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Natco Pharma Limited (NSE: NATCO Pharm) Receives FDA Approval for Eribulin Mesylate Injection

Natco Pharma Limited (NSE: NATCO PHARM) announces FDA approval for Eribulin Mesylate Injection, a bioequivalent to Halaven®.

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Natco Pharma Limited NSE NATCO PHARM FDA Approval Eribulin Mesylate Injection

Natco Pharma Limited (NSE: NATCO PHARM) announced today the approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, 1 mg/2ml (0.5 mg/ml) Single-Dose Vials. This marks a significant milestone for NATCO as it brings a bioequivalent version of the reference listed drug (RLD) Halaven® to the U.S. market. Eribulin Mesylate Injection is indicated for the treatment of adults with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease and unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

FDA Approval and Market Potential

The approval signifies a major step forward for NATCO in its oncology portfolio. Eribulin Mesylate Injection had estimated annual sales of USD 43.7 million in the U.S. (IQVIA MAT April 2026). This approval positions NATCO to tap into a lucrative market segment, offering an effective treatment option for patients in need.

Company’s Manufacturing and Regulatory Strength

Natco Pharma Limited, headquartered in Hyderabad, India, is a leading player in the development and manufacturing of generic and branded pharmaceuticals. The company’s nine manufacturing sites and two R&D facilities are approved by several leading regulatory authorities, including the U.S. FDA, Brazil ANVISA, Health Canada, and WHO, catering to over 50 global markets. This latest approval further underscores NATCO’s commitment to delivering high-quality, innovative pharmaceutical solutions worldwide.

For more information, please visit www.natcopharma.com. Rajeev Menon, Manager, Investor Relations, can be contacted at [email protected] or Tel: 040 -23547532 / Ext – 323.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Natco Pharma Limited

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

NATCOPHARM
Healthcare › Drug Manufacturers - Specialty & Generic
APPROACHING SUPPORT
80
Fundamental
50
Technical
66
Overall

1W -0.55%
1M -3.47%
3M -16.93%
P/E: 12.4 Cap: Mid
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Natco moves sideways over three months, with neither buyers nor sellers taking control. The PEG of 0.46 is extremely low. Either the market misses the growth story, or there is a catch worth investigating. Industry-leading margins of 34.8% reflect exceptional pricing power and operational efficiency. RSI stands at 28, well into oversold territory. Yet sellers still dominated on 13 of recent sessions versus 17 for buyers, so the pressure has not fully lifted. Revenue grows at 14.8% and profits at 25.6%. The business is in good shape. Moreover, a stock that does not move despite strong fundamentals often offers better value than one already priced for perfection. Check Fundamentals of Natco Pharma Limited.

ASTRAZEN

Astrazeneca Pharma India Limited (astrazen) Inaugurates New Mumbai Corporate Office, Marking Phase of Growth Through Innovation

AstraZeneca Pharma India Limited (NSE: ASTRAZEN) inaugurates new Mumbai office, signaling growth through innovation and commitment to advancing healthcare.

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Astrazeneca Pharma India Limited NSE Astrazen New Mumbai Office

AstraZeneca Pharma India Limited (NSE: ASTRAZEN) inaugurated its new corporate office in Mumbai, marking a significant step in its growth through innovation. The new office, spanning 25,600 sq ft, was inaugurated by Honorable Shri Devendra Fadnavis, Chief Minister of Maharashtra, alongside senior government officials and dignitaries.

Strategic Expansion

The new office signifies AstraZeneca’s ambition to transform care by unlocking the power of science. The company has introduced over 25 new medicines and indications in India in the past three years and is currently running about 80 global clinical trials in the country. This strategic move presents several opportunities for closer and effective partnerships with a vibrant healthcare ecosystem.

Commitment to Innovation

Arun Krishna, Non-Executive Director on the Board of AstraZeneca Pharma India Limited, emphasized India’s importance to AstraZeneca’s growth across Asia. The new commercial office in Mumbai will support closer engagement with stakeholders and the continued development of the company’s people. This step also supports AstraZeneca’s continued investment in talent and capability building in India, creating opportunities for professionals passionate about transforming healthcare.

As AstraZeneca expands, it will seek to attract and develop diverse talent across the value chain, reinforcing its broader purpose of advancing equitable healthcare globally. With this, India becomes one of the largest and diverse footprints of the organization around the world, supporting commercial operations, site management and monitoring, technology, research and development, and global business services.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of AstraZeneca Pharma India Limited

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

ASTRAZEN
Healthcare › Drug Manufacturers - Specialty & Generic
—
72
Fundamental
44
Technical
59
Overall

1W +2.29%
1M -10.93%
3M -25.59%
P/E: 88 Cap: Mid
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AstraZeneca drops 25.6% over three months and trades near its 52-week lows. The PEG reaches 3.73. The stock trades on brand and index weight, not on growth. Thin margins at 7.0% leave limited room for error — any demand softness or cost spike hits the bottom line hard. Sellers drive 1.6x the volume of buyers. Furthermore, they controlled 18 of recent sessions versus 12 for buyers — a clear distribution signal. The business compounds at 31.3% revenue and 23.6% profit CAGR, with D/E of 0.00. Yet the stock drops 25.6% in three months. The business does not deteriorate — the stock does. That gap is what long-term investors look for. Check Fundamentals of AstraZeneca Pharma India Limited.

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Healthcare

Solara Active Pharma Sciences Limited (solara) Q2’27: Revenue Surges 33% to INR 4,178 Mn, Ebitda More Than Doubles

Solara Active Pharma Sciences Limited (SOLARA) reports a 33% YoY revenue growth to INR 4,178 Mn and EBITDA more than doubling in Q2 FY27.

