Smruthi Organics Receives 'Attestation of Inspection' from EDQM for Amlodipine Besilate Manufacturing Facility
Smruthi Organics Limited has received an ‘Attestation of Inspection’ from the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, following the inspection conducted at its flagship API manufacturing facility, Unit II in Solapur, Maharashtra, from 27 August 2025 to 29 August 2025. The attestation confirms that the facility operates in compliance with the application submitted to EDQM for Amlodipine Besilate and meets the applicable European Good Manufacturing Practice (EU GMP) requirements under the CEP and European regulatory framework. This represents successful closure of the EDQM inspection process. The formal Certificate of Suitability (CEP) is currently under final administrative processing by EDQM. The Company will update the exchanges upon receipt of the CEP. Smruthi Organics Limited remains committed to sustained regulatory excellence, quality leadership, and long-term value creation for its stakeholders.
Key Highlights
- Smruthi Organics received 'Attestation of Inspection' from EDQM for its Amlodipine Besilate manufacturing facility.
- The inspection, conducted from 27 August 2025 to 29 August 2025, confirmed compliance with EU GMP requirements under the CEP framework.
- This development significantly strengthens Smruthi Organics' position in regulated European and allied markets.
- The positive inspection outcome is expected to support business expansion, improve customer confidence, and create additional opportunities in regulated export markets.
- The formal Certificate of Suitability (CEP) is under final administrative processing by EDQM.