Appasamy Associates Private Limited

Appasamy Associates Private Limited, incorporated on May 29, 2019, is a private Indian company specializing in the manufacture of medical, precision, and optical instruments. The company is registered under the Corporate Identification Number (CIN) U33201TN2019PTC129614 and is headquartered at No. 20, 1st Street SBI Officers Colony, Arumbakkam, Chennai, Tamil Nadu, 600106. As of the latest available data, Appasamy Associates has an authorized share capital of ₹32,00,00,000 and a paid-up capital of ₹31,37,75,170. The company is classified as a private, non-government entity and is not listed on any stock exchange. The most recent Annual General Meeting (AGM) was held on August 13, 2025, and the latest balance sheet was filed on March 31, 2025.

Appasamy Associates operates manufacturing facilities in Chennai, Tamil Nadu, India. While specific details regarding plant capacities and specializations are not publicly disclosed, the company's focus on medical, precision, and optical instruments suggests that its facilities are equipped to produce a range of ophthalmic devices and related products. The company's subsidiaries, such as Ai Optics Private Limited and Appasamy Ocular Devices Private Limited, indicate a specialization in optical and ophthalmic products.

The leadership team of Appasamy Associates Private Limited includes:

• Senthil Kumar Rathsarathy: Managing Director
• Annaswamy Vaidheesh: Additional Director
• Himanshu Vishnu Nema: Nominee Director

These individuals bring a wealth of experience in the medical and optical instrument manufacturing sectors, contributing to the company's strategic direction and operational success.

Appasamy Associates Private Limited's export activities, as per TransData Nexus proprietary trade data, include a total export value of $290,000 USD across 24 shipments, with products spanning two therapeutic categories. The top five products exported are a medical device valued at $183,000 USD and prednisone at $107,000 USD. The primary therapeutic categories are Medical Devices & Diagnostics (63.0%) and Respiratory (37.0%). However, specific details regarding regulatory filings, approvals, and market access status in the US, EU, UK, Australia, and Japan are not publicly available. The company's focus on medical devices and respiratory products suggests potential interest in these regulated markets, but further information is needed to assess their market presence and compliance status.

Appasamy Associates Private Limited's export data indicates a concentration in medical devices and respiratory products, which are critical in emerging markets across Africa, Latin America, and Southeast Asia. While the company's WHO prequalification status is not publicly disclosed, obtaining such certification would enhance its ability to supply products to these regions, where access to quality medical devices is essential. The company's existing export activities suggest a strategic interest in expanding its presence in these emerging markets.

Appasamy Associates Private Limited's export data reveals a focus on medical devices and respiratory products, with a total export value of $290,000 USD across 24 shipments. The primary therapeutic categories are Medical Devices & Diagnostics (63.0%) and Respiratory (37.0%). This concentration indicates a strategic emphasis on these product areas. However, the lack of detailed geographic distribution data limits the assessment of the company's diversification and concentration risks. Further information is needed to evaluate the company's geographic strategy and its approach to mitigating potential risks associated with market concentration.

Specific details regarding Appasamy Associates Private Limited's FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly available. The company's export data indicates a focus on medical devices and respiratory products, which may require FDA approvals for the US market. However, without publicly accessible records, it is challenging to assess the company's compliance with FDA regulations and its standing in the US market.

Appasamy Associates Private Limited's WHO prequalification status and EU Good Manufacturing Practice (GMP) certifications are not publicly disclosed. Obtaining WHO prequalification would enable the company to supply products to international markets, particularly in developing regions. EU GMP certification would facilitate access to the European market, ensuring compliance with stringent manufacturing standards. The company's export data suggests a focus on medical devices and respiratory products, which are subject to these certifications. However, without publicly available information, it is difficult to confirm the company's compliance with these international standards.

Appasamy Associates Private Limited holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority in India. The company's export data indicates compliance with Indian regulations for the production and export of medical devices and pharmaceutical products. Specific details regarding state drug controller approvals and export No Objection Certificates (NOCs) are not publicly available. The company's focus on medical devices and respiratory products suggests adherence to CDSCO guidelines and standards.

There are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Appasamy Associates Private Limited. The absence of such records suggests that the company maintains a compliant status with regulatory authorities. However, without detailed inspection histories, it is challenging to fully assess the company's regulatory standing.

Appasamy Associates Private Limited operates in the medical device and pharmaceutical sectors, focusing on products such as medical devices and respiratory medications. The company's export data indicates a concentration in these areas, with a total export value of $290,000 USD across 24 shipments. While specific competitors are not identified, the company's focus on medical devices and respiratory products suggests competition with other manufacturers in these therapeutic categories. A detailed market analysis is required to assess the company's position relative to competitors in overlapping categories and to understand market share dynamics.

Appasamy Associates Private Limited's key differentiators include its specialization in medical devices and respiratory products, as indicated by its export data. The company's focus on these therapeutic areas suggests expertise and a targeted approach to meeting market needs. However, without detailed information on product offerings, manufacturing capabilities, and certifications, it is challenging to identify specific competitive advantages.

Appasamy Associates Private Limited's strategic direction appears to focus on the manufacture and export of medical devices and respiratory products. The company's export data indicates a total export value of $290,000 USD across 24 shipments, with a concentration in Medical Devices & Diagnostics (63.0%) and Respiratory (37.0%) therapeutic categories. While the company is relatively new, having been incorporated in 2019, its strategic emphasis on these product areas suggests a commitment to addressing specific market needs. Further information is needed to assess the company's future outlook and potential for growth in these sectors.

Appasamy Associates Private Limited's export data indicates a total export value of $290,000 USD across 24 shipments, with a concentration in Medical Devices & Diagnostics (63.0%) and Respiratory (37.0%) therapeutic categories. The company's focus on these product areas suggests a targeted approach to meeting market demands. However, without detailed information on supplier relationships, manufacturing processes, and quality control measures, it is challenging to fully assess the company's track record, export volume consistency, and reliability.

Importers should verify the following certifications when considering products from Appasamy Associates Private Limited:

• FDA Approval: To ensure compliance with US regulations for medical devices and pharmaceutical products. Verification can be done through the FDA's official website or by contacting the company directly.

• WHO-GMP Certification: To confirm adherence to international manufacturing standards. Verification can be done through the World Health Organization's official website or by contacting the company directly.

• EU GMP Certification: To ensure compliance with European manufacturing standards. Verification can be done through the European Medicines Agency's official website or by contacting the company directly.

• ISO Certification: To confirm adherence to international quality management standards. Verification can be done through the International Organization for Standardization's official website or by contacting the company directly.

When conducting due diligence on Appasamy Associates Private Limited, consider the following steps:

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

• Assess Financial Health: Review the company's financial statements, including