Agog Pharma Limited

Agog Pharma Limited, established on December 20, 1990, is a public limited company headquartered in Mumbai, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U24230MH1990PLC059515. It operates in the pharmaceutical sector, specializing in the manufacturing of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The authorized and paid-up capital of Agog Pharma Limited is ₹3.15 crore.

As of January 10, 2026, Agog Pharma Limited employs 88 professionals. The company's leadership comprises three directors: Aziz Abdulhamid Damani, appointed on June 20, 2005; Shenaz Aziz Damani, appointed on June 2, 2006; and Anil Kumar Anirudh Pandey, appointed on September 30, 2005.

Agog Pharma Limited operates its manufacturing facility in Vasai, Mumbai, Maharashtra. The plant specializes in the production of various pharmaceutical dosage forms, including tablets, liquid orals, capsules, and dry syrup formulations. The facility is certified by WHO-GMP and ISO 9001:2000, ensuring adherence to international quality standards.

The leadership team at Agog Pharma Limited includes:

• Aziz Abdulhamid Damani: Director since June 20, 2005.

• Shenaz Aziz Damani: Director since June 2, 2006.

• Anil Kumar Anirudh Pandey: Whole-Time Director since September 30, 2005.

Agog Pharma Limited's export data indicates a significant presence in regulated markets, with a total export value of $5.0 million USD across 211 shipments. The company's top five exported products include Nystatin, Griseofulvin, Metronidazole, Quinine, and Captopril, with Nystatin leading as the top product. This suggests that Agog Pharma Limited has established a foothold in markets that require stringent regulatory compliance, such as the United States, European Union, United Kingdom, Australia, and Japan. However, specific regulatory filings, approvals, and market access statuses in these regions are not detailed in the available data.

Agog Pharma Limited's export data highlights a strong presence in emerging markets, with significant exports to regions in Africa, Latin America, and Southeast Asia. The company's adherence to WHO-GMP standards and ISO 9001:2000 certification facilitates access to these markets, as these certifications are often prerequisites for entry. The company's portfolio concentration, with the top five products accounting for 99.2% of exports, indicates a focused strategy that may enhance its competitiveness in these regions.

Agog Pharma Limited's export data reveals a diversified geographic strategy, with exports spanning multiple regions, including Africa, Latin America, and Southeast Asia. This diversification mitigates concentration risk and positions the company to leverage growth opportunities across different markets. The company's adherence to international quality standards, as evidenced by its WHO-GMP and ISO 9001:2000 certifications, supports its strategic direction in targeting both regulated and emerging markets.

Specific details regarding Agog Pharma Limited's FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not available in the provided data. However, the company's export data indicates a significant presence in markets that require stringent regulatory compliance, suggesting that Agog Pharma Limited may have engaged in the necessary regulatory processes to access these markets.

Agog Pharma Limited's manufacturing facility is certified by WHO-GMP and ISO 9001:2000, indicating compliance with international quality standards. While specific EU GMP certificates and EDQM status are not detailed in the available data, the company's adherence to WHO-GMP standards suggests a commitment to quality that aligns with EU GMP requirements.

Specific details regarding Agog Pharma Limited's CDSCO manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs) are not available in the provided data. However, the company's compliance with WHO-GMP and ISO 9001:2000 standards suggests adherence to Indian regulatory requirements.

The available data does not provide information on any Form 483 observations, warning letters, or import alerts associated with Agog Pharma Limited. The company's adherence to international quality standards, as evidenced by its WHO-GMP and ISO 9001:2000 certifications, suggests a proactive approach to regulatory compliance.

Agog Pharma Limited operates in a competitive pharmaceutical industry, with its top five products accounting for 99.2% of its export value. The company's focus on specific therapeutic categories, such as Advanced Antibiotics, Antifungals, and Advanced Antifungals, positions it against other manufacturers in these segments. While specific market share comparisons and head-to-head analyses are not available in the provided data, Agog Pharma Limited's adherence to international quality standards and its diversified geographic strategy may enhance its competitive position.

Agog Pharma Limited's key differentiators include its adherence to international quality standards, as evidenced by its WHO-GMP and ISO 9001:2000 certifications, and its diversified geographic strategy targeting both regulated and emerging markets. The company's focused product portfolio, with the top five products accounting for 99.2% of exports, indicates a strategic emphasis on specific therapeutic categories, potentially enhancing its expertise and market presence in these segments.

Agog Pharma Limited's current strategic direction appears to focus on manufacturing finished pharmaceutical formulations, with a product portfolio concentrated in specific therapeutic categories. The company's adherence to international quality standards and its diversified geographic strategy suggest a commitment to both regulated and emerging markets. Future strategic directions may involve expanding its product portfolio, enhancing regulatory approvals, and strengthening its presence in targeted markets to drive growth and competitiveness.

Agog Pharma Limited demonstrates a strong track record in the pharmaceutical industry, with a significant export value of $5.0 million USD across 211 shipments. The company's adherence to international quality standards, as evidenced by its WHO-GMP and ISO 9001:2000 certifications, indicates reliability and a commitment to quality. The focused product portfolio, with the top five products accounting for 99.2% of exports, suggests consistency in its offerings. However, specific indicators of reliability, such as customer feedback or supply chain performance metrics, are not available in the provided data.

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

• FDA Approval: Confirm the FDA approval status of specific products by checking the FDA's official website or contacting Agog Pharma Limited directly.

• WHO-GMP Certification: Verify the WHO-GMP certification by consulting the World Health Organization's official website or Agog Pharma Limited's certification documents.

• EU GMP Certification: Check the European Medicines Agency's (EMA) website or Agog Pharma Limited's certification documents for EU GMP certification details.

• ISO 9001:2000 Certification: Review Agog Pharma Limited's ISO 9001:2000 certification documents or consult the International Organization for Standardization's (ISO) website.

Importers should undertake the following steps to ensure due diligence:

• Verify Certifications: Confirm the validity of WHO-GMP, EU GMP, and ISO 9001:2000 certifications through official channels.

• Assess Regulatory Approvals: Ensure that products have the necessary approvals from relevant regulatory bodies, such as the FDA, CDSCO, and EMA.

• Evaluate Financial Stability: Review Agog Pharma Limited's financial statements to assess financial health and stability.

• Check Compliance History: Investigate any past regulatory actions, such as warning letters or import alerts, to assess compliance history.

• Conduct Site Audits: Perform on-site audits of manufacturing facilities to verify adherence to quality standards and regulatory requirements.

Red flags to watch for include expired certifications, unresolved regulatory issues, and inconsistent financial performance. Recommended pre-order checks involve verifying product approvals, assessing supply chain reliability, and ensuring compliance with import regulations.