Apotex Research Private Limited

Apotex Research Private Limited, incorporated on June 16, 2003, is a private unlisted company based in Bangalore, Karnataka, India. The company is registered under the Corporate Identification Number (CIN) U73100KA2003PTC032103. Its authorized capital stands at ₹460 crore, with a paid-up capital of ₹291.86 crore. The registered office is located at Site No.1, Bommasandra Industrial Area, 4th Phase, Jigani Link Road, Jigani Hobli, Karnataka 562158.

Apotex Research Private Limited specializes in the research and development of pharmaceutical formulations, focusing on finished dosage forms such as tablets, capsules, syrups, and injections. The company has a significant presence in the Indian pharmaceutical export market, with a total export value of $56.3 million USD and 1,280 shipments across 12 products in four therapeutic categories. The top five products include Apixaban ($18.1 million, 10.0% market share), Rosuvastatin ($7.8 million, 1.7% market share), Atorvastatin ($6.2 million, 0.6% market share), Amino ($4.1 million, 1.3% market share), and Acetaminophen ($3.7 million, 1.6% market share).

Apotex Research Private Limited operates a manufacturing facility located in Bommasandra Industrial Area, Jigani Hobli, Karnataka. The plant specializes in the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. While specific production capacities are not publicly disclosed, the facility is equipped to handle large-scale manufacturing to meet both domestic and international demand. The plant adheres to Good Manufacturing Practices (GMP) to ensure the quality and safety of its products.

The leadership team at Apotex Research Private Limited comprises experienced professionals:

• Goutam Vilas Pujari: Director
• Brian McClelland George: Director
• Yoganjaneya Reddy Panem: Director
• Kajal Palan: Director
• Indrajyoti Bose: Director

These individuals bring a wealth of expertise in pharmaceutical research, development, and manufacturing, contributing to the company's strategic direction and operational success.

Apotex Research Private Limited has established a presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company has filed Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) for various products, indicating a commitment to meeting stringent regulatory standards. However, in August 2018, the FDA issued a warning letter to Apotex Research Private Limited, citing violations of Current Good Manufacturing Practice (CGMP) regulations. The FDA recommended engaging a qualified consultant to assist in meeting CGMP requirements.

In the European Union, Apotex Research Private Limited has obtained marketing authorizations for several products, facilitating market access across member states. The company has also secured approvals from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom and the Therapeutic Goods Administration (TGA) in Australia, enabling the distribution of its products in these regions. In Japan, Apotex Research Private Limited has engaged in regulatory filings, though specific approval statuses are not publicly disclosed.

Apotex Research Private Limited has expanded its footprint into emerging markets, including regions in Africa, Latin America, and Southeast Asia. The company has pursued World Health Organization (WHO) prequalification for certain products, which is a critical step for gaining access to these markets. WHO prequalification ensures that products meet international standards of quality, safety, and efficacy, facilitating procurement by United Nations agencies and other international organizations. This strategic move enhances the company's ability to serve a broader patient population in developing regions.

Apotex Research Private Limited demonstrates a diversified geographic strategy by exporting to multiple regions, including the United States, European Union, United Kingdom, Australia, Japan, Africa, Latin America, and Southeast Asia. This approach mitigates concentration risk and leverages growth opportunities across different markets. The company's focus on obtaining regulatory approvals and WHO prequalification underscores its commitment to meeting international standards and expanding its global presence. Strategically, Apotex Research Private Limited aims to strengthen its position in both developed and emerging markets, aligning with its long-term growth objectives.

Apotex Research Private Limited has registered its manufacturing facility with the U.S. Food and Drug Administration (FDA), enabling the export of its pharmaceutical products to the United States. The company has filed Abbreviated New Drug Applications (ANDAs) for various products, indicating a proactive approach to entering the U.S. market. However, in August 2018, the FDA issued a warning letter to Apotex Research Private Limited, citing violations of Current Good Manufacturing Practice (CGMP) regulations. The FDA recommended engaging a qualified consultant to assist in meeting CGMP requirements.

Apotex Research Private Limited has obtained Good Manufacturing Practice (GMP) certifications from the World Health Organization (WHO) and the European Union (EU). These certifications validate the company's adherence to international standards in pharmaceutical manufacturing, ensuring the quality and safety of its products. The EU GMP certification facilitates market access across European Union member states, while WHO GMP certification is essential for supplying products to international organizations and emerging markets.

In India, Apotex Research Private Limited holds manufacturing licenses issued by the Central Drugs Standard Control Organisation (CDSCO), authorizing the production of pharmaceutical formulations. The company has obtained approvals from state drug controllers, enabling the distribution of its products within the domestic market. Additionally, Apotex Research Private Limited has secured export No Objection Certificates (NOCs), facilitating the export of its products to various international markets. These regulatory approvals demonstrate the company's compliance with Indian pharmaceutical regulations and its commitment to maintaining high manufacturing standards.

In August 2018, the U.S. Food and Drug Administration (FDA) issued a warning letter to Apotex Research Private Limited, citing violations of Current Good Manufacturing Practice (CGMP) regulations. The FDA recommended engaging a qualified consultant to assist in meeting CGMP requirements.

Apotex Research Private Limited operates in a competitive landscape, with several key players in the pharmaceutical industry offering similar products. The company's top five products—Apixaban, Rosuvastatin, Atorvastatin, Amino, and Acetaminophen—compete with offerings from other generic pharmaceutical manufacturers. Market share data indicates that Apotex Research Private Limited holds a 10.0% share in Apixaban, a 1.7% share in Rosuvastatin, a 0.6% share in Atorvastatin, a 1.3% share in Amino, and a 1.6% share in Acetaminophen. These figures suggest that while the company has a presence in these therapeutic categories, it faces competition from other manufacturers with larger market shares.

Apotex Research Private Limited's key differentiators include its focus on high-quality, affordable pharmaceutical formulations and its commitment to obtaining international regulatory approvals. The company's product portfolio spans multiple therapeutic categories, including cardiovascular, analgesics and antipyretics, and central nervous system (CNS) and psychiatric disorders. This diversification allows the company to address a broad spectrum of patient needs. Additionally, Apotex Research Private Limited's adherence to Good Manufacturing Practices (GMP) and its pursuit of WHO prequalification and EU GMP certifications underscore its dedication to maintaining high manufacturing standards.

Apotex Research Private Limited's current strategic direction focuses on expanding its presence in both developed and emerging markets through the export of generic pharmaceutical formulations. The company's efforts to obtain regulatory approvals from agencies such as the FDA, WHO, and EU highlight its commitment to meeting international standards and enhancing market access. Looking ahead, Apotex Research Private Limited aims to strengthen its position in the global pharmaceutical market by leveraging its manufacturing capabilities, regulatory compliance, and diverse product portfolio.

Apotex Research Private Limited has demonstrated a consistent track record in pharmaceutical manufacturing, with a total export value of $56.3 million USD and 1,280 shipments across 12 products. The company's adherence to Good Manufacturing Practices (GMP) and pursuit of international certifications, such as WHO prequalification and EU GMP, indicate a commitment to quality