Alkem Laboratories , a leading Indian pharmaceutical company, has reported robust financial results for the second quarter and first half of fiscal year 2026, demonstrating significant growth across key metrics.

Financial Highlights

Half-Year Results (H1 FY26)

• Revenue: Alkem's revenue from operations increased to ₹27,144.90 million from ₹24,816.90 million in the same period last year.
• Net Profit: Consolidated net profit rose to ₹2,394.00 million, compared to ₹2,063.20 million in H1 FY25, marking a 16% increase.
• Earnings Per Share (EPS): Basic EPS for the six months was ₹119.55, up from ₹103.20 in the previous year.

Q2 FY26 Results

• Revenue: Revenue from operations surged by 17.2% year-over-year (YoY) to ₹40,010.00 million, up from ₹34,147.00 million in Q2 FY25.
• EBITDA: Earnings before Interest, Tax, Depreciation, and Amortisation (EBITDA) grew by 22.3% YoY to ₹9,208.00 million, with the EBITDA margin improving to 23.0% from 22.0%.
• Net Profit: Net profit for the quarter increased to ₹1,279.80 million, compared to ₹1,152.00 million in the previous year quarter.
• EPS: EPS for the quarter stood at ₹64.00, up from ₹57.60 in Q2 FY25.

Segment Performance

Domestic Business

• Domestic revenue grew by 12.4% YoY to ₹27,660.00 million, contributing 69.9% to total sales.
• Alkem became the number one company in the Indian Pharmaceutical Market (IPM) for the Acute segment during the quarter.
• The company outperformed the IPM in six key therapy areas, including Anti-infectives, Gastrointestinal, VMN, Pain, Respiratory, and Derma segments.

International Business

• International sales showed strong growth, increasing by 29.5% YoY to ₹11,890.00 million.
• US sales grew by 28.0% YoY to ₹7,649.00 million, contributing 19.3% to total sales.
• Non-US international sales rose by 32.4% YoY to ₹4,241.00 million, driven by robust growth in Australia and key European markets.

Operational Highlights

• During Q2 FY26, Alkem filed 2 ANDAs, received 1 ANDA tentative approval, and launched 4 products in the US market.
• As of September 30, 2025, the company had filed 187 ANDAs, 2 NDAs, and 1 BLA with the USFDA, receiving approvals for 163 ANDAs (including 17 tentative approvals) and 2 NDAs.
• R&D expenses for the quarter were ₹1,302.00 million, representing 3.3% of total revenue from operations.
• The company's total assets stood at ₹174,260.80 million as of September 30, 2025.
• Exceptional items for the half-year included a gain of ₹142.90 million from the sale of Indore facility.
• Alkem executed a Business Transfer Agreement effective October 1, 2025, transferring its Generic Business Undertaking to wholly-owned subsidiary Alkem Wellness Limited.

Management Commentary

Dr. Vikas Gupta, CEO of Alkem, commented on the results: "Q2 FY26 has been another strong quarter for us, marked by robust growth across India, the US, and key international markets. We also saw healthy traction in new product launches across markets. The GST revision is a positive step, and we adapted swiftly to ensure a seamless transition. Our improved gross margins and operating leverage have contributed to a stronger EBITDA profile. As we look ahead, we remain focused on accelerating growth and continue to strengthen our presence in key markets."

Alkem Laboratories' strong performance in Q2 and H1 FY26 reflects its solid positioning in both domestic and international markets. The company's focus on key therapeutic areas and expansion in international markets, particularly the US, continues to drive its growth. With a robust pipeline of ANDAs and strategic initiatives in place, Alkem appears well-positioned for sustained growth in the coming quarters.

Alkem Laboratories has announced the successful completion of a European Union Good Manufacturing Practice (EU GMP) inspection at its manufacturing facility in Baddi, India. The inspection, conducted by the German Health Authority, concluded without any major issues being identified, marking a significant milestone for the company's quality assurance efforts.

Inspection Details

The EU GMP inspection, a critical regulatory requirement for pharmaceutical companies exporting to the European Union, took place over a week-long period. Here are the key details of the inspection:

Implications for Alkem Labs

The successful completion of the EU GMP inspection without any major observations is a positive development for Alkem Laboratories. This outcome:

1. Validates the company's compliance with EU quality standards
2. Potentially strengthens Alkem's position in the European pharmaceutical market
3. Demonstrates the company's commitment to maintaining high-quality manufacturing processes

Company Statement

In a regulatory filing, Manish Narang, President - Legal, Company Secretary and Compliance Officer of Alkem Laboratories, stated, "The said inspection was concluded today with no critical or major observations."

Conclusion

The successful EU GMP inspection at Alkem's Baddi facility underscores the company's adherence to international quality standards. This development may bolster investor confidence and potentially support Alkem's growth strategies in the European market. However, as with all regulatory inspections, ongoing compliance and continuous improvement remain crucial for sustained success in the pharmaceutical industry.