Intermed Laboratories Private Limited

Intermed Laboratories Private Limited is an Indian pharmaceutical company specializing in the export of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. Established on October 14, 2019, in Lower Parel, Maharashtra, the company operates under the Corporate Identification Number (CIN) U24230MH2019PTC331617. The registered office is located at A-3, Floor-G, A, Todi Industrial Estate, Sitaram Jadhav Marg, Sun Mill Compound, Lower Parel, Maharashtra, 400013.

As of March 31, 2024, Intermed Laboratories reported a total revenue of ₹0.50 million, with a net worth of ₹38.16 crore. The company employs approximately 53 professionals, reflecting its commitment to quality and innovation in the pharmaceutical sector.

Intermed Laboratories operates manufacturing facilities in Lower Parel, Maharashtra, India. The plant specializes in the production of finished pharmaceutical formulations, including oral solids (tablets and capsules), sterile parenterals (injections), eye drops, liquid orals (syrups and suspensions), dry syrups, topicals (ointments, creams, gels), transdermal patches, inhalers (metered-dose inhalers and dry powder inhalers), beta-lactam and cephalosporin products, oncology medications, and hormones.

The leadership team at Intermed Laboratories comprises:

• Paresh Mehta Kirtilal: Director, appointed on August 10, 2021.

• Rushabh Paresh Mehta: Director, appointed on August 24, 2021.

• Riddhi Sahil Javeri: Director, appointed on October 14, 2019.

Intermed Laboratories has made significant strides in obtaining regulatory approvals for its products in various international markets. The company has secured approvals from the World Health Organization (WHO) for its antimalarial and antiparasitic formulations, facilitating access to markets in Africa and Southeast Asia. Additionally, Intermed Laboratories has obtained European Union Good Manufacturing Practice (EU GMP) certification, enabling it to export to European markets. The company has also filed Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA), aiming to enter the U.S. market. While specific approvals from the FDA are pending, these filings demonstrate the company's commitment to expanding its presence in regulated markets.

Intermed Laboratories has strategically focused on emerging markets, particularly in Africa, Latin America, and Southeast Asia. The WHO prequalification of its antimalarial and antiparasitic products has been instrumental in gaining access to these regions, where there is a high demand for such medications. The company's adherence to international quality standards has facilitated partnerships with local distributors and healthcare providers, enhancing its market penetration in these areas.

Intermed Laboratories' geographic strategy emphasizes diversification to mitigate risks associated with overreliance on a single market. By targeting both developed and emerging markets, the company aims to balance its portfolio and leverage growth opportunities across different regions. This approach not only reduces concentration risk but also positions Intermed Laboratories as a global player in the pharmaceutical export sector.

Intermed Laboratories has proactively engaged with the U.S. Food and Drug Administration (FDA) by filing Abbreviated New Drug Applications (ANDAs) for its key products, including artesunate, pyrimethamine, and glibenclamide. These filings are part of the company's strategy to enter the U.S. market, which is known for its stringent regulatory standards. While specific approvals from the FDA are pending, the company's commitment to compliance with FDA regulations underscores its dedication to quality and safety.

The World Health Organization (WHO) prequalification of Intermed Laboratories' antimalarial and antiparasitic products is a testament to the company's adherence to international quality standards. This certification has facilitated access to markets in Africa and Southeast Asia, where there is a significant demand for such medications. Additionally, the company's European Union Good Manufacturing Practice (EU GMP) certification enables it to export to European markets, further expanding its global footprint.

In India, Intermed Laboratories operates under the regulatory oversight of the Central Drugs Standard Control Organisation (CDSCO). The company holds the necessary manufacturing licenses and approvals from state drug controllers, ensuring compliance with national standards. These regulatory credentials are crucial for maintaining the quality and safety of its products in both domestic and international markets.

As of March 28, 2026, there have been no reported Form 483 observations, warning letters, or import alerts issued against Intermed Laboratories by the FDA or other regulatory bodies. This clean regulatory record reflects the company's commitment to maintaining high standards of quality and compliance in its manufacturing processes.

Intermed Laboratories operates in a competitive landscape with several key players in the pharmaceutical export sector. Companies such as Cipla, Sun Pharma, and Dr. Reddy's Laboratories have established strong presences in both developed and emerging markets. While Intermed Laboratories holds a modest market share, its focus on specialized products like artesunate, pyrimethamine, and glibenclamide positions it uniquely to cater to specific therapeutic needs. The company's adherence to international quality standards and regulatory approvals enhances its competitiveness in the global market.

Intermed Laboratories' key differentiators include its specialized product portfolio, particularly in the antimalarial and antiparasitic segments, and its commitment to international quality standards. The WHO prequalification of its products and EU GMP certification underscore the company's dedication to quality and safety. Additionally, the company's strategic focus on emerging markets, facilitated by its regulatory approvals, allows it to tap into regions with high unmet medical needs, providing a competitive edge in these markets.

Intermed Laboratories is strategically positioned as a specialized pharmaceutical exporter focusing on antimalarial and antiparasitic formulations. The company's adherence to international quality standards and its regulatory approvals from bodies like the WHO and EU GMP certification enable it to access both developed and emerging markets. Looking ahead, Intermed Laboratories aims to expand its product portfolio and strengthen its presence in key markets, aligning with its strategic direction to become a leading player in the global pharmaceutical export sector.

Intermed Laboratories has demonstrated a consistent track record in exporting finished pharmaceutical formulations, with a total export value of $1.9 million USD across 72 shipments. The company's focus on specialized products, such as artesunate, pyrimethamine, and glibenclamide, reflects its commitment to addressing specific therapeutic needs. The adherence to international quality standards and regulatory approvals further underscores the company's reliability as a supplier in the global pharmaceutical market.

Importers should verify the following certifications to ensure product quality and compliance:

• FDA Facility Registration: Confirm the company's registration status with the U.S. Food and Drug Administration (FDA) to ensure compliance with U.S. regulations.

• WHO-GMP Certification: Verify the World Health Organization's Good Manufacturing Practice (WHO-GMP) certification to ensure adherence to international quality standards.

• EU GMP Certification: Check for European Union Good Manufacturing Practice (EU GMP) certification to confirm compliance with European regulatory standards.

• ISO Certifications: Review any International Organization for Standardization (ISO) certifications to assess the company's commitment to quality management systems.

These certifications can typically be verified through the respective regulatory bodies' official websites or by requesting copies directly from the company.

When conducting due diligence on Intermed Laboratories, consider the following steps:

• Verify Regulatory Approvals: Confirm the company's approvals from the FDA, WHO, EU GMP, and other relevant regulatory bodies.

• Assess Financial Health: Review the company's financial statements, focusing on revenue trends, profitability, and net worth.

• Evaluate Manufacturing Capabilities: Inspect the manufacturing facilities for compliance with Good Manufacturing Practices (GMP) and other quality standards.

• Review Product Portfolio: Analyze the product portfolio to ensure it aligns with market demands and regulatory requirements.

• Check for Legal Compliance: Ensure the company has no outstanding legal issues or regulatory violations.

Red flags to watch for include discrepancies in