Contacare Ophthalmics AND Diagnostics

Contacare Ophthalmics and Diagnostics, established in 1996, is a prominent Indian pharmaceutical exporter specializing in finished pharmaceutical formulations, particularly in the ophthalmic sector. The company is headquartered in Vadodara, Gujarat, India, with its manufacturing facilities located in Padra, Gujarat. Contacare operates as a 100% Export Oriented Unit (EOU), focusing on the production and export of ophthalmic products.

The company's ownership structure is not publicly disclosed. Contacare is registered under the Corporate Identification Number (CIN) 24AAACC6606P1ZJ, indicating its legal standing in India. While specific revenue figures are not publicly available, the company employs approximately 100 individuals, reflecting its scale and operational capacity.

Contacare's manufacturing facilities are situated in Padra, Gujarat, India. The company operates as a 100% Export Oriented Unit (EOU), focusing on the production and export of ophthalmic products. Specific details regarding the capacities and specializations of these facilities are not publicly disclosed.

The company's leadership includes Mr. Biswa Ranjan Pradhan, who serves as the Director. Other key executives, such as the CEO, CFO, and additional members of the leadership team, are not publicly disclosed.

Contacare has engaged in trade with the United States, as evidenced by shipments to companies like Beaver Visitec International Inc. in 2019. However, the company has faced regulatory challenges in the U.S. market. In August 2017, the FDA issued Import Alert 55-05, which applied to all aseptically processed drugs manufactured or shipped by Contacare, including Sodium Chloride ophthalmic solution. Additionally, in April 2019, the FDA issued a Warning Letter to Contacare, citing violations related to sterility assurance and quality control.

In the European Union, United Kingdom, Australia, and Japan, specific regulatory filings, approvals, and market access statuses for Contacare are not publicly available. The company's focus appears to be primarily on the U.S. market, with limited information regarding its presence in these regions.

Contacare's export activities have extended to regions such as South America, with shipments to countries like the United States and South American nations. However, specific details regarding the company's presence in Africa, Latin America, and Southeast Asia are not publicly disclosed. The company's focus on ophthalmic products suggests potential opportunities in emerging markets, but further information is limited.

Contacare's export data indicates a concentration in the U.S. market, with shipments to companies like Beaver Visitec International Inc. in 2019. The company's portfolio concentration, with its top five products accounting for 100% of exports, suggests a focused product strategy. However, the limited information on its presence in other regions indicates potential risks associated with geographic concentration. Diversifying into additional markets could mitigate these risks and provide growth opportunities.

Contacare's manufacturing facility in Padra, Gujarat, India, is registered with the FDA, as indicated by its Facility Establishment Identifier (FEI) number 3006217304. The company has faced regulatory challenges in the U.S. market, including an Import Alert issued by the FDA in August 2017, which applied to all aseptically processed drugs manufactured or shipped by Contacare. Additionally, in April 2019, the FDA issued a Warning Letter to Contacare, citing violations related to sterility assurance and quality control. These actions highlight the importance of addressing regulatory compliance to maintain market access.

Specific information regarding Contacare's compliance with WHO prequalification, EU GMP certificates, and EDQM status is not publicly available. The company's focus on the U.S. market and the limited availability of information suggest that it may not hold these certifications. Obtaining such certifications could enhance the company's credibility and facilitate entry into additional regulated markets.

Contacare operates under the regulatory oversight of the Central Drugs Standard Control Organisation (CDSCO) in India. The company's manufacturing facility in Padra, Gujarat, is registered with the FDA, indicating compliance with international standards. Specific details regarding CDSCO manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs) are not publicly disclosed.

In April 2019, the FDA issued a Warning Letter to Contacare, citing violations related to sterility assurance and quality control. In August 2017, the FDA issued Import Alert 55-05, which applied to all aseptically processed drugs manufactured or shipped by Contacare, including Sodium Chloride ophthalmic solution. These actions underscore the need for stringent quality control measures and adherence to regulatory standards.

Contacare operates in the ophthalmic pharmaceutical sector, competing with other manufacturers of contact lenses, intraocular lenses, and related diagnostic products. Specific market share data and a detailed head-to-head analysis are not publicly available. However, the company's focus on ophthalmic products positions it within a competitive market that includes both domestic and international players.

Contacare's specialization in ophthalmic products, including contact lenses and intraocular lenses, distinguishes it in the pharmaceutical export market. The company's commitment to precision and daily comfort for users reflects its focus on quality and patient satisfaction. However, the limited diversification in its product portfolio, with the top five products accounting for 100% of exports, suggests a need for broader product offerings to mitigate market risks.

Contacare's current strategic direction appears to be focused on the export of ophthalmic products, primarily to the U.S. market. The company's portfolio concentration indicates a specialized approach, but the limited diversification may expose it to market fluctuations. Future strategic initiatives could include obtaining WHO prequalification and EU GMP certifications to enhance credibility and facilitate entry into additional regulated markets.

Contacare has demonstrated a consistent export volume, with 398 shipments totaling $2.4 million USD. The company's focus on ophthalmic products and its specialization in this sector reflect a reliable track record in its niche market. However, the limited diversification in its product portfolio suggests a need for broader offerings to enhance reliability and reduce dependency on a narrow product range.

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

• FDA Registration: Confirm the facility's registration status with the FDA to ensure compliance with U.S. regulations.

• WHO-GMP Certification: Verify the company's adherence to World Health Organization Good Manufacturing Practices to ensure product quality and safety.

• EU GMP Certification: Ensure the company holds European Union Good Manufacturing Practices certification for access to European markets.

• ISO Certification: Check for International Organization for Standardization certifications to assess the company's commitment to quality management systems.

When conducting due diligence on Contacare Ophthalmics and Diagnostics, consider the following steps:

• Regulatory Compliance: Verify the company's compliance with FDA regulations, including registration status and adherence to GMP standards.

• Quality Control Records: Review quality control documentation to assess the company's commitment to product quality and safety.

• Product Portfolio Diversification: Evaluate the diversity of the company's product offerings to assess potential risks associated with portfolio concentration.

• Market Access: Confirm the company's ability to access target markets, including the U.S., EU, and other regions, through appropriate certifications and approvals.

• Financial Stability: Assess the company's financial health to ensure reliability as a supplier.

Red flags to watch for include unresolved regulatory issues, limited product diversification, and lack of necessary