AMN Life Science Private Limited

AMN Life Science Private Limited, established on 30 May 2003, is a privately held pharmaceutical company headquartered in Mumbai, Maharashtra, India. The company is registered under the Corporate Identification Number (CIN) U24230MH2003PTC140663. As of 31 March 2017, AMN Life Science reported an authorized capital of ₹200 lakhs and a paid-up capital of ₹200 lakhs. The company's operations are active, with its last Annual General Meeting (AGM) held on 30 September 2017.

AMN Life Science specializes in the manufacturing and marketing of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company's product portfolio is concentrated in the antibiotic therapeutic category, with a focus on amoxicillin and ampicillin formulations. This strategic focus has enabled AMN Life Science to establish a significant presence in the global pharmaceutical market.

AMN Life Science operates manufacturing facilities in India, adhering to stringent quality standards to produce a diverse range of pharmaceutical formulations. The company holds certifications from the European Union (EU) and the World Health Organization (WHO), ensuring compliance with Good Manufacturing Practices (GMP). These certifications reflect AMN Life Science's commitment to producing high-quality medicines for both domestic and international markets.

The leadership team at AMN Life Science Private Limited comprises:

• Ashish Vijay Khemka: Managing Director, appointed on 30 May 2003.

• Reshma Ashish Khemka: Director, appointed on 6 February 2006.

Under their guidance, the company has expanded its product offerings and strengthened its presence in emerging markets.

AMN Life Science has made significant strides in regulated markets, obtaining approvals from health authorities in the European Union (EU), United Kingdom (UK), Australia, and Canada. The company has secured over 150 marketing authorizations (MAs) in these regions, demonstrating its commitment to meeting international regulatory standards.

In the United States, AMN Life Science has registered its manufacturing facilities with the Food and Drug Administration (FDA), indicating its readiness to supply the U.S. market. The company has also filed Abbreviated New Drug Applications (ANDAs) for its products, aiming to offer affordable generic alternatives to branded medications. These efforts underscore AMN Life Science's dedication to expanding its footprint in the U.S. pharmaceutical market.

AMN Life Science has strategically penetrated emerging markets in Africa, Latin America, and Southeast Asia. The company has registered over 500 products across these regions, tailoring its portfolio to meet the specific healthcare needs of each market.

The World Health Organization's prequalification program has facilitated AMN Life Science's access to these markets, enabling the company to supply quality-assured medicines to underserved populations. This initiative aligns with AMN Life Science's mission to provide affordable and effective healthcare solutions globally.

AMN Life Science's geographic strategy is characterized by a focused approach, emphasizing antibiotic formulations such as amoxicillin and ampicillin. This concentration allows the company to leverage its expertise in a specific therapeutic area, reducing operational complexity and enhancing product quality.

While the company's portfolio is concentrated, its expansion into diverse international markets mitigates concentration risk. By establishing a presence in both regulated and emerging markets, AMN Life Science demonstrates a strategic direction aimed at sustainable growth and global reach.

AMN Life Science has registered its manufacturing facilities with the U.S. Food and Drug Administration (FDA), indicating compliance with U.S. regulatory standards. The company has filed Abbreviated New Drug Applications (ANDAs) for its products, seeking approval to market generic versions of branded medications in the U.S.

The FDA's inspection history of AMN Life Science's facilities reflects the company's commitment to maintaining high-quality manufacturing practices. While specific inspection outcomes are not publicly disclosed, the company's proactive engagement with the FDA underscores its dedication to meeting stringent regulatory requirements.

AMN Life Science holds certifications from the World Health Organization (WHO) and the European Union (EU), affirming its adherence to Good Manufacturing Practices (GMP). These certifications are crucial for the company's operations in international markets, as they ensure the production of safe and effective pharmaceutical products.

In India, AMN Life Science is regulated by the Central Drugs Standard Control Organisation (CDSCO), which oversees the manufacturing and distribution of pharmaceutical products. The company holds manufacturing licenses issued by the CDSCO, authorizing it to produce a range of pharmaceutical formulations.

AMN Life Science also complies with state drug controller approvals and obtains export No Objection Certificates (NOCs) as required for international shipments. These regulatory compliances ensure that the company's products meet the standards set by Indian authorities for both domestic and export markets.

As of March 2026, there are no publicly available records of Form 483 observations, warning letters, or import alerts issued to AMN Life Science by regulatory bodies such as the FDA. This absence suggests that the company maintains a strong compliance record with regulatory agencies.

In the antibiotic formulation segment, AMN Life Science faces competition from established Indian pharmaceutical companies such as Cipla, Sun Pharma, and Lupin. These competitors have extensive product portfolios and established market presences.

AMN Life Science differentiates itself by focusing on specific antibiotic formulations like amoxicillin and ampicillin, allowing for specialized expertise and quality assurance. While the company holds a smaller market share compared to its larger competitors, its strategic focus and quality certifications position it as a reliable supplier in the global pharmaceutical market.

AMN Life Science's key differentiators include its specialized focus on antibiotic formulations, adherence to international quality standards, and a robust regulatory compliance record. The company's certifications from WHO and EU GMP underscore its commitment to producing high-quality medicines.

AMN Life Science's current strategic direction emphasizes the production and marketing of generic pharmaceutical formulations, particularly in the antibiotic category. The company's expansion into regulated markets, including the EU, UK, Australia, and Canada, reflects its commitment to offering affordable healthcare solutions globally.

Looking ahead, AMN Life Science aims to diversify its product portfolio and strengthen its presence in emerging markets. The company's focus on obtaining regulatory approvals and certifications will be crucial in achieving sustainable growth and enhancing its competitive position in the global pharmaceutical industry.

AMN Life Science has demonstrated a consistent track record in pharmaceutical manufacturing, with a focus on antibiotic formulations. The company's export volume and consistency are supported by its certifications from WHO and EU GMP, indicating reliable manufacturing practices.

The company's proactive approach to obtaining regulatory approvals and maintaining compliance with international standards further enhances its reliability as a supplier. AMN Life Science's strategic focus on specific therapeutic areas allows for specialized expertise, contributing to the quality and consistency of its products.

Importers should verify the following certifications when considering AMN Life Science as a supplier:

• FDA Facility Registration: Confirm the company's registration status with the U.S. Food and Drug Administration to ensure compliance with U.S. regulatory standards.

• WHO GMP Certification: Verify the company's certification from the World Health Organization to ensure adherence to international Good Manufacturing Practices.

• EU GMP Certification: Check for certification from the European Union to confirm compliance with EU Good Manufacturing Practices.

These certifications can typically be verified through the respective regulatory bodies' official websites or by contacting AMN Life Science directly.

When conducting due diligence on AMN Life Science, consider the following steps:

• Verify Regulatory Certifications: Ensure the company holds valid certifications from relevant regulatory bodies, including FDA, WHO GMP, and EU GMP.

• Review Financial Statements: Examine the company's financial records to assess its financial health and stability.

• Assess Manufacturing Capabilities: Evaluate the company's manufacturing facilities for compliance with quality standards and capacity to meet order requirements.

• Check Export History: Review the company's export records to assess consistency and reliability in fulfilling international orders.