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Lupin Limited Receives Tentative Approval from U.S. FDA for Enzalutamide Tablets

Lupin Limited (LUPIN) secures tentative approval from U.S. FDA for Enzalutamide Tablets, expanding dosage options.

Deputy Editor, Equities for tradealone

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Lupin Limited LUPIN FDA Approval Enzalutamide June 2026

Lupin Limited (LUPIN) announced today that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Enzalutamide Tablets, 40 mg, 80 mg, 120 mg, and 160 mg. The U.S. FDA has tentatively approved Lupin’s Enzalutamide Tablets, 40 mg and 80 mg as bioequivalent to reference listed drug (RLD) Xtandi® Tablets of Astellas for the approved indication. Notably, Lupin’s tentatively approved 120 mg and 160 mg strengths will provide healthcare providers and patients with alternative dosing options.

FDA Approval Milestone

This approval marks a significant milestone for Lupin, reinforcing its position in the global pharmaceutical market. The company has been dedicated to delivering high-quality, cost-effective medications to patients worldwide. The FDA’s tentative approval of Lupin’s Enzalutamide Tablets is a testament to the company’s robust manufacturing and quality control processes.

Expanding Dosing Options

The inclusion of 120 mg and 160 mg strengths in the tentative approval is particularly noteworthy. Traditionally, Xtandi Tablets are available in 40 mg and 80 mg strengths. However, Lupin’s new dosages will offer more flexibility and potentially improve treatment outcomes for patients. This move is expected to enhance the company’s market presence and patient access to essential medications.

As a global pharmaceutical leader, Lupin continues to focus on improving patient health outcomes through its comprehensive range of pharmaceutical products. With 15 state-of-the-art manufacturing sites and 7 research centers globally, Lupin is well-positioned to meet the growing demand for high-quality, affordable medications.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Lupin Limited

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

LUPIN
Healthcare › Drug Manufacturers - Specialty & Generic
APPROACHING RESISTANCE
84
Fundamental
48
Technical
66
Overall

1W +0.26%
1M -4.08%
3M -19.71%
P/E: 16.2 Cap: Large
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Lupin holds in the upper half of its 52-week range, a sign the market backs the stock. The PEG of 0.15 is extremely low. Either the market misses the growth story, or there is a catch worth investigating. The business compounds revenue at 19.1% and profits at 131.5% CAGR. That is strong double-digit growth on both counts. The stock trades at 77% of its 52-week range — near its best levels of the year. Clearly, the market pays a premium for this name. Both the business and the stock move in the right direction. Revenue grows at 19.1%, profits at 131.5%, and the PEG sits at 0.15 — below its growth rate. That combination is rare. Check Fundamentals of Lupin Limited.

Healthcare

Morepen Laboratories Limited Launches Desloratadine Tablets in U.S. Prescription Market

Morepen Laboratories Limited (MOREPENLAB) launches Desloratadine Tablets in U.S. prescription market, expanding its pharmaceutical capabilities.

Pranab Tyagi at TradeAlone

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Morepen Laboratories Limited Morepenlab U.S. Prescription Market Launch

Morepen Laboratories Limited (MOREPENLAB) announced the launch of its first prescription (Rx) generic product, Desloratadine Tablets USP, 5 mg, in 100-count and 500-count packs for distribution in the U.S. market. This initiative is being undertaken through its wholly owned U.S. arm, Morepen Bio Inc. Building on its established API position, this move extends the company’s participation further along the pharmaceutical value chain into finished-dosage medicines and U.S. distribution.

Strategic Expansion into Prescription Market

Sanjay Suri, Managing Director of Morepen Laboratories Limited, said, “Our long-standing API relationships in regulated markets provide a strong foundation for Morepen’s next phase of growth. Alongside our expanding CDMO business, we are selectively extending our capabilities into finished-dosage development and U.S. distribution. This reflects our strategy to build a more integrated, R&D-led pharmaceutical business with sustainable, long-term growth opportunities.”

Regulatory Milestones

The prescription generics expansion follows Morepen’s earlier U.S. OTC product introductions. Separately, the company has submitted its first Abbreviated New Drug Application (ANDA) to the U.S. FDA for Sitagliptin Phosphate Tablets USP, 25 mg, 50 mg, and 100 mg. This milestone demonstrates Morepen’s growing capabilities in formulation development, analytical science, and regulatory filings. The application is currently under regulatory review.

Looking ahead, Morepen intends to pursue additional U.S. prescription generic filings and distribution opportunities where its established API and pharmaceutical R&D capabilities provide a competitive advantage. The company may also evaluate selected opportunities in high-potency APIs (HPAPIs) and oncology, subject to development feasibility, regulatory requirements, and market conditions.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Morepen Laboratories Limited

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

MOREPENLAB
Healthcare › Drug Manufacturers - Specialty & Generic
CONSOLIDATING DOWN
60
Fundamental
84
Technical
72
Overall

1W -4.38%
1M +7.97%
3M +110.31%
P/E: 48.4 Cap: Mid
AI-Powered Analysis • TradeAlone
Download the App for in-depth analysis of this stock

Morepen gains 110.3% over three months and trades near its 52-week highs. Thin margins at 7.2% leave limited room for error — any demand softness or cost spike hits the bottom line hard. The PEG of 1.39 sits close to fair value. The stock is neither a clear buy nor obviously expensive. Buyers show up with 1.7x the volume of sellers. Moreover, they dominated on 16 of recent sessions versus 14 for sellers — a healthy accumulation pattern. The stock rises 110.3% in three months on 8.4% 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 Morepen Laboratories Limited.

