Smruthi Organics Receives EU GMP Compliance Attestation from EDQM for Amlodipine Besilate Facility

1 min read     Updated on 04 Mar 2026, 07:48 AM
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Overview

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.

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Smruthi Organics Reports Q3 FY26 Results Following Board Meeting Approval

3 min read     Updated on 13 Feb 2026, 11:57 AM
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Reviewed by
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Overview

Smruthi Organics Limited reported Q3 FY26 financial results following Board approval on February 13, 2026. While quarterly net profit declined to ₹139.79 lakhs from ₹148.07 lakhs year-on-year, nine-month performance showed strong growth with 77% increase in net profit to ₹235.87 lakhs. The company recognized an exceptional expense of ₹45.17 lakhs due to new Labour Codes implementation.

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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 .

Meeting Details: Information
Date: February 13, 2026
Duration: 10:30 am to 11:15 am
Auditors: Gokhale & Sathe, Chartered Accountants
Regulation: SEBI Regulation 33

Financial Performance Overview

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

Metric: Q3 FY26 Q3 FY25 Change Nine Months FY26 Nine Months FY25 Change
Revenue from Operations: ₹2229.11 lakhs ₹3124.97 lakhs -28.70% ₹7287.84 lakhs ₹8791.34 lakhs -17.10%
Net Profit: ₹139.79 lakhs ₹148.07 lakhs -5.60% ₹235.87 lakhs ₹133.28 lakhs +77.00%
Earnings Per Share: ₹1.22 ₹1.29 -5.40% ₹2.06 ₹1.16 +77.60%

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.

Segment: Q3 FY26 Revenue Q3 FY25 Revenue Nine Months FY26 Nine Months FY25
API: ₹2225.95 lakhs ₹3119.84 lakhs ₹7271.68 lakhs ₹8762.36 lakhs
Formulation: -₹0.56 lakhs ₹5.15 lakhs ₹20.92 lakhs ₹29.44 lakhs

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

Financial Parameter: Q3 FY26 Q3 FY25
Cost of Materials Consumed: ₹1001.54 lakhs ₹1550.04 lakhs
Employee Benefit Expenses: ₹453.98 lakhs ₹443.19 lakhs
Finance Costs: ₹25.25 lakhs ₹50.84 lakhs
Paid-up Capital: ₹1144.63 lakhs ₹1144.63 lakhs

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.

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