appreciation. The stock trades at 78% of its 52-week range — near its best levels of the year. Clearly, the market pays a premium for this name. The stock rises -2.7% in three months on 5.9% revenue growth. As a result, the market gives it more credit than the fundamentals strictly justify. Watch the next quarterly results. If growth accelerates, the move makes sense. If not, expect some gains to unwind. Check Fundamentals of Granules India Limited.

Drug Manufacturers - Specialty and Generic

Granules India Limited (GRANULES) shows pressure after breakout, falls 5% intraday

Granules India Limited (GRANULES) stock is down 5% intraday at ₹829.1, showing retracement post-breakout gains.

shalini shishodia tradealone

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Granules India Limited GRANULES retraces post-breakout gains

Granules India Limited (GRANULES) fell -5% to ₹829.1 on the NSE on 22 Jul 2026, backed by its Q1 FY27 results where revenue surged 22% YoY and PAT jumped 60%. The stock’s decline today can be attributed to the shift in trendline status from CONSOLIDATING UP to APPROACHING RESISTANCE, with the stock now just 1.0% away from the resistance level at ₹837. This move is also notable as the stock is currently 10% above its 50-DMA, indicating a stretched position. In the healthcare sector, specifically within drug manufacturers, Granules India’s performance reflects strong financial results but also highlights the stock’s sensitivity to technical levels and market sentiment.

Technical setup — trendlines & DMA

From a technical perspective, Granules India’s current price is navigating a critical juncture. The 6M support trendline is established at ₹762.53, which is 8.03% below today’s price, providing a solid floor. Conversely, the resistance trendline ends at ₹837.06, just 0.96% above the current price, indicating imminent resistance. The 50-DMA at ₹795.2 is below the current price, suggesting a bullish trend as the stock is trading 10.12% above this average. Additionally, the stock is significantly above the 200-DMA at ₹645.1, up 35.75%, reinforcing the bullish sentiment. Within the 52W range of ₹432.6 to ₹910.0, the current price sits in the upper third, reflecting a strong upward move but also indicating that a substantial portion of the potential gain might already be priced in.

6M Trendline — Intraday Snapshot
APPROACHING RESISTANCE₹700₹800₹9009 Apr14 May18 Jun22 Jul

Snapshot: ₹829.10 on 2026-07-22 (chart frozen at publication)

Fundamentals & business context

On the fundamental front, Granules India’s PE of 35.8, coupled with an 11.1% profit margin and a revenue CAGR of 5.9%, suggests that the stock is trading at a premium relative to its earnings growth. This valuation might reflect market expectations of future growth, possibly driven by the company’s robust Q1 FY27 performance. The institutional holding of 21.0% indicates a moderate level of confidence from smart money, though not overwhelmingly bullish. There is no specific NSE catalyst today beyond the earnings release, which already significantly impacted the stock’s movement.

GRANULES
Holdings Analysis
Key strengths & risk signals
67
Overall
51
Fundamental
83
Technical
Risks (3)
OVERVALUED! PEG of 6.48 means expensive relative to growth rate.
RECOVERY MODE! Current price (836.4) above 200-day but below 50-day.
NEGATIVE MOMENTUM! Price declined across timeframes - down 3.5% (1 week), 1.4% (1 month), 2.7% (3 months).
Strengths (4)
MODERATE STABILITY! 2 revenue dips in history. Acceptable but monitor closely.
BULLISH TREND! 50-day average (854.5) is above 200-day average (722.0) - positive signal.
GOOD YEAR! Stock gained 47.8% in the last year.
BULLISH SENTIMENT! In last 30 days: 14 up days, 16 down days. Avg volume on up days: 1,570,688 vs down days: 920,248. Ratio: 1.71x

Algorithmic scorecard

The algorithmic scorecard for Granules India reflects a technically strong but fundamentally weaker profile. The stock’s technical strength is underscored by its bullish trend, with the 50-day average above the 200-day average, and its breakout status, indicating strong momentum. The stock’s low volatility, as evidenced by a beta of 0.10, also suggests a stable investment with less market risk. However, the fundamental weaknesses are notable, particularly the overvalued PEG of 7.46, which indicates the stock may be expensive relative to its growth rate. Additionally, the negligible dividend yield of 0.2% offers little income for investors, potentially limiting its appeal to income-focused investors.

