Gaia Trade Private Limited

Gaia Trade Private Limited, established on 14 September 2012, is a private limited company based in Dabolim, Goa, India. The company is registered under the Corporate Identification Number (CIN) U51900GA2012PTC007044. Its authorized capital is ₹500,000, with a paid-up capital of ₹197,110. The registered office is located at Shop No.14, Ground Floor, Survey No.8/1, Umiya Quatro D, Commercia, Dabolim, Goa, 403801.

Gaia Trade Private Limited specializes in the wholesale and export of pharmaceutical products, focusing on finished pharmaceutical formulations such as tablets, capsules, syrups, and injections. The company operates under strict compliance with international regulatory frameworks, including the EU Good Distribution Practice (GDP) standards, ensuring the quality and safety of its products.

Gaia Trade Private Limited does not own manufacturing facilities; instead, it sources pharmaceutical products from manufacturers and authorized distributors. The company emphasizes compliance with international standards, including EU GDP, to ensure the quality and safety of its products.

The leadership team of Gaia Trade Private Limited comprises:

• Eran Niv: Managing Director since 14 September 2012.
• Ritu Sikka: Managing Director since 14 September 2012.
• Sanjay Balkrishna Salgaonker: Director since 28 December 2017.

Gaia Trade Private Limited's export activities are primarily focused on finished pharmaceutical formulations, including advanced diabetes medications such as Semaglutide, Empagliflozin, and Canagliflozin. The company's total export value is $504,000 USD, with 623 shipments across 3 products in 2 therapeutic categories. The top three products are:

• Semaglutide: $350,000 USD, Rank #4, 7.0% market share.
• Empagliflozin: $151,000 USD, Rank #11, 2.3% market share.
• Canagliflozin: $2,000 USD, Rank #14, 0.2% market share.

The primary therapeutic categories are Advanced Diabetes Medications (69.9%) and Diabetes & Endocrine (30.1%). The company's portfolio is highly concentrated, with the top three products accounting for 100% of the export value.

Gaia Trade Private Limited has a global reach, serving over 50 countries across multiple continents. The company specializes in providing high-quality, cost-effective medications sourced from India, catering to a diverse clientele that includes pharmacies, hospitals, clinics, NGOs, and insurers. By sourcing products from WHO-GMP, US FDA, and EU-GMP certified manufacturers, Gaia Trade ensures authenticity and adherence to international safety standards.

Gaia Trade Private Limited's export strategy is highly concentrated, with the top three products accounting for 100% of the export value. This indicates a focused approach in the Advanced Diabetes Medications and Diabetes & Endocrine therapeutic categories. While this concentration may offer specialized expertise, it also exposes the company to risks associated with market fluctuations and regulatory changes in these specific segments. Diversifying the product portfolio could mitigate such risks and open avenues in other therapeutic areas.

As of the latest available data, Gaia Trade Private Limited does not have FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), or Drug Master File (DMF) filings. The company primarily focuses on sourcing and exporting finished pharmaceutical formulations rather than manufacturing. Consequently, it does not have an FDA inspection history.

Gaia Trade Private Limited sources its pharmaceutical products from manufacturers and authorized distributors that are certified by the World Health Organization's Good Manufacturing Practice (WHO-GMP) and the European Union's Good Manufacturing Practice (EU GMP). This ensures that the products meet international quality and safety standards.

Gaia Trade Private Limited operates under the regulatory framework of the Central Drugs Standard Control Organisation (CDSCO) in India. The company holds the necessary licenses and approvals to engage in the wholesale and export of pharmaceutical products. Specific details regarding manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs) are not publicly disclosed.

There are no publicly available records of Form 483 observations, warning letters, or import alerts issued to Gaia Trade Private Limited. The company maintains a compliant status, adhering to international regulatory standards in its operations.

Gaia Trade Private Limited operates in a competitive pharmaceutical export market, focusing on finished pharmaceutical formulations in the diabetes and endocrine therapeutic categories. While specific competitors are not identified in the available data, the company's emphasis on compliance with international standards, such as EU GDP, and its sourcing from WHO-GMP, US FDA, and EU-GMP certified manufacturers position it favorably in the market. However, the high concentration of its product portfolio may limit its competitiveness in other therapeutic areas.

Gaia Trade Private Limited's key differentiators include its strict adherence to international regulatory frameworks, such as EU GDP, and its sourcing of products from certified manufacturers. The company's ability to handle flexible order quantities, from single vials to full pallets, and its specialization in serving small-to-medium organizations, including NGOs and humanitarian groups, further distinguish it in the market.

Gaia Trade Private Limited's current strategic direction focuses on the wholesale and export of finished pharmaceutical formulations, particularly in the diabetes and endocrine therapeutic categories. The company's emphasis on compliance and quality positions it as a reliable partner in global pharmaceutical trade. Future strategic initiatives may include diversifying the product portfolio to mitigate concentration risks and exploring new therapeutic areas to expand market reach.

Gaia Trade Private Limited demonstrates a strong track record in sourcing and exporting pharmaceutical products, with a total export value of $504,000 USD and 623 shipments across 3 products. The company's commitment to compliance with international standards and its sourcing from certified manufacturers indicate reliability and consistency in its operations. However, the high concentration of its product portfolio suggests a need for diversification to enhance long-term sustainability.

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

• FDA Approval: Confirm that the product is approved by the U.S. Food and Drug Administration.
• WHO-GMP Certification: Ensure the manufacturer holds a valid WHO-GMP certificate.
• EU GMP Certification: Verify the manufacturer's EU GMP certification.
• ISO Certification: Check for relevant ISO certifications related to quality management systems.

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

Importers should undertake the following steps to ensure a thorough due diligence process:

• Verify Certifications: Confirm all relevant certifications, including FDA, WHO-GMP, EU GMP, and ISO.
• Assess Financial Stability: Review the company's financial statements and credit history.
• Evaluate Product Quality: Request samples and conduct quality assessments.
• Check Regulatory Compliance: Ensure the company complies with all applicable regulations in the target market.
• Review References: Obtain and evaluate references from other clients or partners.

Red flags to watch for include expired or missing certifications, inconsistent financial records, and negative feedback from previous clients. Pre-order checks should include verifying the authenticity of certifications and assessing the company's ability to meet delivery timelines and quality standards.