APLLTD - Alembic Pharma
📢 Recent Corporate Announcements
Alembic Pharmaceuticals Limited has successfully incorporated a new subsidiary, Alembic Pharmaceuticals (Thailand) Co., Ltd., in Thailand. The company holds a 99.99% stake in the new entity, which has an initial share capital of 3,000,000 Baht. This strategic move is designed to explore new business opportunities and facilitate the promotion, sale, and distribution of pharmaceutical products within the Thai geography. While the subsidiary has yet to commence operations, it marks a clear intent to strengthen the company's international presence.
- Incorporation of Alembic Pharmaceuticals (Thailand) Co., Ltd. as a 99.99% owned subsidiary
- Initial share capital of 3,000,000 Baht divided into 300,000 shares of 10 Baht each
- Primary objective is to promote and distribute pharmaceutical products in the Thailand market
- Current turnover is nil as the entity is newly incorporated and yet to start operations
- Investment is made in cash for the acquisition of share capital
Alembic Pharmaceuticals has achieved its first prescription sale of Pivya® in the US, marking its official entry into the US branded specialty market. Pivya® is a first-line antibiotic for uncomplicated urinary tract infections (uUTIs), a therapeutic category with approximately 30 million prescriptions annually in the US. This launch follows a strategic acquisition and represents a shift from a purely generic-focused model to a branded specialty portfolio in the US. The company has established an initial sales footprint and plans a phased expansion of its field force to drive growth.
- First prescription sale of Pivya® in the US, marking Alembic's first branded product launch in the region.
- Targets the uUTI market in the US, which accounts for approximately 30 million prescriptions annually.
- Marketed through Alembic Therapeutics LLC, a step-down wholly owned subsidiary of the company.
- Represents a strategic shift to build a branded specialty portfolio alongside its established generics business.
- Initial sales footprint established across key US territories with plans for phased field force expansion.
Alembic Pharmaceuticals has issued a postal ballot notice to seek shareholder approval for the appointment of Mr. Rajkumar Baheti as a Non-Executive Non-Independent Director effective April 1, 2026. The company is also seeking a special resolution to pay him professional fees up to ₹2.50 Crores per annum for one year, which is in addition to standard sitting fees. This fee exceeds the typical monetary thresholds prescribed under the Companies Act, requiring specific member approval. The e-voting period for these resolutions is scheduled from March 2 to March 31, 2026.
- Proposed appointment of Mr. Rajkumar Baheti as Non-Executive Non-Independent Director starting April 1, 2026
- Approval sought for professional fees up to ₹2.50 Crores per annum plus applicable taxes
- The professional fee arrangement is proposed for a period of one year
- Remote e-voting period set from March 2, 2026, to March 31, 2026
- The professional fee resolution is a Special Resolution, requiring 75% majority for approval
Alembic Pharmaceuticals has received final USFDA approval for Lamotrigine Orally Disintegrating Tablets in 25 mg, 50 mg, 100 mg, and 200 mg strengths. The product is a generic version of GSK's Lamictal ODT and is used to treat seizures and bipolar I disorder. The addressable market for this product is estimated at US$ 27 million for the 12 months ending December 2025. This approval brings Alembic's total USFDA ANDA approvals to 235, including 216 final approvals.
- Received final USFDA approval for Lamotrigine Orally Disintegrating Tablets USP in four strengths.
- Estimated market size for the product is US$ 27 million for the 12 months ending December 2025.
- Product is therapeutically equivalent to GlaxoSmithKline's Lamictal ODT.
- Cumulative USFDA ANDA approvals now stand at 235, with 216 final and 19 tentative approvals.
Alembic Pharmaceuticals has concluded an unannounced USFDA inspection at its Karakhadi Injectable Facility (F-3). The inspection, which took place from February 9 to February 18, 2026, resulted in two observations. Crucially, the company stated that none of the observations are related to data integrity, which is often a major concern for regulators. The company intends to respond to these observations within the required timeframe to maintain its compliance status.
- USFDA conducted an unannounced cGMP inspection at the Karakhadi (F-3) injectable facility.
- The inspection spanned 10 days from February 9th to February 18th, 2026.
- The audit concluded with 2 observations, none of which pertain to data integrity.
- The company will submit a formal response to the observations within the stipulated time.
Alembic Pharmaceuticals reported a steady Q3 FY26 with revenue growing 11% YoY to ₹1,876 crores, driven by a robust 36% growth in Rest of World (ROW) markets and 6% growth in the US. EBITDA (pre-R&D) increased 20% to ₹464 crores, reflecting improved operating leverage despite gross margins moderating to 72% due to pricing pressures. A significant strategic milestone is the upcoming Q4 launch of 'Pivya,' the company's first branded product in the US market. While domestic growth remained tepid at 6%, management expects to return to market growth rates by Q1 FY27.
