Concord Biotech

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

Concord Biotech announced the completion of an EU GMP (Good Manufacturing Practice) inspection at its API (Active Pharmaceutical Ingredient) facility located in Limbassi. The inspection process has been concluded at this manufacturing site.

Concord Biotech Limited reported quarterly revenues of INR 204 crores compared to INR 216 crores in the same period last year, representing a 5% decline. The API business segment saw a 10% decline to INR 153.8 crores, while formulation business grew 12% to INR 50.2 crores. EBITDA dropped to INR 61 crores from INR 81 crores, with margins at 30.1% versus 37.7% previously. The company attributed the revenue decline primarily to customer procurement pattern lumpiness, noting that the preceding quarter had exceptionally high sales. EBITDA margins were impacted by commercialization costs of approximately INR 12-13 crores from the new injectable facility in Valthera. Excluding these costs, EBITDA margins stood at approximately 37%, consistent with the same quarter last year. The company received US FDA approval for teriflunomide tablets and successfully passed multiple regulatory inspections including US FDA, European GMP, and Russian GMP. Concord incorporated two new subsidiaries: Stellon Biotech Inc. for US market operations and Concord Lifegen Limited for domestic marketing. The company initiated CDMO business sales to the US market and launched two products from its injectable facility in the domestic market. Management expects the injectable facility costs to normalize as revenues scale up through FY26.