Alkem Labs Secures EU GMP Certificate for Daman Facility

Introduction

Alkem Laboratories Ltd. has secured a key regulatory approval for its manufacturing facility in Daman, receiving a Certificate of Good Manufacturing Practices (GMP) Compliance from the Malta Medicines Authority. This certification, which aligns with European Union standards, strengthens the company's position in the European market. The announcement comes as Alkem also moves forward with significant domestic expansion, earmarking up to ₹533 crore for a new greenfield facility in Ujjain, Madhya Pradesh.

Daman Facility Receives EU GMP Nod

The pharmaceutical major announced on March 20, 2026, that its Daman plant has been certified as compliant with EU GMP standards. The certificate was issued following an inspection conducted by the Malta Medicines Authority from December 5 to December 9, 2025. According to the company's disclosure, the inspection concluded with no critical observations, though it noted three major and a few minor observations. Alkem has committed to addressing these findings within the stipulated timeframe. The certificate is valid for three years from the inspection date, providing a stable pathway for the company to supply products manufactured at this site to the European Union.

Strategic Expansion with New Ujjain Plant

In a move signaling strong domestic growth ambitions, Alkem Laboratories also confirmed it has received an allotment letter for approximately 30 acres of land in Ujjain. The land, located in Phase 2 of the industrial area developed by DMIC Vikram Udyogpuri Ltd., will house a new greenfield formulations manufacturing facility. The company's board has approved a phased investment of up to ₹533 crore for this project. This expansion is set to enhance Alkem's manufacturing capacity and support its long-term growth strategy within India.

Baddi Facility Also Gains EU Approval

Reinforcing its commitment to global quality standards, Alkem recently received another EU GMP certification for its manufacturing facility in Baddi, India. This certificate was granted by the German Department of Pharmacy following an inspection that took place from November 4 to November 10, 2025. Notably, the inspection of the Baddi plant concluded with no critical or major observations, highlighting the robustness of the facility's quality management systems. This dual certification for two separate facilities underscores the company's manufacturing prowess and regulatory diligence.

Financial Performance in Q3 FY25

Alkem Laboratories demonstrated steady financial performance in the quarter ending December 2025. The company reported a 5% year-on-year increase in net profit, which stood at ₹626 crore compared to ₹595 crore in the same period last year. Revenue from operations saw a marginal rise of 1.5% to ₹3,374 crore.

A key highlight was the improvement in operational efficiency. Earnings before interest, tax, depreciation, and amortisation (EBITDA) climbed 7.4% to ₹759 crore. The EBITDA margin expanded by 120 basis points to 22.5%, surpassing the company's full-year guidance of 18.5-19%.

International Market Contribution

The company's global footprint remains a significant contributor to its revenue. In the December quarter, sales from the United States accounted for 19.1% of the total sales. During this period, Alkem received two approvals from the US Food and Drug Administration (USFDA), including one tentative approval. Other international markets, primarily in Latin America, Australia, and Europe, contributed 9.8% to the total sales, a segment poised to grow following the recent EU GMP certifications.

Market Reaction

The series of positive developments was reflected in the company's stock performance. Shares of Alkem Laboratories Ltd. closed at ₹5,284.50 on the BSE on March 20, marking an increase of ₹43.70, or 0.83%, for the day. The regulatory approvals and expansion plans appear to have been received favorably by investors, reinforcing confidence in the company's operational and strategic direction.

Conclusion

Alkem Laboratories has started the year on a strong note with crucial EU GMP certifications for both its Daman and Baddi facilities, significantly enhancing its access to the lucrative European market. Coupled with a substantial investment in a new manufacturing plant in Ujjain and stable financial results, the company is well-positioned for both international and domestic growth. Investors will be watching how these strategic initiatives translate into increased export revenues and market share in the upcoming quarters.