- Revenue grew 11% YoY to ₹1,876 crores, with EBITDA (pre-R&D) rising 20% to ₹464 crores.
- US business grew 6% YoY with 7 new ANDA approvals and a strategic branded launch (Pivya) planned for Q4 FY26.
- ROW markets delivered strong performance with 36% YoY growth, offsetting pricing pressures in API and US generics.
- R&D spend increased 33% to ₹165 crores (9% of revenue) to support complex injectables and peptides.
- One-time exceptional provision of ₹42 crores recognized due to New Labour Code employee benefit changes.
Alembic Pharmaceuticals has received final USFDA approval for its ANDA for Carbidopa, Levodopa, and Entacapone Tablets in six different strengths. These tablets are indicated for the treatment of Parkinson's disease and are therapeutically equivalent to the reference drug Stalevo. This approval marks a significant addition to the company's US portfolio, which now includes a cumulative total of 234 ANDA approvals. The company continues to leverage its vertically integrated R&D to expand its global generic footprint.
- Received final USFDA approval for Carbidopa, Levodopa, and Entacapone Tablets in 6 dosage strengths.
- The product is a generic version of Orion Corporation's Stalevo Tablets used for Parkinson's disease.
- Alembic now has a cumulative total of 234 ANDA approvals, consisting of 214 final and 20 tentative approvals.
- The company maintains a strong domestic presence with a field force of over 5,500 personnel.
Alembic Pharmaceuticals has officially shared the audio recording link for its post-results conference call conducted on February 5, 2026. This disclosure follows the announcement of the company's financial results for the period. The recording provides investors with direct access to management's responses to analyst queries and their outlook on the pharmaceutical sector. Accessing such recordings is vital for understanding the nuances of the company's operational strategy and margin guidance.
- Audio recording of the conference call held on February 5, 2026, is now available for public review.
- The filing follows the company's prior intimation regarding the analyst meet dated January 21, 2026.
- The recording is hosted on the official website under the 'Quarterly Results' section for transparency.
Alembic Pharmaceuticals reported a 10.8% YoY growth in consolidated revenue to ₹1,876.31 crore for Q3 FY26. Net profit after non-controlling interests saw a slight decline of 3.9% YoY to ₹132.97 crore, primarily due to a one-time exceptional charge of ₹42.23 crore related to the implementation of new Labour Codes. Despite the profit dip, operating margins remained resilient at 16.42%, up from 16.00% in the previous year. The company also announced that Mr. Rajkumar Baheti will transition to a Non-Executive Director role effective April 2026.
- Consolidated Revenue from Operations increased 10.8% YoY to ₹1,876.31 crore.
- Net Profit (PAT) stood at ₹132.97 crore, impacted by a ₹42.23 crore exceptional provision for employee benefits.
- Operating Margin improved to 16.42% in Q3 FY26 compared to 16.00% in Q3 FY25.
- Debt-Equity ratio remains stable and healthy at 0.25x.
- Mr. Rajkumar Baheti appointed as Non-Executive Director effective April 1, 2026, following his tenure as Executive Director.
Alembic Pharmaceuticals reported a steady Q3 FY26 with revenue growing 11% YoY to INR 18.76 billion, driven largely by a 36% surge in Ex-US Generics. While EBITDA grew 14% to INR 3.08 billion, the bottom line was impacted by a one-time exceptional loss of INR 0.42 billion, leading to a slight 4% dip in PAT to INR 1.33 billion. The India Branded and US Generics segments showed moderate growth of 6% each, while the Animal Health division performed strongly with 22% growth. R&D investments remained significant at 9% of revenue, supporting a pipeline of 270 ANDA filings.
- Total Revenue increased 11% YoY to INR 18.76 billion in Q3 FY26.
- Ex-US Generics revenue reached an all-time high of INR 4.06 billion, growing 36% YoY.
- EBITDA margins stood at 16%, with EBITDA growing 14% YoY to INR 3.08 billion.
- India Branded Business grew 6% to INR 6.52 billion, maintaining a 21st rank in the Indian Pharmaceutical Market.
- R&D expenditure increased to INR 1.65 billion, representing 9% of total revenue.
Alembic Pharmaceuticals reported a steady 11% YoY revenue growth for Q3 FY26, reaching ₹1,876 Cr, driven by a robust 36% surge in Ex-US international generics. EBITDA grew 14% to ₹308 Cr with margins at 16%, although reported PAT of ₹133 Cr was impacted by a one-time ₹42 Cr provision for labor code changes. The company maintained high R&D investment at 9% of revenue and is preparing for the launch of PivyaTM in the US market during Q4. Core segments like India Branded and US Generics showed modest growth of 6% each.
