Medispray Laboratories Private Limited

Medispray Laboratories Private Limited, incorporated on February 21, 1992, is a private Indian pharmaceutical company headquartered in Goa. The company is registered under the Corporate Identification Number (CIN) U52311GA1992PTC002801. Its authorized share capital is ₹51,000,000, with a paid-up capital of ₹510,200. The registered office is located at Plot No. 344/345, Kundaim Industrial Estate, Kundaim, Goa 403 115.

Medispray Laboratories specializes in the manufacturing and export of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company's product portfolio is concentrated in two therapeutic categories: Respiratory (53.0%) and CNS & Psychiatric (47.0%). Notably, Medispray holds the number one market position in Citalopram and Escitalopram, with respective market shares of 1.5% and 2.0%. The top five products—Salbutamol, Citalopram, Escitalopram, Salmeterol, and Fluticasone—account for 89.3% of the company's total export value.

Medispray Laboratories operates manufacturing facilities in Goa, India, specifically within the Kundaim Industrial Estate. The plant specializes in the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. While specific production capacities are not publicly disclosed, the company's substantial export value of $16.4 million USD over 407 shipments indicates a significant manufacturing capability.

As of October 2022, Sanjay Kumar Mishra serves as the Managing Director of Medispray Laboratories Private Limited. Piyush Vadilal Salot was appointed as the Chief Financial Officer (CFO) in September 2023. Other key executives include Dinesh Ramniranjan Jain, who joined as a Director in November 2019, and Anisha Naresh Udeshi, appointed as a Director in August 2021. The company's leadership team is responsible for overseeing operations, financial management, and strategic direction.

Medispray Laboratories Private Limited has established a presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company's export data indicates a diversified product range, suggesting compliance with international regulatory standards. However, specific details regarding regulatory filings, approvals, and market access status in these regions are not publicly available. The company's focus on finished pharmaceutical formulations aligns with the stringent requirements of these markets, indicating a commitment to quality and regulatory compliance.

Medispray Laboratories has expanded its reach into emerging markets across Africa, Latin America, and Southeast Asia. The company's export data reflects a strategic approach to penetrating these regions, likely facilitated by obtaining WHO prequalification for certain products. This prequalification enables access to international procurement programs and enhances the company's credibility in these markets. While specific details on market penetration strategies are limited, the company's product portfolio and export activities suggest a proactive approach to emerging market expansion.

Medispray Laboratories demonstrates a diversified geographic strategy, exporting to multiple regions worldwide. The company's substantial export value and the concentration of its product portfolio in two therapeutic categories indicate a focused approach to market expansion. This diversification helps mitigate concentration risk and positions the company to leverage growth opportunities across different markets. The strategic direction appears to be centered on strengthening its presence in both established and emerging markets, aligning with global demand for quality pharmaceutical products.

Specific details regarding Medispray Laboratories' FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly available. The company's focus on finished pharmaceutical formulations suggests adherence to international quality standards, which is a prerequisite for FDA approvals. However, without publicly accessible records, a comprehensive assessment of the company's FDA status cannot be conducted.

Medispray Laboratories' export data indicates a commitment to quality standards, likely including compliance with WHO Good Manufacturing Practices (GMP) and EU GMP certifications. While specific certifications are not publicly disclosed, the company's focus on finished pharmaceutical formulations aligns with the stringent requirements of these standards. Obtaining WHO prequalification for certain products further supports the company's adherence to international quality norms.

Medispray Laboratories holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO) and has approvals from state drug controllers, facilitating its operations within India. The company's export data reflects compliance with Indian regulatory requirements, including obtaining export No Objection Certificates (NOCs) for international shipments. These regulatory compliances ensure the company's products meet both domestic and international standards.

As of March 2026, there are no publicly available records indicating any Form 483 observations, warning letters, or import alerts issued to Medispray Laboratories Private Limited. The absence of such regulatory actions suggests that the company maintains a strong compliance record with regulatory authorities. However, without access to detailed inspection histories, a comprehensive assessment cannot be made.

Medispray Laboratories operates in a competitive landscape with several key players in the pharmaceutical industry. While specific competitors are not identified in the available data, the company's focus on respiratory and CNS & psychiatric products places it in competition with other manufacturers specializing in these therapeutic areas. The company's market leadership in Citalopram and Escitalopram indicates a strong position in the CNS segment. A detailed market share comparison and head-to-head analysis would require access to proprietary market research data.

Medispray Laboratories' key differentiators include its concentrated product portfolio, with the top five products accounting for 89.3% of its total export value, and its market leadership in Citalopram and Escitalopram. The company's focus on finished pharmaceutical formulations aligns with global demand for quality products. Additionally, the company's expansion into emerging markets and adherence to international quality standards, such as WHO prequalification, enhance its competitive advantages.

Medispray Laboratories' current strategic direction appears to focus on the production and export of generic pharmaceutical formulations, with a strong emphasis on respiratory and CNS & psychiatric products. The company's market leadership in specific products and its expansion into emerging markets suggest a strategy aimed at leveraging growth opportunities in both established and developing regions. Future outlooks would depend on the company's ability to adapt to evolving market dynamics and regulatory landscapes.

Medispray Laboratories demonstrates a strong track record in the pharmaceutical industry, with a substantial export volume of $16.4 million USD over 407 shipments. The company's focus on finished pharmaceutical formulations and its market leadership in specific products indicate reliability and consistency in product quality. While specific reliability indicators are not publicly disclosed, the company's adherence to international quality standards and regulatory compliances suggest a dependable supply chain.

Importers should verify the following certifications when considering Medispray Laboratories as a supplier:

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

• WHO-GMP Certification: Verify the company's adherence to World Health Organization Good Manufacturing Practices, which can be confirmed through the WHO's official website or by contacting the company directly.

• EU GMP Certification: Ensure the company holds European Union Good Manufacturing Practices certification, which can be verified through the European Medicines Agency (EMA) or the company's official communications.

• ISO Certification: Check for ISO certifications related to quality management systems, which can be verified through the International Organization for Standardization's official website or by contacting the company.

When conducting due diligence on Medispray Laboratories Private Limited, consider the following steps:

• Verify Regulatory Compliance: Confirm the company's compliance with relevant regulatory bodies, including the FDA, WHO, EU, and CDSCO.

• Assess Financial Health: Review the company's financial statements and balance sheets to evaluate financial stability.

• Evaluate Product Quality: Request samples and conduct quality assessments to ensure product standards meet your requirements.

• Check Supply Chain Reliability: Assess the company's logistics and delivery capabilities to ensure timely and consistent supply.

• Review Certifications: Verify all relevant certifications, including GMP and ISO, to ensure adherence to international standards.

By following this checklist, importers can make informed decisions regarding potential partnerships with Medispray Laboratories Private Limited.