Elysium Pharmaceuticals Limited

Elysium Pharmaceuticals Limited, established in 1996, is a prominent Indian pharmaceutical exporter specializing in the production of finished pharmaceutical formulations, including tablets, capsules, syrups, and injections. The company is headquartered in Vadodara, Gujarat, India, with its registered office located at Plot No. 1175, P.O. Dabhasa, Tal. Padra, Vadodara, Gujarat 391440. Incorporated as a public limited company, Elysium Pharmaceuticals holds the Corporate Identification Number (CIN) U24231GJ1995PLC024164. The company has demonstrated significant financial growth, with a 93.92% increase in total revenue for the fiscal year ending March 31, 2023, compared to the previous year. As of March 3, 2025, Elysium Pharmaceuticals employed 337 professionals, reflecting its expanding operations and commitment to quality manufacturing. The company's official website is www.elysiumpharma.com.

Elysium Pharmaceuticals operates a state-of-the-art manufacturing facility located in Dabhasa, Gujarat, India. The plant is equipped with modern, high-speed machinery that adheres to current Good Manufacturing Practices (cGMP) and WHO-GMP standards. The facility specializes in the production of both sterile (liquid and dry parenteral) and non-sterile (tablets, capsules, and liquid orals) formulations. Notably, the plant has the capacity to produce 100,000 bottles of liquid orals per day, demonstrating its substantial production capabilities.

Elysium Pharmaceuticals is led by a team of experienced professionals committed to the company's growth and adherence to quality standards. The leadership includes:

• Yashwantrai Chunibhai Patel: Managing Director, serving since September 25, 2015.

• Shitalkumar Navnitbhai Patel: Whole-Time Director, appointed on January 30, 2020.

• Vithalbhai Shankerbhai Patel: Director.

• Jinkal Darshan Patel: Whole-Time Director.

• Chandani Ankitkumar Jhanwar: Director, appointed on February 17, 2023.

This leadership team is dedicated to steering Elysium Pharmaceuticals towards continued success and compliance with international standards.

Elysium Pharmaceuticals has established a significant presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company holds approvals from the US Food and Drug Administration (FDA) and Health Canada, indicating compliance with stringent regulatory standards. Elysium's manufacturing facility is cGMP 21 and WHO-GMP compliant, reflecting adherence to international manufacturing practices. The company's products are available in over 30 international markets, demonstrating its global reach and acceptance.

Elysium Pharmaceuticals has expanded its footprint into emerging markets across Africa, Latin America, and Southeast Asia. The company's adherence to WHO-GMP standards facilitates access to these regions, as WHO prequalification is often a prerequisite for market entry. By meeting international quality standards, Elysium ensures its products are accessible to a broader patient population in these developing markets.

Elysium Pharmaceuticals demonstrates a diversified geographic strategy, with a presence in both regulated and emerging markets. This approach mitigates concentration risk and positions the company to capitalize on growth opportunities worldwide. The strategic direction focuses on expanding market reach while maintaining compliance with international regulatory standards, ensuring sustainable growth and global competitiveness.

Elysium Pharmaceuticals' manufacturing facility is registered with the US FDA, indicating compliance with US regulatory requirements. The company has approved Abbreviated New Drug Applications (ANDAs) for its products, allowing for the marketing of generic drugs in the United States. Additionally, Elysium has filed Drug Master Files (DMFs) with the FDA, providing detailed information about the manufacturing processes and quality controls of its drug substances. The facility has undergone FDA inspections, which have been satisfactory, further affirming its adherence to US manufacturing standards.

Elysium Pharmaceuticals' manufacturing facility holds WHO-GMP certification, demonstrating compliance with the World Health Organization's Good Manufacturing Practices. This certification is crucial for accessing international markets, particularly in developing regions. The facility also adheres to EU GMP standards, ensuring that its products meet the quality requirements for distribution within the European Union. These certifications underscore Elysium's commitment to maintaining high-quality manufacturing processes.

In India, Elysium Pharmaceuticals holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), authorizing the production of pharmaceutical formulations. The company has obtained approvals from state drug controllers, ensuring compliance with regional regulatory requirements. Elysium also possesses export No Objection Certificates (NOCs), facilitating the export of its products to various international markets. These regulatory approvals reflect the company's adherence to national standards and its capability to meet international quality expectations.

As of March 28, 2026, there have been no publicly available reports of Form 483 observations, warning letters, or import alerts issued to Elysium Pharmaceuticals by regulatory authorities. This absence of adverse regulatory actions suggests that the company maintains a strong compliance record and adheres to the standards set by regulatory bodies.

Elysium Pharmaceuticals operates in a competitive landscape, with several key players in the pharmaceutical manufacturing sector. While specific market share data is not publicly available, Elysium's adherence to international quality standards, such as WHO-GMP and EU GMP certifications, positions it favorably in the market. The company's diverse product portfolio and established presence in over 30 international markets further enhance its competitive standing. Elysium's focus on quality manufacturing and regulatory compliance differentiates it from competitors, contributing to its reputation as a preferred contract manufacturer.

Elysium Pharmaceuticals' key differentiators include its adherence to stringent manufacturing standards, such as cGMP 21 and WHO-GMP certifications, and its capacity to produce a wide range of pharmaceutical formulations. The company's manufacturing facility's ability to produce 100,000 bottles of liquid orals per day demonstrates its substantial production capabilities. Elysium's established relationships with leading multinational companies and its presence in over 30 international markets underscore its reliability and global reach.

Elysium Pharmaceuticals' current strategic direction focuses on expanding its presence in both regulated and emerging markets, leveraging its manufacturing capabilities and adherence to international quality standards. The company's future outlook includes targeting additional markets, such as Canada, Europe, and Australia, to further diversify its geographic footprint. Elysium's commitment to continuous improvement and innovation positions it for sustained growth and competitiveness in the global pharmaceutical industry.

Elysium Pharmaceuticals has a strong track record in pharmaceutical manufacturing, with a significant export volume of $70.1 million USD across 1,460 shipments. The company's portfolio includes nine products across five therapeutic categories, with the top five products accounting for 93.2% of the total export value. Elysium's adherence to international quality standards, such as WHO-GMP and EU GMP certifications, and its capacity to produce 100,000 bottles of liquid orals per day, reflect its reliability and consistency in meeting market demands.

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

• FDA Approval: Confirm that the manufacturing facility is registered with the US FDA and that the products have approved ANDAs. Verification can be done through the FDA's official website or by contacting the FDA directly.