Wexford Laboratories Private Limited

Wexford Laboratories Private Limited, established on August 2, 2002, is a privately held pharmaceutical company headquartered in Tumkur, Karnataka, India. The company is registered under the Corporate Identification Number (CIN) U24231KA2002PTC030849. As of the latest available data, Wexford Laboratories has an authorized capital of ₹7.5 million and a paid-up capital of ₹7.22 million. The company employs approximately 151 professionals. Wexford Laboratories specializes in the manufacturing of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections, adhering to WHO-GMP standards.

Wexford Laboratories operates multiple manufacturing facilities in Tumkur, Karnataka, India. These facilities are dedicated to various pharmaceutical formulations, including general products, penicillin and cephalosporin oral solid dosage forms, and sterile formulations. The company emphasizes compliance with WHO-GMP standards across its manufacturing processes.

The leadership team at Wexford Laboratories includes:

• Bini Deepak: Director, appointed on November 4, 2002.

• Deepak Badrinarayan: Director, appointed on August 2, 2002.

These individuals have been instrumental in steering the company's strategic direction and operations.

Wexford Laboratories has established a significant presence in regulated markets, particularly in Latin America. The company exports a diverse range of pharmaceutical formulations, including tablets, capsules, topicals, liquid orals, dry syrups, ophthalmic solutions, and injectables. These products comply with WHO-GMP standards, facilitating market access in these regions.

Wexford Laboratories has expanded its reach into emerging markets, notably in Africa, Latin America, Southeast Asia, and other regions. The company's adherence to WHO-GMP standards has been pivotal in obtaining necessary regulatory approvals, thereby enhancing its market penetration in these areas.

Wexford Laboratories has strategically diversified its export markets, focusing on regions such as Latin America, Africa, and Southeast Asia. This diversification mitigates concentration risk and positions the company to leverage growth opportunities across various geographies. The company's adherence to WHO-GMP standards has been instrumental in facilitating market access and regulatory approvals in these regions.

As of the latest available data, Wexford Laboratories has not reported any FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), or Drug Master File (DMF) filings. There is no publicly available information regarding FDA inspections or compliance history for the company. This suggests that Wexford Laboratories may not currently have a direct presence in the U.S. market.

Wexford Laboratories manufactures pharmaceutical formulations in compliance with WHO-GMP standards. However, there is no publicly available information confirming the company's possession of WHO prequalification, EU GMP certificates, or EDQM status. This indicates that while the company adheres to WHO-GMP standards, it may not have obtained specific certifications from WHO or the European Directorate for the Quality of Medicines & HealthCare (EDQM).

Wexford Laboratories holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO) in India. The company has also obtained necessary approvals from state drug controllers and export No Objection Certificates (NOCs) to facilitate its export operations. These regulatory compliances ensure that the company's products meet the required standards for domestic and international markets.

As of the latest available data, there are no publicly reported FDA Form 483 observations, warning letters, or import alerts associated with Wexford Laboratories. This suggests that the company has maintained a clean regulatory record in its export markets.

Wexford Laboratories operates in a competitive pharmaceutical export market, with key competitors including established Indian pharmaceutical companies such as Sun Pharmaceutical Industries, Dr. Reddy's Laboratories, and Cipla. While specific market share data is not publicly available, Wexford Laboratories' focus on WHO-GMP compliant formulations and its strategic presence in emerging markets position it as a competitive player in the industry.

Wexford Laboratories' key differentiators include its adherence to WHO-GMP standards, a diverse product portfolio encompassing various pharmaceutical formulations, and a strategic focus on emerging markets. These factors enable the company to offer high-quality products and effectively meet the needs of its international clientele.

Wexford Laboratories is strategically positioned as a fully integrated pharmaceutical company, focusing on the export of generic and branded products. The company's adherence to WHO-GMP standards and its expansion into emerging markets underscore its commitment to quality and growth. Future outlooks suggest continued emphasis on market diversification and compliance with international regulatory standards to enhance global presence.

Wexford Laboratories has demonstrated a consistent track record in pharmaceutical manufacturing, with a diverse product portfolio and a strategic focus on emerging markets. The company's adherence to WHO-GMP standards and its expansion into various geographies indicate reliability and a commitment to quality. However, the lack of specific certifications such as WHO prequalification and EU GMP certificates may be a consideration for potential partners.

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

• WHO-GMP Certification: To ensure compliance with World Health Organization Good Manufacturing Practices.

• EU GMP Certification: To confirm adherence to European Union Good Manufacturing Practices.

• ISO Certifications: To assess the company's quality management systems.

Verification can be conducted by requesting copies of the certificates directly from the company or by consulting the respective regulatory bodies' official databases.

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

• Verify Regulatory Certifications: Confirm the validity of WHO-GMP, EU GMP, and ISO certifications.

• Assess Financial Health: Review the company's financial statements for profitability and stability.

• Evaluate Manufacturing Capabilities: Inspect manufacturing facilities for compliance with international standards.

• Review Export Records: Examine export volumes and consistency to assess reliability.

• Check Regulatory Compliance: Ensure adherence to CDSCO and other relevant regulatory bodies.

Red flags to watch for include discrepancies in certification validity, financial instability, and non-compliance with regulatory standards. Recommended pre-order checks involve obtaining third-party audits and consulting with industry experts.