Concord Biotech has announced the successful completion of a regulatory inspection at its Oral Solid Dosage (OSD) Unit-2 facility in Valthera, Gujarat. The inspection was conducted by Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) on October 6-7, 2025.

Inspection Details

Significance of the Inspection

The successful completion of the NAFDAC inspection is a significant achievement for Concord Biotech, highlighting several key aspects of the company's operations:

1. Quality Assurance: The inspection underscores Concord Biotech's commitment to maintaining high standards of quality in its manufacturing processes.

2. Regulatory Compliance: Successfully passing the inspection demonstrates the company's adherence to international regulatory requirements, particularly those of Nigeria's drug regulatory authority.

3. Global Market Access: A positive outcome from NAFDAC inspection could potentially facilitate Concord Biotech's access to the Nigerian pharmaceutical market, one of the largest in Africa.

4. Operational Excellence: The successful inspection reflects the company's focus on operational excellence and its ability to meet rigorous regulatory standards.

Company Statement

In its regulatory filing, Concord Biotech stated, "This achievement underscores our unwavering commitment to upholding the highest standards of quality, safety, and regulatory compliance across all aspects of our operations. It reflects our dedication to excellence and our continued focus on meeting the rigorous requirements of global regulatory authorities."

The successful NAFDAC inspection at Concord Biotech's Valthera facility demonstrates the company's strong position in maintaining international quality standards and regulatory compliance. This development could potentially strengthen the company's foothold in the global pharmaceutical market, particularly in Africa.

Investors and stakeholders may view this as a positive indicator of the company's operational standards and its potential for expansion in international markets. However, as with all regulatory inspections, it's important to note that this is part of ongoing compliance processes in the pharmaceutical industry.

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.