Smruthi Organics Receives EU GMP Compliance Attestation from EDQM for Amlodipine Besilate Facility
Smruthi Organics Limited has received an Attestation of Inspection from EDQM confirming EU GMP compliance for its Amlodipine Besilate manufacturing facility in Solapur, Maharashtra. The inspection was conducted from 27 August 2025 to 29 August 2025 at Unit II facility. This achievement strengthens the company's position in regulated European markets and enhances credibility with global customers. The formal Certificate of Suitability (CEP) is currently under final administrative processing by EDQM.

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Smruthi organics Limited has achieved a significant regulatory milestone with the receipt of an Attestation of Inspection from the European Directorate for the Quality of Medicines & HealthCare (EDQM). This certification confirms the company's compliance with stringent European Good Manufacturing Practice standards for its Amlodipine Besilate manufacturing operations.
EDQM Inspection Details
The EDQM inspection was conducted at the company's flagship API manufacturing facility, Unit II, located in Solapur, Maharashtra. The comprehensive evaluation took place over three days from 27 August 2025 to 29 August 2025.
| Parameter: | Details |
|---|---|
| Inspection Authority: | European Directorate for the Quality of Medicines & HealthCare (EDQM) |
| Facility Location: | Unit II, Solapur, Maharashtra |
| Inspection Period: | 27 August 2025 to 29 August 2025 |
| Product Scope: | Amlodipine Besilate |
| Compliance Framework: | European Good Manufacturing Practice (EU GMP) under CEP |
Regulatory Compliance Achievement
The attestation confirms that the facility operates in full compliance with the application submitted to EDQM for Amlodipine Besilate and meets all applicable European Good Manufacturing Practice requirements under the CEP and European regulatory framework. This represents the successful closure of the EDQM inspection process, marking a crucial step in the company's regulatory approval journey.
Business Impact and Market Position
The company believes this development significantly strengthens its position in regulated European and allied markets while enhancing credibility with global customers. The positive inspection outcome is expected to support several key business objectives:
- Business expansion in European markets
- Improved customer confidence and trust
- Creation of additional opportunities in regulated export markets
- Enhanced competitive positioning in the pharmaceutical sector
Next Steps and Future Outlook
The formal Certificate of Suitability (CEP) is currently under final administrative processing by EDQM. The company has committed to updating the stock exchanges upon receipt of the CEP, which will complete the regulatory approval process. Smruthi Organics Limited emphasized its continued commitment to sustained regulatory excellence, quality leadership, and long-term value creation for stakeholders.
This regulatory achievement positions the company to capitalize on opportunities in the European pharmaceutical market while maintaining its focus on quality manufacturing standards and compliance excellence.
Historical Stock Returns for Smruthi Organics
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
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| -100.00% | -100.00% | -100.00% | -100.00% | -100.00% | -100.00% |





























