Alembic Ltd. Share Price

ALEMBIC PHARMA: RECEIVES USFDA FINAL APPROVAL FOR VENETOCLAX

ALEMBIC PHARMA: RECEIVES USFDA FINAL APPROVAL FOR VENETOCLAX TABLETS

• USFDA granted final approval for ANDA for Venetoclax Tablets in 10 mg, 50 mg and 100 mg strengths • Product is therapeutically equivalent to Venclexta Tablets of AbbVie Inc. • Alembic was the first ANDA applicant with Paragraph IV certification and may be eligible for 180 days of generic drug exclusivity • Product is indicated for adult CLL/SLL patients and, in combination, for newly diagnosed AML in adults aged 75 years or older or those with comorbidities • IQVIA estimates the US market size at approximately US$1.58 billion for the 12 months ended June 2026 • Cumulative USFDA approvals for Alembic now stand at 248 ANDAs, comprising 228 final and 20 tentative approvals Impact: Positive — First-to-file Paragraph IV status with potential 180-day exclusivity provides a strong opportunity to capture a meaningful share of a large US generic market. However, the actual revenue benefit will depend on the exclusivity outcome, launch timing, pricing and competitive intensity.

See More

Alembic Pharma Gets USFDA Nod for Valganciclovir

Alembic Pharmaceuticals received final USFDA approval for its ANDA for Valganciclovir for Oral Solution, 50 mg/mL, therapeutically equivalent to Valcyte (CHEPLAPHARM). The drug treats CMV retinitis in AIDS patients and prevents CMV disease in high-risk kidney, heart or kidney-pancreas transplant patients. The approval takes Alembic’s total to 247 ANDAs: 227 final and 20 tentative. Disclaimer: Investments in securities market are subject to market risks. Read all related documents carefully before investing. Registration granted by SEBI and certification from NISM in no way guarantee the performance of the intermediary or provide any assurance of returns to investors. The above information is for educational and learning purpose. They analyst or his associates do not hold any shares of the company and have no financial interest in it. SEBI Registered Research Analyst: Vineet Ashwinikumar Chawla: INH000008190, BSE Enlistment No: 5433

See More

Alembic Pharma Receives USFDA Approval for Ear Drops

Alembic Pharmaceuticals Ltd has received final approval from the US Food and Drug Administration (USFDA) for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%. The approval expands the company’s US generic drug portfolio and creates an opportunity to strengthen its presence in the US market. Key Details - Company: Alembic Pharmaceuticals Ltd - Approval: USFDA final approval - Product: Ciprofloxacin and Dexamethasone Otic Suspension USP - Strength: 0.3% / 0.1% - Dosage Form: Ear-drop suspension - Therapeutic Use: Used to treat certain bacterial ear infections accompanied by inflammation. - Business Impact: Potential to contribute to US generics revenue, subject to commercial launch, competition and market demand. Fundamental Ratios - Revenue: Refer to the latest quarterly results. - Operating Margin: Check the latest reported quarter. - ROE / ROCE: Refer to the latest annual or TTM figures. - Debt-to-Equity: Review the latest balance sheet. Risk Factors - Strong competition from other generic drug manufacturers. - Pricing pressure in the US pharmaceutical market. - Sales depend on launch timing, distribution and market share. - Manufacturing quality and regulatory compliance requirements. - The approval alone does not guarantee a significant revenue contribution. Market Takeaway The USFDA approval is a positive regulatory development for Alembic Pharmaceuticals, expanding its approved product portfolio. Investors may monitor the commercial launch, competitive intensity and potential contribution to US business growth. Disclaimer: This post is for educational and informational purposes only and should not be considered investment advice or a recommendation to buy or sell any security. Investors should conduct their own research or consult a SEBI-registered investment professional before making investment decisions.

See More

Alembic Pharma gets USFDA Approval for Otic Suspension

Alembic Pharmaceuticals Limited

has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3%/0.1%. This regulatory approval represents a positive development for the company’s US generics business and further strengthens its portfolio of approved pharmaceutical products in the world’s largest pharmaceutical market. The approved formulation is a combination of ciprofloxacin, a fluoroquinolone antibiotic, and dexamethasone, a corticosteroid. It is used to treat certain bacterial ear infections, including acute otitis media in pediatric patients with tympanostomy tubes and acute otitis externa in eligible patients. The combination helps eliminate susceptible bacteria while reducing inflammation, swelling and discomfort associated with these infections. The final USFDA approval enables Alembic to commercially market the generic formulation in the United States, subject to applicable regulatory and commercial requirements. The development highlights the company’s capabilities in developing and obtaining approvals for specialized generic formulations, including otic products. From a business perspective, the approval is expected to strengthen Alembic’s US product portfolio, create an additional revenue opportunity and support its long-term growth strategy in international markets. However, the actual financial contribution will depend on the timing of commercialization, market competition, pricing dynamics and the company’s ability to capture market share. Overall, the approval is a positive regulatory milestone for Alembic Pharmaceuticals, reinforcing its presence in the US generics market. Investors will closely monitor the product’s commercial launch, potential market opportunity and contribution to future revenue and profitability.

See More

✅ Alembic Pharma Secures USFDA Nod for New Ear Drops

Alembic Pharmaceuticals Ltd has received final approval from the US Food and Drug Administration (USFDA) for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%. This milestone enhances Alembic’s US generics portfolio and opens avenues to strengthen its foothold in the competitive US pharmaceutical market. 📌 Key Highlights: - Product: Ciprofloxacin and Dexamethasone Otic Suspension (ear drops) - Strength: 0.3% / 0.1% - Indication: Treats bacterial ear infections and related inflammation under medical prescription - Approval: Final USFDA clearance secured 📈 Business Implications: - Potential to boost Alembic’s US generics revenue, subject to launch timing and market reception - Competitive landscape and pricing pressures remain key challenges - Regulatory compliance and manufacturing quality will be critical for sustained success 🔍 Market Insight: While the approval marks a significant regulatory win, the actual impact on Alembic’s financials will depend on sales volumes, market share, and competition from established generic players in the US. 🚦 Investors should watch for product launch updates and evolving market dynamics to gauge growth potential. Disclaimer: This post is for educational and informational purposes only and should not be considered investment advice or a recommendation to buy or sell any security. Investors should conduct their own research or consult a SEBI-registered investment professional before making investment decisions.

See More

Alembic Limited: Promoter Group Buys Shares

Limited (ALEMBICLTD) witnessed a notable promoter group transaction with Nirayu Private Limited purchasing shares through a market purchase during 28 September to 29 September 2026. According to the disclosed transaction details Nirayu Private Limited acquired 74 554 shares of Alembic Limited at an average price of ₹106.96 per share. The total value of the transaction stood at approximately ₹79.75 lakh. Following the purchase the promoter group holding increased from 63.55% to 63.58%. This represents an increase of 0.03 percentage points in the disclosed holding. Promoter group transactions are closely watched by market participants because changes in promoter ownership can provide additional information about shareholder activity. A promoter group purchase may indicate an increase in ownership exposure. However investors should not interpret a single transaction as a standalone signal for the future direction of the stock. For Alembic Limited investors can track further promoter group transactions along with shareholding disclosures and the company's financial and operational developments. Monitoring whether additional purchases take place can provide greater context around the change in promoter ownership. The transaction was disclosed on 30 September 2026 and involved a market purchase by Nirayu Private Limited. Disclosure: This content is for informational purposes only and should not be construed as investment advice or a recommendation to buy or sell any security. Investors should conduct their own research and consider their individual risk profile and financial circumstances before making investment decisions.

See More