Fundamental & Technical AnalysisNSE: GRANULES
67Overall
51Fundamental
83Technical
Growth Quality13 / 30
Revenue CAGR: 5.9% (MODERATE, 8/15). Profit CAGR: 4.8% (SLOW, 5/15).
Profit Margin5 / 10
DECENT EFFICIENCY! 11.8% profit margin - acceptable profitability.
PEG Valuation0 / 10
OVERVALUED! PEG of 6.48 means expensive relative to growth rate.
Dividend Yield3 / 10
NEGLIGIBLE DIVIDEND! 0.21% yield - little to no income.
Debt / Equity10 / 10
VERY LOW DEBT! D/E of 0.00 - excellent financial health.
Public Holding14 / 20
MODERATE PUBLIC HOLDING! 29.95% public ownership - balanced ownership structure.
Stability6 / 10
MODERATE STABILITY! 2 revenue dips in history. Acceptable but monitor closely.
Moving Averages12 / 10
BULLISH TREND! 50-day average (854.5) is above 200-day average (722.0) - positive signal.
Price Position2 / 10
RECOVERY MODE! Current price (836.4) above 200-day but below 50-day.
Trend Pattern16 / 20
TESTING SUPPORT! Stock is at key support level.
52W Performance10 / 10
GOOD YEAR! Stock gained 47.8% in the last year.
Volume Sentiment30 / 30
BULLISH SENTIMENT! In last 30 days: 14 up days, 16 down days. Avg volume on up days: 1,570,688 vs down days: 920,248. Ratio: 1.71x
RSI3 / 5
NEUTRAL! RSI at 45.6 - balanced momentum.
52W Range4 / 5
UPPER HALF! Trading at 77.9% of 52W range - positive territory.
Momentum1 / 5
NEGATIVE MOMENTUM! Price declined across timeframes - down 3.5% (1 week), 1.4% (1 month), 2.7% (3 months).
Beta / Volatility5 / 5
LOW VOLATILITY! Beta of 0.10 - stable stock, less market risk.

Company outlook

Granules India’s management has outlined several strategic initiatives and outlooks for the coming fiscal year. The company anticipates potential U.S. product launches as approvals progress, with 9 applications awaiting clearance from the Gagillapur site. They aim to maintain a working capital to sales ratio in the 33% range despite cost escalations. For the peptide CDMO business, Granules India expects EBITDA and PAT positivity from FY ’27 onwards. In terms of capital expenditure, the company plans a broad-based approach for FY ’27, including a new API facility, IT investments, and a distribution center in the U.S.A., with a planned capex in the range of INR 600-odd crores, including INR 200 crores plus for the distribution center. Additionally, there are investments planned for a brownfield manufacturing facility for peptide intermediates in India, followed by a peptide API capacity.

Get all details on GRANULES — P&L, peers, shareholding and more on TradeAlone.

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GRANULES

Granules India Limited (granules) Q1 FY27: Revenue Up 22% Yoy, PAT Surges 60%

Granules India Limited (GRANULES) reports Q1 FY27 results with revenue up 22% YoY, EBITDA up 37%, and PAT up 60%.

Pranab Tyagi at TradeAlone

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Granules India Limited Granules Q1 FY27 Results

Granules India Limited (GRANULES) today announced its financial results for the quarter ended June 30, 2026. The company reported a revenue from operations of INR 14,768 Mn, marking a 22% year-on-year growth. The EBITDA stood at INR 3,389 Mn, up 37% YoY, while the PBT before exceptional item was INR 2,404 Mn, up 41% YoY. The PAT reached INR 1,800 Mn, showing a 60% increase compared to the same quarter last year.

Financial Summary

The financial summary for Q1 FY27 highlights a robust performance across key metrics. The revenue from operations grew by 22% YoY, EBITDA increased by 37% YoY, PBT before exceptional items rose by 41% YoY, and PAT surged by 60% YoY. Despite a 4% QoQ decline in EBITDA, the company’s strong performance in PAT reflects its strategic focus on operational excellence and growth.

Market and Operational Insights

The company’s revenue share from North America decreased slightly to 72% in Q1 FY27 from 77% in Q1 FY26, while the share from Europe increased to 16% from 13%. Finished dosages, Active Pharmaceutical Ingredients (API), Pharmaceutical Formulation Intermediates (PFI), and Peptides CDMO contributed 74%, 13%, 9%, and 4% of revenue respectively. The Return on Capital Employed (ROCE) improved to 18.0% in Q1 FY27 from 17.6% in FY26. Net debt reduced to INR 1,012 Mn, a significant decrease from INR 9,479 Mn in Q1 FY26.