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COHANCE

Cohance Lifesciences Limited Investor Presentation Q2 FY27: Sequential Recovery Gaining Traction

Cohance Lifesciences Limited (COHANCE) Q2 FY27 investor presentation highlights sequential recovery, revenue up 13% QoQ.

priyanka verma tradealone

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Cohance Lifesciences Limited Cohance Q2 FY27 Investor Presentation

Cohance Lifesciences Limited (COHANCE) showcased a clear sequential recovery in its Q2 FY27 investor presentation, with revenue up 13% QoQ and adjusted EBITDA margin improving to 10% from 2% in Q1. The integrated capabilities of One Cohance are strengthening the growth platform.

Strategic Progress

The integration of One Cohance is driving operational and commercial progress across businesses. In the Pharma CDMO segment, the order and reload position for Q3 and Q4 has improved materially. Cohance secured two new commercial and one late-stage programme with large global pharma customers, strengthening relationships and medium-term growth opportunities. In the nucleic acid business, Sapala’s strong performance is supported by increasing integration of its specialised chemistry and customer relationships with Cohance’s development and manufacturing network.

Financial Performance

API+ revenue grew year-on-year, supported by selective pricing actions, while lower API volumes, shipment phasing, and higher raw-material costs impacted margins. Specialty Chemicals declined YoY due to lower AgChem volumes, pricing pressure, and programme phasing, while Performance Materials remained relatively stable. The company plans to announce investments in capex towards building capabilities in adjacencies and R&D to unlock the full potential of the One Cohance platform.

Looking Ahead

H2 FY27 revenue and EBITDA are expected to grow year-on-year, supported by continued recovery and progressive integration of Cohance’s capabilities to unlock platform potential. The H2 focus is on improving revenue mix and utilisation to support progressive margin recovery.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Cohance Lifesciences Limited

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

COHANCE
Healthcare › Drug Manufacturers - Specialty & Generic
—
50
Fundamental
74
Technical
62
Overall

1W +5.23%
1M +7.18%
3M +5.01%
P/E: 170 Cap: Mid
AI-Powered Analysis • TradeAlone
Download the App for in-depth analysis of this stock

Cohance moves sideways over three months, with neither buyers nor sellers taking control. Thin margins at 5.0% leave limited room for error — any demand softness or cost spike hits the bottom line hard. 1 loss quarter(s) over five years signals earnings fragility — not chronic but worth noting. The stock holds at 30% of its 52-week range with RSI at 58. In other words, neither side has a clear edge right now. The stock rises 5.0% in three months on 18.3% 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 Cohance Lifesciences Limited.

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FERMENTA

Fermenta Biotech Limited (fermenta) Q2 FY27: Revenue Up 8%, Ebitda Rises 3%

Fermenta Biotech Limited (FERMENTA) reports Q2 FY27 results with revenue up 8% QoQ to INR 135.8 crore and EBITDA up 3% QoQ.

Shruti singh - TradeAlone

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Fermenta Biotech Limited Fermenta Q2 FY27 Results

Fermenta Biotech Limited (FERMENTA) announced its financial results for Q2 FY27, showing a robust performance in the quarter. The company reported a revenue of INR 135.8 crore, up 8% from the previous quarter, and EBITDA increased by 3% QoQ to INR 23.2 crore.

Financial Highlights

The consolidated revenue for Q2 FY27 stood at INR 135.8 crore, a marginal increase of 0.1% year-on-year but an 8% rise quarter-over-quarter. The EBITDA for the quarter was INR 23.2 crore, showing a 3% QoQ growth. Profit after tax (PAT) for the quarter was INR 9.4 crore, down 48% YoY but down 1% QoQ.

Sector Performance

Human Nutrition, the primary revenue source, grew by 2% in H1 FY27 to INR 162.5 crore, contributing significantly to the overall revenue. India’s contribution to the half-year revenue rose to 51%, up from 40% a year earlier, reflecting the company’s expanding market presence.

Operational Milestones

Fermenta Biotech Limited achieved several milestones during the quarter, including the FSSAI approval for VITADEE Green® in July, the NSE listing in August, and securing an exclusive license for VIT Vellore Vitamin B12 in September. Looking ahead, the company expects to ramp up VITADEE Green® capacity from Q2 FY28 and aims to complete regulatory approvals for Calcifediol by the end of FY27.

Despite the challenges in the animal nutrition segment, Fermenta Biotech Limited continues to leverage its strengths in human nutrition and diversified markets to drive growth and maintain a low customer concentration, with the largest customer accounting for only 9% of revenue.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Fermenta Biotech Limited

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

FERMENTA
Healthcare › Drug Manufacturers - Specialty & Generic
APPROACHING SUPPORT
56
Fundamental
62
Technical
59
Overall

1W -6.1%
1M +3.4%
3M +12.33%
P/E: 24.1 Cap: Small
AI-Powered Analysis • TradeAlone
Download the App for in-depth analysis of this stock

Fermenta rises 12.3% over three months, with buying pressure holding steady. Revenue grows at 14.5% CAGR. The company generates cash but does not compound aggressively. The stock holds at 38% of its 52-week range with RSI at 43. In other words, neither side has a clear edge right now. Revenue grows at 14.5% and the stock moves sideways over three months. Neither side makes a strong case. The next earnings print will likely break this stock out of its current range. Check Fundamentals of Fermenta Biotech Limited.

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