Smruthi organics Limited has achieved a major regulatory milestone with the receipt of a Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM). This certification completes the regulatory approval process that began with the company's successful EU GMP compliance inspection for its Amlodipine Besilate manufacturing operations.

EDQM Inspection and Certification Process

The regulatory journey began with a comprehensive EDQM inspection conducted at the company's flagship API manufacturing facility, Unit II, located in Solapur, Maharashtra. The evaluation took place over three days from 27 August 2025 to 29 August 2025, which resulted in an Attestation of Inspection confirming compliance with stringent European Good Manufacturing Practice standards.

CEP Certificate Significance

The CEP certifies that the quality of the Amlodipine Besilate substance complies with the requirements of the European Pharmacopoeia. This certification enables the company to supply this product to pharmaceutical manufacturers in European markets and other regions that recognize the CEP certification. The certificate represents the successful completion of the EDQM regulatory approval process that was initiated following the positive inspection outcome.

Market Expansion Opportunities

This regulatory achievement significantly strengthens the company's position in regulated European and allied markets while enhancing credibility with global customers. The CEP certification is expected to support several key business objectives:

• Direct supply capabilities to European pharmaceutical manufacturers
• Enhanced market access in regions recognizing CEP certification
• Improved competitive positioning in regulated export markets
• Strengthened regulatory portfolio for future product approvals

Regulatory Compliance and Future Outlook

The company has formally notified the stock exchanges about receiving the CEP certificate under Regulation 30 of SEBI (LODR) Regulations, 2015. This milestone strengthens the company's regulatory portfolio and demonstrates its commitment to maintaining the highest quality manufacturing standards. The successful completion of the EDQM certification process positions Smruthi Organics Limited to capitalize on expanded opportunities in the European pharmaceutical market while continuing its focus on regulatory excellence and long-term value creation for stakeholders.

Smruthi Organics Limited has announced its unaudited financial results for the third quarter ended December 31, 2025, following approval by the Board of Directors at a meeting held on February 13, 2026. The pharmaceutical company, specializing in bulk drugs and drug intermediates, submitted these results under Regulation 33 of SEBI Listing Obligations and Disclosure Requirements Regulations, 2015.

Board Meeting and Regulatory Compliance

The Board meeting commenced at 10:30 am and concluded at 11:15 am on February 13, 2026. The company submitted the unaudited financial results along with a Limited Review Report issued by statutory auditors Gokhale & Sathe, Chartered Accountants. The results have been made available on the company's website at www.smruthiorganics.com .

Financial Performance Overview

The company's financial performance for Q3 FY26 presents mixed quarterly results but demonstrates strong nine-month growth across key metrics.

Quarterly Results Analysis

For the third quarter of FY26, Smruthi Organics reported revenue from operations of ₹2229.11 lakhs, representing a decline from ₹3124.97 lakhs in the corresponding quarter of the previous year. Despite the revenue decline, the company maintained profitability with a net profit of ₹139.79 lakhs for the quarter, though this was lower than the ₹148.07 lakhs achieved in Q3 FY25.

Nine-Month Performance Highlights

The nine-month performance demonstrates remarkable improvement, with net profit showing growth of 77.00% to ₹235.87 lakhs from ₹133.28 lakhs in the corresponding period of the previous year. This strong performance resulted in earnings per share of ₹2.06 for the nine-month period, significantly higher than ₹1.16 in the previous year.

Segment Performance

The company operates primarily in two segments - API (Active Pharmaceutical Ingredients) and Formulations.

The API segment remains the primary revenue driver, though it experienced a decline in the current quarter. The formulation division reported a loss of ₹32.21 lakhs for the nine-month period.

Impact of New Labour Codes

A significant development during the quarter was the implementation of India's New Labour Codes effective November 21, 2025. The company recognized an exceptional expense of ₹45.17 lakhs towards gratuity due to changes in the definition of wages under the new framework. This impact has been treated as an exceptional item in the financial statements.

Key Financial Metrics

The results were reviewed by the Audit Committee and approved by the Board of Directors, with statutory auditors conducting a limited review of the unaudited financial results.