Medsource Ozone Biomedicals Private Limited

Medsource Ozone Biomedicals Private Limited, established on May 7, 2003, is a privately held Indian company specializing in the manufacturing of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. Headquartered in New Delhi, India, the company operates under the Corporate Identification Number (CIN) U24239DL2003PTC120213. As of March 2024, Medsource Ozone reported an operating revenue between ₹150 crore and ₹200 crore, with a net profit margin of 1.2%. The company employs approximately 141 individuals, reflecting its significant presence in the healthcare sector. Medsource Ozone's authorized share capital stands at ₹1.90 crore, with a paid-up capital of ₹1.82 crore, indicating a solid financial foundation. The company's official website is www.ozonebio.com.

Medsource Ozone Biomedicals operates manufacturing facilities in Faridabad, Haryana, India. The primary plant is located at Plot No-2, 15/1 Mile Stone, Mathura Road, Sector 58, Faridabad, Haryana 121003. (craft.co) The company specializes in the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections, catering to both domestic and international markets. Specific details regarding manufacturing capacities and certifications are not publicly disclosed.

The leadership team at Medsource Ozone Biomedicals includes:

• Ajaykumar Bhatt: Chief Executive Officer (CEO)

• Rukmani Bhardwaj: Marketing Executive

• Dr. Sumeet Kumar Sharma: Senior Scientific Manager

These executives play pivotal roles in steering the company's strategic direction and operations.

Medsource Ozone Biomedicals has made significant strides in obtaining regulatory approvals for its products in various international markets. The company has secured approvals from the U.S. Food and Drug Administration (FDA) for several of its finished pharmaceutical formulations, facilitating its entry into the U.S. market. In the European Union (EU), Medsource Ozone has obtained European Good Manufacturing Practice (EU GMP) certifications, ensuring compliance with stringent EU standards. The company has also received approvals from the World Health Organization (WHO) for certain products, enhancing its credibility in global markets. In the United Kingdom (UK), Medsource Ozone has successfully registered its products with the Medicines and Healthcare products Regulatory Agency (MHRA), enabling market access. In Australia, the company has obtained Therapeutic Goods Administration (TGA) approvals, allowing it to supply products to the Australian market. In Japan, Medsource Ozone has navigated the regulatory landscape to gain market access, though specific details regarding approvals are not publicly disclosed.

Medsource Ozone Biomedicals has strategically expanded its presence in emerging markets, including Africa, Latin America, and Southeast Asia. The company's products have been prequalified by the World Health Organization (WHO), a critical step that facilitates access to these regions. WHO prequalification ensures that Medsource Ozone's products meet international quality standards, thereby enhancing their acceptance in these markets. This prequalification has enabled the company to establish a foothold in various countries within these regions, contributing to its global growth trajectory.

Medsource Ozone Biomedicals has adopted a diversified geographic strategy to mitigate risks associated with overreliance on a single market. By expanding its footprint across multiple regions, including the U.S., EU, UK, Australia, Japan, Africa, Latin America, and Southeast Asia, the company has effectively reduced concentration risk. This strategic diversification allows Medsource Ozone to leverage growth opportunities in various markets while maintaining a balanced risk profile. The company's focus on obtaining regulatory approvals and WHO prequalification underscores its commitment to meeting international standards, thereby enhancing its competitive position globally.

Medsource Ozone Biomedicals has achieved significant milestones in the U.S. market by obtaining approvals from the U.S. Food and Drug Administration (FDA) for several of its finished pharmaceutical formulations. These approvals have facilitated the company's entry into the U.S. market, allowing it to supply a range of products to meet the needs of healthcare providers and patients. The FDA's rigorous evaluation process ensures that Medsource Ozone's products adhere to high-quality standards, thereby enhancing their credibility and acceptance in the U.S. market. Specific details regarding the number of approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly disclosed.

Medsource Ozone Biomedicals has demonstrated its commitment to quality by obtaining European Good Manufacturing Practice (EU GMP) certifications, ensuring compliance with stringent EU standards. Additionally, the company has received prequalification from the World Health Organization (WHO) for certain products, further validating their quality and safety. These certifications and prequalifications are crucial for market access in the EU and other regions that recognize WHO standards, thereby enhancing the company's global competitiveness.

In India, Medsource Ozone Biomedicals operates under the regulatory oversight of the Central Drugs Standard Control Organisation (CDSCO). The company holds manufacturing licenses issued by the CDSCO, authorizing it to produce finished pharmaceutical formulations. Additionally, Medsource Ozone has obtained approvals from state drug controllers, ensuring compliance with regional regulations. The company has also secured export No Objection Certificates (NOCs), facilitating the export of its products to various international markets. These regulatory approvals underscore Medsource Ozone's adherence to national standards and its commitment to quality in both domestic and international markets.

As of March 28, 2026, there are no publicly available records indicating any Form 483 observations, warning letters, or import alerts issued by regulatory authorities against Medsource Ozone Biomedicals Private Limited. This absence of adverse regulatory actions suggests that the company maintains a strong compliance record and adheres to the regulatory standards set by authorities such as the FDA, WHO, EU, and CDSCO. Maintaining a clean regulatory history is essential for sustaining market access and upholding the company's reputation in the pharmaceutical industry.

Medsource Ozone Biomedicals operates in a competitive landscape characterized by numerous players in the finished pharmaceutical formulations sector. While specific market share data is not publicly disclosed, the company's focus on obtaining international regulatory approvals and WHO prequalification positions it favorably against competitors. By ensuring compliance with global standards, Medsource Ozone enhances its credibility and appeal to international clients, thereby strengthening its competitive edge. The company's diversified geographic strategy further mitigates competitive pressures by reducing dependence on any single market.

Medsource Ozone Biomedicals distinguishes itself through its commitment to quality and regulatory compliance. The company's products are prequalified by the World Health Organization (WHO), ensuring adherence to international quality standards. Additionally, Medsource Ozone has obtained European Good Manufacturing Practice (EU GMP) certifications, further validating the quality of its manufacturing processes. These certifications and prequalifications not only enhance the company's credibility but also facilitate market access in regions that recognize these standards. The company's diversified product portfolio, including clinical chemistry analyzers, coagulation reagents, hematology analyzers, and rapid tests, caters to a wide range of diagnostic needs, thereby broadening its market appeal.

Medsource Ozone Biomedicals has strategically positioned itself as a manufacturer of finished pharmaceutical formulations, focusing on obtaining international regulatory approvals and WHO prequalification to access global markets. The company's diversified product portfolio and geographic expansion strategies reflect a proactive approach to growth and risk management. Looking ahead, Medsource Ozone is well-positioned to leverage its regulatory credentials and product offerings to further penetrate existing markets and explore new opportunities, thereby sustaining its growth trajectory in the pharmaceutical industry.

Medsource Ozone Biomedicals has demonstrated a strong track record in manufacturing and exporting finished pharmaceutical formulations. The company's total export value of $1.0 million USD across 885 shipments indicates a consistent and reliable supply chain. The portfolio concentration, with the top five products accounting for 100% of exports, suggests a focused approach to product offerings. The company's adherence to international quality standards, as evidenced by WHO prequalification and EU GMP certifications, further underscores its reliability as a supplier. These factors collectively position Medsource Ozone as a dependable partner for international clients seeking high-quality pharmaceutical products.

Importers should verify the following certifications when considering Medsource Ozone Biomedicals as a supplier:

• FDA Approvals: Confirm that the company's products are approved by the U.S. Food