Concord Biotech Limited has announced the successful completion of a European Union Good Manufacturing Practice (EU GMP) inspection at its Active Pharmaceutical Ingredient (API) facility in Limbassi. This marks a significant milestone for the company as it seeks to expand its global footprint and enhance its regulatory compliance.

Inspection Details

The EU GMP authorities conducted their first inspection of Concord Biotech's API manufacturing facility in Limbassi from August 18 to August 21, 2025. The company reported that the inspection process has been concluded at this manufacturing site.

Significance of EU GMP Inspection

The completion of the EU GMP inspection is a crucial step for Concord Biotech, as it:

• Validates the company's commitment to global quality standards
• Opens doors for expanding into new international markets
• Enables exploration of commercial opportunities across various EU territories and other regulated geographies
• Strengthens the company's global presence and growth trajectory

Company's Perspective

In an official statement, Concord Biotech emphasized that this milestone reaffirms their commitment to maintaining the highest standards of quality, safety, and regulatory compliance. The company views this as a reflection of their dedication to operational excellence and alignment with global regulatory expectations.

About Concord Biotech

Concord Biotech Limited is a pharmaceutical company headquartered in Ahmedabad, Gujarat. The company specializes in the development and manufacturing of Active Pharmaceutical Ingredients (APIs). With its state-of-the-art facility in Limbassi, Concord Biotech continues to strengthen its position in the global pharmaceutical market.

The successful completion of the EU GMP inspection is expected to bolster Concord Biotech's reputation and potentially lead to new business opportunities in the European Union and other regulated markets. As the pharmaceutical industry continues to evolve, such regulatory milestones play a crucial role in determining a company's competitiveness and market access on the global stage.

Concord Biotech Limited , a leading biopharmaceutical company, has reported its financial results for the first quarter, revealing a moderate performance impacted by customer procurement patterns and commercialization costs of its new injectable facility.

Key Financial Highlights

Segment Performance

Operational Highlights

• Received US FDA approval for teriflunomide tablets
• Successfully passed inspections by US FDA, European GMP, and Russian GMP authorities
• Incorporated two new subsidiaries: Stellon Biotech Inc. for US market operations and Concord Lifegen Limited for domestic marketing
• Initiated CDMO business sales to the US market
• Launched two products from the injectable facility in the domestic market

Management Commentary

Sudhir Vaid, Chairman and Managing Director, commented on the results: "We reported a stable performance this quarter with revenues at INR 204 crores, impacted mainly by revenue lumpiness. The preceding quarter had exceptionally high sales and historically, such strong quarters are followed by relatively softer ones."

Ankur Vaid, Joint Managing Director and CEO, added: "Our EBITDA and PAT registered a decline primarily due to the commencement of our injectable facilities at Valthera. These initial costs are expected to weigh on EBITDA margins until revenue from the facility scales up gradually."

Future Outlook

The company remains optimistic about its long-term growth prospects, citing several growth drivers:

1. Market growth in existing products
2. Conversion of innovator businesses to generic
3. New customer acquisition as a second-source supplier
4. New product launches and market penetration

Concord Biotech is also focusing on expanding its CDMO business, targeting potential revenues of $40-50 million in the coming years.

The management expects the injectable facility costs to normalize as revenues scale up, with a potential break-even by the end of FY26. The company continues to invest in R&D and expand its product portfolio to maintain its competitive edge in the fermentation-based API market.

Despite the short-term challenges, Concord Biotech remains confident in its ability to deliver strong growth, leveraging its expertise in complex niche products and expanding its presence in both domestic and international markets.