Forward-Looking Statement

Commenting on the results, Dr. Krishna Prasad Chigurupati, Chairman & Managing Director of Granules India Limited, said, “Q1 FY27 marks an important step forward for Granules India as the foundations strengthened during FY26 begin to translate into greater execution confidence, strategic clarity, and business resilience. Our focus remains firmly on regulatory and quality excellence, portfolio transformation toward complex and differentiated products, geographic and customer diversification, and scaling new growth engines. While external cost pressures and supply chain volatility require continuous management for the next couple of quarters, we are continuing to invest in R&D largely towards Complex Gx, digitalization, operational excellence, sustainability, and talent to support long-term value creation. With a stronger organization, a more balanced portfolio, and clear strategic priorities, we remain confident in Granules’ ability to deliver sustainable growth for all stakeholders.”

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Granules India Limited

Granules India Limited belongs to the › sector. Here’s a quick read on where the business and the stock stand today.

GRANULES
Healthcare › Drug Manufacturers - Specialty & Generic
—
50
Fundamental
82
Technical
67
Overall

1W -3.5%
1M -1.4%
3M -2.69%
P/E: 31.1 Cap: Large
AI-Powered Analysis • TradeAlone
Download the App for in-depth analysis of this stock

Granules gains 31.2% over three months and trades near its 52-week highs. The PEG stands at 7.46 — severely stretched. Any earnings miss could trigger a sharp de-rating. No meaningful dividend — total return is entirely dependent on capital appreciation. The stock trades at 93% of its 52-week range — near its best levels of the year. Clearly, the market pays a premium for this name. The stock rises 31.2% in three months. Yet revenue grows at only 5.9% and the PEG stands at 7.46. Either the market prices in a turnaround that has not shown up yet, or this is momentum without substance. Check the next two earnings prints before drawing conclusions. Check Fundamentals of Granules India Limited.

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GRANULES

Granules India Limited (granules) Secures Sole First-to-file ANDA Status for Sodium Oxybate Extended-release for Oral Suspension

Granules India Limited (GRANULES) secures Sole First-to-File status for its ANDA for Sodium Oxybate Extended-Release for Oral Suspension.

adit chauhan author tradealone

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Granules India Limited Granules Sole First-to-file ANDA Status

Granules India Limited (GRANULES) has announced securing Sole First-to-File (FTF) status for its Abbreviated New Drug Application (ANDA) for Sodium Oxybate Extended-Release for Oral Suspension, the generic equivalent of LUMRYZ® extended-release oral suspension. This marks Granules’ second Sole First-to-File ANDA, following its earlier success with Amphetamine Extended-Release Tablets, the generic equivalent of Dyanavel XR®. This achievement further demonstrates the company’s growing capabilities in developing and advancing complex, differentiated generic products for the U.S market.

Milestone in Complex Generics Journey

“Securing Sole First-to-File status for our Sodium Oxybate Extended Release for Oral Suspension ANDA is another important milestone in our complex generics journey. This achievement reflects the strength of our R&D and regulatory capabilities, while reinforcing our commitment to building a differentiated portfolio. We remain focused on expanding patient access to affordable treatment options and delivering sustainable long-term growth.” — Dr. Krishna Prasad Chigurupati, Chairman & Managing Director, Granules India Limited

Strengthens Position in Complex Generics Segment

The Sole First-to-File designation further strengthens Granules’ position in the complex generics segment and underscores the Company’s continued focus on innovation, execution excellence, and strategic portfolio expansion in regulated markets. LUMRYZ® (sodium oxybate) extended-release oral suspension is indicated in the United States for the treatment of cataplexy or excessive daytime sleepiness in patients with narcolepsy.

Granules India Limited, incorporated in 1991, is a vertically integrated, fast-growing Indian pharmaceutical company headquartered in Hyderabad, with best-in-class facilities and a commitment to operational excellence, quality, and customer service. The company has a global presence extending to over 80 countries and offices across India, the US, and Switzerland.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Granules India Limited

Granules India Limited belongs to the › sector. Here’s a quick read on where the business and the stock stand today.

GRANULES
Healthcare › Drug Manufacturers - Specialty & Generic
—
50
Fundamental
82
Technical
67
Overall

1W -3.5%
1M -1.4%
3M -2.69%
P/E: 31.1 Cap: Large
AI-Powered Analysis • TradeAlone
Download the App for in-depth analysis of this stock

Granules gains 35.9% over three months and trades near its 52-week highs. The PEG stands at 7.10 — severely stretched. Any earnings miss could trigger a sharp de-rating. No meaningful dividend — total return is entirely dependent on capital appreciation. The stock trades at 98% of its 52-week range — near its best levels of the year. Clearly, the market pays a premium for this name. The stock rises 35.9% in three months. Yet revenue grows at only 5.9% and the PEG stands at 7.10. Either the market prices in a turnaround that has not shown up yet, or this is momentum without substance. Check the next two earnings prints before drawing conclusions. Check Fundamentals of Granules India Limited.

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