- Revenue from operations increased 11% YoY to ₹1,876 Cr with EBITDA rising 14% to ₹308 Cr.
- Ex-US International Generics business outperformed with 36% growth, reaching ₹406 Cr.
- Reported PAT stood at ₹133 Cr after accounting for a ₹42 Cr one-time provision for employee benefits.
- R&D expenditure remains significant at 9% of revenue to support a pipeline of 232 cumulative ANDA approvals.
- India Branded Business grew 6% to ₹652 Cr, supported by Gynaecology and Ophthalmology segments.
Alembic Pharmaceuticals reported a steady Q3 FY26 with total international generic sales growing 17% YoY to ₹954 crore, driven by strong performance in Australia (65%) and Canada (32%). The US market saw a modest 6% growth to ₹553 crore, supported by new launches like Sacubitril Valsartan. Domestic branded formulations grew 6% YoY to ₹652 crore, with the Animal Health segment showing robust growth of 22%. The company continues its R&D momentum with 5 ANDA filings YTD and 7 launches planned for Q4 FY26.
- International Generics revenue grew 17% YoY to ₹954 Cr, with Australia and EROW segments leading growth at 65% and 36% respectively.
- US Direct sales reached ₹478 Cr, a 7% YoY increase, aided by new product launches like Ticagrelor and Metoprolol.
- Domestic Branded Formulations grew 6% YoY to ₹652 Cr, significantly bolstered by a 22% surge in the Animal Health business.
- API business remained relatively flat with 2% YoY growth, totaling ₹263 Cr for the quarter.
- Strong R&D pipeline with 212 cumulative final ANDA approvals and 7 new products planned for launch in Q4 FY26.
Alembic Pharmaceuticals reported a steady 10.8% year-on-year growth in consolidated revenue to ₹1,876.31 crore for the quarter ended December 31, 2025. Reported net profit for the quarter stood at ₹132.97 crore, a slight decline from ₹138.42 crore in the previous year, primarily due to a one-time exceptional charge of ₹42.23 crore related to new Labour Code provisions. Excluding this exceptional item, the Profit Before Tax (PBT) showed robust growth of 14.6% YoY, reaching ₹203.73 crore. The company also announced the transition of Mr. Rajkumar Baheti to a Non-Executive Director role effective April 2026.
- Consolidated Revenue from Operations increased 10.8% YoY to ₹1,876.31 crore.
- Profit Before Tax (before exceptional items) grew 14.6% YoY to ₹203.73 crore.
- Net Profit after tax stood at ₹132.97 crore, impacted by a ₹42.23 crore one-time provision for labour code compliance.
- Operating Margin (EBITDA before exceptional items) was reported at 16.42% for the quarter.
- Debt-to-Equity ratio remains stable and healthy at 0.25x as of December 31, 2025.
Alembic Pharmaceuticals reported a 10.8% YoY growth in consolidated revenue for Q3 FY26, reaching ₹1,876.31 crore. However, Net Profit for the quarter declined slightly to ₹132.97 crore from ₹138.42 crore in the previous year, primarily due to a one-time exceptional charge of ₹42.23 crore related to the new Labour Code provisions. On a nine-month basis, the company performed better with revenue growing 12% to ₹5,497.18 crore. The board also approved the appointment of Mr. Rajkumar Baheti as a Non-Executive Director effective April 2026.
- Consolidated Revenue from Operations increased 10.8% YoY to ₹1,876.31 crore.
- Net Profit after non-controlling interests stood at ₹132.97 crore, down 3.9% YoY due to exceptional items.
- A one-time exceptional expense of ₹42.23 crore was recognized for gratuity and wage revisions under new Labour Codes.
- Operating Margin (EBITDA before exceptional items) for the quarter was 16.42%.
- Debt-Equity ratio remains healthy at 0.25x with a Net Worth of ₹5,463.32 crore.
Alembic Pharmaceuticals Limited has informed the exchanges regarding the superannuation of Mr. Ashok Pandya from the position of Resident Director. The retirement is effective from the close of business hours on January 31, 2026. This change in Senior Management Personnel is a routine administrative event following the completion of his tenure. The company has complied with Regulation 30 of SEBI (LODR) Regulations for this disclosure.
- Mr. Ashok Pandya has retired from the position of Resident Director at Alembic Pharmaceuticals.
- The cessation of service is effective from January 31, 2026, after business hours.
- The reason for the change is cited as superannuation (retirement).
- The filing was made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
Financial Performance
Revenue Growth by Segment
Consolidated revenue grew 7% YoY to INR 6,672 Cr in FY25. For H1 FY26, revenue increased 13% YoY to INR 3,621 Cr. The India Branded Business grew 5% YoY in Q2 FY26 to INR 639 Cr. International generic business showed healthy growth, while the API business experienced a decline in FY25 but is expected to recover.