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Solara Active Pharma Sciences Limited Q2 FY27 Earnings Update

Solara Active Pharma Sciences Limited (SOLARA) has reported a stellar Q2 FY27 performance, with revenue surging 33% year-on-year to INR 4,178 Mn and EBITDA more than doubling to INR 769 Mn, marking its best quarter in five years. The company’s base business, excluding Ibuprofen, saw revenue grow 37% to INR 3,273 Mn and EBITDA jump 68% to INR 771 Mn. The Ibuprofen business, which was previously a loss-making segment, is now close to breakeven with revenue up 21% year-on-year and 18% quarter-on-quarter. The company’s overall profitability has improved significantly, with PAT turning positive at INR 285 Mn, compared to a loss of INR 101 Mn in the same period last year.

Base Business Performance

The base business continues to drive the overall growth, with revenue increasing 37% year-on-year to INR 3,273 Mn and EBITDA growing 68% to INR 771 Mn. The EBITDA margin expanded by 440 basis points year-on-year to 23.6%, reflecting improved business and operational efficiency.

Ibuprofen Business Turnaround

The Ibuprofen business has shown significant improvement, with revenue growing 21% year-on-year and 18% quarter-on-quarter. The EBITDA loss has narrowed to INR 2 Mn from INR 87 Mn in the previous quarter, indicating the business is now close to breakeven.

Overall Financial Health

Overall, Solara Active Pharma Sciences Limited has achieved its highest quarterly EBITDA and PAT in the last five years. Net debt has decreased by INR 1,141 Mn in H1 FY27 to INR 5,000 Mn, and the net debt to EBITDA ratio has improved to 1.8x from 3.2x at the end of FY26, strengthening the company’s balance sheet.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Solara Active Pharma Sciences Limited

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

SOLARA
Healthcare › Drug Manufacturers - Specialty & Generic
CONSOLIDATING DOWN
28
Fundamental
78
Technical
53
Overall

1W +8.12%
1M -2.08%
3M +22.06%
Cap: Small
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Solara posts a 13.7% three-month gain, but softens in the last few weeks. Razor-thin margins below 5% make profitability extremely vulnerable — this business needs scale or pricing power urgently. Revenue contracts at -1.2% CAGR. That signals structural headwinds, not a short-term blip. The stock gives back 9.4% in the last month despite a positive three-month run. As a result, the earlier momentum appears to be fading. The stock holds up despite -1.2% revenue growth and a PEG of 99.00. That could signal an early turnaround. Alternatively, index flows simply support the price. Watch whether analysts revise estimates upward — that is the real signal. Check Fundamentals of Solara Active Pharma Sciences Limited.

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Healthcare

Wanbury Limited (wanbury): Receives 9 ‘no DMF Deficiency’ Letters from Usfda, Expands Metformin Business Globally

Wanbury Limited (WANBURY) receives 9 ‘No DMF Deficiency’ letters from USFDA, expands Metformin business in Saudi Arabia and Mexico.

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Wanbury Limited Wanbury October 2026 Regulatory Updates

Wanbury Limited (WANBURY) has announced significant regulatory milestones and business expansions, reinforcing its position as a leading global supplier of Active Pharmaceutical Ingredients (APIs) and formulations. In July-August 2026, the company received 9 ‘No DMF Deficiency’ letters from the USFDA for its Metformin HCl Drug Master File (DMF), along with similar letters for Paroxetine and Diphenhydramine HCl APIs. These endorsements highlight the quality of Wanbury’s regulatory filings and open new business opportunities in the regulated US market.

Strengthening the API Pipeline

Wanbury is further expanding its API portfolio by validating new products, including Quetiapine Fumarate, Sitagliptin, and Empagliflozin. Regulatory filings for these products are planned for the next quarter, with the APIs expected to be available for sale in semi-regulated markets, adding to the company’s growth avenues.

Global Metformin Business Expansion

Wanbury has also made notable strides in its Metformin business. In Saudi Arabia, the company has commercialised a new Metformin DC (directly compressible) business, with an annual revenue potential of about Rs 10 crore. Additionally, a customer in Mexico has won a two-year tender for the supply of Metformin, valued at approximately Rs 15 crore per annum. These developments underscore Wanbury’s robust growth strategy in the Metformin sector.

Commenting on the developments, Mr. Mohan Rayana, Director of Wanbury Limited, said, “The ‘No DMF Deficiency’ letters from the USFDA are a strong endorsement of our quality and regulatory capabilities. With new Metformin business in Saudi Arabia and Mexico, and new APIs such as Quetiapine Fumarate, Sitagliptin, and Empagliflozin in our pipeline, we are well placed for sustained growth”.

Source: NSE Corporate Announcement

Fundamental & Technical Analysis of Wanbury Limited

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

WANBURY
Healthcare › Drug Manufacturers - Specialty & Generic
APPROACHING RESISTANCE
50
Fundamental
54
Technical
52
Overall

1W -2.07%
1M -13.58%
3M -42.1%
P/E: 11.8 Cap: Small
AI-Powered Analysis • TradeAlone
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Wanbury drops 43.9% over three months and trades near its 52-week lows. Thin margins at 8.6% leave limited room for error — any demand softness or cost spike hits the bottom line hard. Revenue consistency is the one bright spot — zero dips in five years shows operational resilience. RSI stands at 27, well into oversold territory. Yet sellers still dominated on 21 of recent sessions versus 9 for buyers, so the pressure has not fully lifted. Revenue grows at 8.9% 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 Wanbury Limited.

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