Genex Pharma

Genex Pharma, established in 2007, is a reputable Indian pharmaceutical company specializing in the manufacturing and export of life-saving medicines. Headquartered in Goregaon (W), Mumbai, Maharashtra, the company operates with a strong presence in over 50 countries worldwide. Genex Pharma is committed to ethical operations and integrity across its global activities.

The company is privately held and operates as a partnership. As of the latest available data, Genex Pharma employs between 11 to 50 individuals. The Corporate Identification Number (CIN) is not publicly disclosed. While specific revenue figures are not publicly available, the company has demonstrated consistent growth and expansion in its export activities.

Genex Pharma operates WHO-GMP compliant manufacturing facilities, ensuring adherence to international quality standards. The company has a strong presence in over 50 countries worldwide, reflecting its commitment to global healthcare.

The leadership team at Genex Pharma comprises individuals with extensive experience in the pharmaceutical industry. Mr. Chirag Shah, with over two decades in the sector, serves as a key figure in the company's operations. Mr. Rajiv Shah brings 35 years of expertise, particularly in manufacturing and product development. Mr. Pranav Shah, with nearly four decades in marketing and administration, emphasizes ethical practices and regulatory compliance.

Genex Pharma's export portfolio includes products such as Protein, Nitroglycerin, Indomethacin, Temozolomide, and Digoxin, with significant market shares in various therapeutic categories. The company's adherence to WHO-GMP standards facilitates access to regulated markets, ensuring compliance with international quality and safety standards.

Genex Pharma's global presence extends to over 50 countries, indicating a strategic focus on emerging markets. The company's commitment to ethical operations and integrity supports its expansion into diverse regions, including Africa, Latin America, and Southeast Asia.

Genex Pharma's export activities are concentrated in specific therapeutic categories, with the top five products accounting for 88% of the total export value. This concentration suggests a strategic focus on high-demand products, potentially mitigating risks associated with a diversified portfolio. The company's expansion into over 50 countries reflects a deliberate geographic diversification strategy.

Specific details regarding Genex Pharma's FDA facility registrations, approved ANDAs, DMF filings, and inspection history are not publicly disclosed. The company's adherence to WHO-GMP standards indicates a commitment to quality, which is essential for FDA approvals.

Genex Pharma's manufacturing facilities are WHO-GMP compliant, ensuring adherence to international quality standards. While specific EU GMP certifications are not publicly disclosed, the company's commitment to quality suggests potential compliance with EU standards.

Genex Pharma operates under the regulations of the Central Drugs Standard Control Organisation (CDSCO) in India. Specific details regarding CDSCO manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs) are not publicly disclosed. The company's adherence to WHO-GMP standards indicates compliance with national regulatory requirements.

There are no publicly available records of Form 483 observations, warning letters, or import alerts associated with Genex Pharma. The company's adherence to WHO-GMP standards and ethical operations suggests a proactive approach to regulatory compliance.

Genex Pharma operates in a competitive landscape with numerous pharmaceutical companies offering similar products. The company's focus on high-demand products such as Protein, Nitroglycerin, Indomethacin, Temozolomide, and Digoxin, with significant market shares, positions it competitively in the market. The company's adherence to WHO-GMP standards and ethical operations further enhances its competitive standing.

Genex Pharma's key differentiators include its adherence to WHO-GMP standards, ensuring high-quality products, and its ethical operations and integrity across global activities. The company's focus on high-demand products with significant market shares demonstrates its strategic approach to product selection.

Genex Pharma's strategic direction focuses on manufacturing and exporting life-saving medicines across various therapeutic categories, including cardiovascular, oncology, hormonal-infertility, and anti-bacterials. The company's adherence to WHO-GMP standards and ethical operations supports its position in the generics and specialty pharmaceuticals sectors.

Genex Pharma's adherence to WHO-GMP standards and ethical operations indicates a reliable track record in manufacturing and exporting pharmaceutical products. The company's export volume and consistency, with a presence in over 50 countries, reflect its reliability in global markets.

Importers should verify the following certifications when considering Genex Pharma:

• WHO-GMP Certification: Ensures compliance with international quality standards.

• EU GMP Certification: Indicates adherence to European manufacturing standards.

• FDA Approval: Validates compliance with U.S. regulatory requirements.

• ISO Certification: Demonstrates commitment to quality management systems.

These certifications can typically be verified through the respective regulatory bodies' official websites or by contacting Genex Pharma directly.

When conducting due diligence on Genex Pharma, consider the following steps:

• Verify Certifications: Confirm WHO-GMP, EU GMP, FDA, and ISO certifications.

• Assess Regulatory Compliance: Review compliance with CDSCO and other relevant regulatory bodies.

• Evaluate Financial Health: Analyze financial statements and revenue trends.

• Review Product Portfolio: Examine the range and quality of products offered.

• Check Market Presence: Assess the company's presence in target markets.

Red flags to watch for include discrepancies in certification details, regulatory non-compliance, financial instability, and quality control issues. Recommended pre-order checks involve verifying product quality through samples, assessing supply chain reliability, and ensuring alignment with import regulations.