Geographic Revenue Split
The company has a significant presence in the US market, which is expected to grow by at least 10% per annum over FY26-FY27. Other key markets include Canada, Chile, the European Union, and Australia, with strategic alliances strengthened in Australia and Europe through new product launches.
Profitability Margins
Gross margins are guided to remain in the 70-75% range. The PAT margin stood at 9% in FY25. Operating margins are expected to improve to 16-17% over the medium term as capacity utilization of new facilities increases.
EBITDA Margin
EBITDA margin improved to 16% in FY25 from 15% in FY24, representing a 10% growth in absolute EBITDA to INR 1,053 Cr. H1 FY26 EBITDA margin (post-R&D) was 17% (INR 613 Cr), reflecting improved capacity utilization and revenue growth.
Capital Expenditure
The company has completed its major capital expenditure cycle for three new manufacturing facilities. Annual cash accruals of INR 700-800 Cr are expected to be sufficient to cover routine maintenance capex and working capital requirements.
Credit Rating & Borrowing
Credit ratings are maintained with a 'Stable' outlook. Total debt increased to INR 1,258 Cr as of March 31, 2025, from INR 513 Cr in the previous year due to higher working capital needs. Interest costs for Q2 FY26 rose to INR 76 Cr from INR 71 Cr YoY.
Operational Drivers
Raw Materials
Active Pharmaceutical Ingredients (APIs) and specialty chemicals used in complex chemistry formulations; specific chemical names not disclosed.
Capacity Expansion
The company has three new manufacturing facilities targeted at the US market, all of which are USFDA approved. Commercial operations began in H2 FY23 and FY24. Current focus is on ramping up utilization to achieve economies of scale.
Raw Material Costs
Raw material costs are managed through a focus on high-margin projects and cost optimization measures to maintain gross margins above 70%.
Manufacturing Efficiency
Capacity utilization is currently sub-optimal at new facilities, resulting in an overhead absorption impact of approximately INR 150 Cr in FY25, which constrained profitability.
Strategic Growth
Expected Growth Rate
10-11%
Growth Strategy
Growth will be driven by ramping up three new USFDA-approved facilities, launching 15-20 new products in the US market in FY26, and focusing on complex chemistry and specialty therapies like Entresto and Pivya. The company is shifting its portfolio mix toward higher-margin specialty products to enhance profitability.
Products & Services
Differentiated generics, specialty therapies, branded formulations, and Active Pharmaceutical Ingredients (APIs).
Brand Portfolio
Alembic Pharmaceuticals.
New Products/Services
Planned launch of 15-20 products in the US market in FY26. Recent launches include Pivya and Entresto generics.
Market Expansion
Expanding geographic presence in the US, Canada, Chile, EU, and Australia.
Strategic Alliances
Strategic alliances with partners in Australia and Europe for new product launches; acquisition of Utility Therapeutics to support the Pivya launch.
External Factors
Industry Trends
The industry is seeing growing penetration of health insurance and a shift toward complex generics. Alembic is positioning itself by investing in R&D for difficult-to-formulate molecules that generate superior value.
Competitive Landscape
Intense competition in the US generic space and domestic acute therapy segments.
Competitive Moat
Moat is built on a strong ANDA pipeline (220 cumulative approvals), USFDA-approved manufacturing infrastructure, and expertise in complex chemistry. These are sustainable due to high entry barriers in specialty generics.
Macro Economic Sensitivity
Margins are sensitive to inflation-driven costs and pricing pressure in international markets.
Consumer Behavior
Increased demand for specialty therapies and chronic disease treatments.
Geopolitical Risks
Exposure to regulatory changes in India and overseas markets (US, EU, Australia).
Regulatory & Governance
Industry Regulations
Subject to USFDA, European Medicines Agency (EMA), and TGA Australia inspections. Domestic operations are impacted by the Drug Pricing Control Order (DPCO).
Environmental Compliance
Not disclosed in absolute INR; company maintains ESG compliance to facilitate capital raising.
Taxation Policy Impact
Tax expense for H1 FY26 was INR 0.76 Bn.
Legal Contingencies
No major instances of litigations or product recalls reported in the past.
Risk Analysis
Key Uncertainties
US price erosion, USFDA regulatory risks, and the speed of sales ramp-up from new facilities (overhead cost of INR 150 Cr).
Geographic Concentration Risk
Relatively high exposure to the US generic business, which is currently facing pricing pressure.
Technology Obsolescence Risk
Mitigated by R&D focus on complex molecules and high-value platforms.
Credit & Counterparty Risk
Trade receivables stood at INR 1,314 Cr as of September 30, 2025; collection cycles have extended in certain export markets.