AXA Parenterals Limited

AXA Parenterals Limited, established on July 22, 2005, is a public unlisted company headquartered in Delhi, India. The company is registered under the Corporate Identification Number (CIN) U24232DL2005PLC148247. Its authorized capital stands at ₹7.5 crore, with a paid-up capital of ₹7.38 crore. AXA Parenterals specializes in the manufacturing and marketing of sterile parenteral preparations, life-saving medicines, and hospital products. The company's operations are active, and it has a significant presence in both domestic and international markets.

The registered office of AXA Parenterals Limited is located at 703-704, Pearls Best Height-2, Netaji Subhash Place, Pitampura, Delhi, 110034, India. The company operates under the Ministry of Corporate Affairs (MCA) and is classified as a non-government company limited by shares. AXA Parenterals has been actively involved in the pharmaceutical sector for over two decades, focusing on the production of high-quality parenteral formulations.

AXA Parenterals Limited operates a state-of-the-art manufacturing facility located in Roorkee, Uttarakhand, India. The plant is designed in accordance with US FDA and EU guidelines, ensuring compliance with stringent regulatory standards. The facility spans 145,000 square feet of land, with a constructed area of 280,000 square feet over two floors. This expansive setup enables the company to produce a wide range of sterile parenteral preparations, including large and small volume parenterals, infusions, ophthalmic preparations, respiratory products, and critical care medicines.

The manufacturing plant is equipped with advanced technology and adheres to Good Manufacturing Practices (GMP) to ensure the highest quality standards. The facility's design and operations are aligned with the requirements of regulated markets, reflecting AXA Parenterals' commitment to excellence in pharmaceutical manufacturing.

AXA Parenterals Limited is led by a team of experienced professionals committed to driving the company's growth and maintaining its reputation for quality. The key executives include:

• Manoj Agarwal: Co-founder and Director, appointed on August 16, 2005.

• Puneet Kansal: Director, appointed on October 10, 2005.

• Sumit Kumar Agarwal: Director, appointed on October 1, 2010.

• Ruchir Gupta: Director, appointed on October 1, 2010.

• Avinash Chander Kher: Director, appointed on November 1, 2016.

• Milap Kapoor: Director, appointed on November 1, 2016.

• Yasha Agarwal: Whole-time Director, appointed on January 1, 2023.

This leadership team brings a wealth of experience and expertise to AXA Parenterals, guiding the company towards continued success in the pharmaceutical industry.

AXA Parenterals Limited has established a significant presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company's manufacturing facility is accredited with WHO-GMP certification, ensuring compliance with international quality standards. Additionally, AXA Parenterals has applied for EU-GMP certification, demonstrating its commitment to meeting the stringent requirements of the European market.

The company's adherence to US FDA and EU guidelines reflects its dedication to producing high-quality pharmaceutical products suitable for these regulated markets. AXA Parenterals' focus on compliance with international standards positions it as a reliable supplier in these regions. The company's products are designed to meet the specific regulatory requirements of each market, ensuring safety and efficacy for patients worldwide.

AXA Parenterals Limited has expanded its reach into emerging markets, including Africa, Latin America, and Southeast Asia. The company's WHO-GMP accreditation facilitates access to these regions, as it meets the quality standards recognized by the World Health Organization. This accreditation enables AXA Parenterals to supply its products to countries that require WHO-GMP certification for pharmaceutical imports.

In Africa, AXA Parenterals has established a strong presence, supplying life-saving medicines and hospital products to various countries. In Latin America, the company has penetrated markets such as Brazil and Colombia, offering a range of pharmaceutical products. In Southeast Asia, AXA Parenterals has expanded its footprint in countries like Thailand, the Philippines, and Singapore, providing high-quality parenteral formulations. The company's commitment to quality and compliance with international standards has been instrumental in its success in these emerging markets.

AXA Parenterals Limited has adopted a strategic approach to geographic diversification, expanding its operations across various regions to mitigate risks associated with market concentration. The company's presence in regulated markets such as the US, EU, UK, Australia, and Japan, as well as emerging markets in Africa, Latin America, and Southeast Asia, reflects its commitment to global growth. This diversification strategy allows AXA Parenterals to leverage opportunities in different markets and reduce dependency on any single region.

By establishing a footprint in both developed and developing markets, AXA Parenterals demonstrates its adaptability and ability to meet diverse regulatory requirements. The company's focus on compliance with international standards, such as WHO-GMP accreditation, supports its strategic direction and enhances its competitiveness in the global pharmaceutical industry.

AXA Parenterals Limited's manufacturing facility is designed to comply with US FDA guidelines, reflecting the company's commitment to meeting the stringent requirements of the US market. The facility's adherence to these standards ensures that the company's products are suitable for export to the United States. While specific details regarding FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, and inspection history are not publicly available, the company's compliance with US FDA guidelines indicates a strong foundation for potential market access.

The company's focus on meeting US FDA standards positions it to explore opportunities in the US market, contingent upon obtaining the necessary regulatory approvals. AXA Parenterals' commitment to quality and compliance enhances its prospects for successful entry into the US pharmaceutical market.

AXA Parenterals Limited holds WHO-GMP accreditation, demonstrating its adherence to international quality standards recognized by the World Health Organization. The company has also applied for EU-GMP certification, indicating its commitment to meeting the stringent requirements of the European market. These certifications reflect AXA Parenterals' dedication to producing high-quality pharmaceutical products suitable for regulated markets.

The company's focus on obtaining and maintaining these certifications underscores its commitment to quality and regulatory compliance, which are essential for accessing and competing in international markets.

AXA Parenterals Limited operates under the regulatory framework of the Central Drugs Standard Control Organisation (CDSCO) in India. The company's manufacturing facility is designed to comply with CDSCO guidelines, ensuring that its products meet the quality standards required for domestic and international markets. Specific details regarding CDSCO manufacturing licenses, state drug controller approvals, and export No Objection Certificates (NOCs) are not publicly available.

The company's adherence to CDSCO regulations reflects its commitment to maintaining high-quality standards and ensuring the safety and efficacy of its pharmaceutical products. This compliance is crucial for the company's operations within India and for exporting products to other countries.

As of March 28, 2026, there are no publicly available records indicating any Form 483 observations, warning letters, or import alerts issued to AXA Parenterals Limited. The company's adherence to international standards, such as WHO-GMP accreditation, suggests a strong commitment to quality and regulatory compliance.

The absence of regulatory actions against the company reflects positively on its operational practices and