Anondita Medicare Achieves Major Global Regulatory Milestone with MDSAP Certification

Mumbai, January 13, 2026:Anondita Medicare Limited (NSE – SME: ANONDITA) has received the Medical Device Single Audit Program (MDSAP) Certification under ISO 13485:2016 from DQS Medizinprodukte GmbH, a globally recognised certification authority 

 

The certification authorises the Company to sell, distribute, and market its products in five regulated international jurisdictions – Australia, Brazil, Canada, Japan, and the United States of America, providing a single, harmonised regulatory pathway into some of the world’s most stringent medical device markets.

 

The MDSAP certification marks a transformational leap in Anondita Medicare’s global growth journey. By meeting the unified regulatory requirements of multiple global regulators, the Company has significantly enhanced its regulatory credibility, compliance strength, and international market readiness.

 

 

Anondita Medicare Limited, engaged in the manufacturing of male and female condoms, this approval substantially strengthens its ability to access regulated international markets, paving the way for:

• Expanded export opportunities
• Entry into premium and compliance-driven healthcare markets
• Improved acceptance by global distributors, institutions, and government procurement agenciesommentary

 

Commenting on the development, Mr. Anupam Ghosh, Managing Director, Anondita Medicare Limited, said: “The MDSAP certification represents a critical step in strengthening our global regulatory foundation and manufacturing credibility. It enhances our visibility into long-term revenues from regulated international markets, simplifies multi-country regulatory requirements, and enables us to scale our export strategy more efficiently.

 

This milestone materially improves our competitive positioning against peers by aligning our operations with the highest international quality and compliance standards. We believe this certification will support strategically international growth and sustainable value creation for all stakeholders.”

 

Anondita Medicare Limited, is an Indian manufacturer of male and female condoms, operating under its flagship brand “COBRA.” The company runs its own manufacturing facility and follows a quality-driven, compliant production model. The company is led by Mr. Anupam Ghosh, who brings over 25 years of experience in the healthcare and contraceptive products industry. His deep domain expertise, entrepreneurial background, and execution capability provide strong leadership and strategic direction to the company. 

 

With a strong domestic presence, particularly in North India, Anondita Medicare is actively expanding its geographical footprint across India and international markets. Ongoing initiatives such as UN qualification, automation-led capacity enhancement, and patented female condom products position the company for scalable growth and long-term value creation.

 

In H1 FY26, the Company reported revenue from operations of ₹54.10 crore, EBITDA of ₹19.20 crore with a margin of 35.49%, and PAT of ₹13.02 crore, translating into a PAT margin of 24.06%.

 

Certain statements in this document that are not historical facts are forward looking statements. Such forward-looking statements are subject to certain risks and uncertainties like government actions, local, political or economic developments, technological risks, and many other factors that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. The Company will not be in any way responsible for any action taken based on such statements and undertakes no obligation to publicly update these forward-looking statements to reflect subsequent events or circumstances 

 

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