Rusan Pharma Limited

Rusan Pharma Limited, established on March 15, 1994, is a privately held Indian pharmaceutical company specializing in the production of finished pharmaceutical formulations. The company is registered under the Corporate Identification Number (CIN) U24230MH1994PLC077069 and is headquartered at Rusan House, 58-D, Government Industrial Estate, Charkop, Kandivali (West), Mumbai, Maharashtra, India.

As of the latest available data, Rusan Pharma Limited has an authorized capital of ₹50 million and a paid-up capital of ₹48.41 million. The company is classified as a public unlisted entity and operates in the manufacturing sector, focusing on pharmaceuticals and medicinal chemicals.

The company's product portfolio includes a range of dosage forms such as tablets, capsules, syrups, and injections, catering to various therapeutic areas. Rusan Pharma Limited has established a strong presence in both domestic and international markets, emphasizing quality and compliance with international standards.

Rusan Pharma Limited operates multiple manufacturing facilities across India, each designed to meet specific production requirements and regulatory standards.

The Kandla Unit I in Gujarat specializes in the production of tablets, general capsules, sachets, injectables (lyophilized and liquid vials), glass ampoules, and cream & ointment formulations. This facility has received approvals from regulatory bodies in Brazil, South Africa, Tanzania, Zimbabwe, the UAE, Kenya, Uganda, Russia, Kazakhstan, and holds State-GMP and WHO-CDSCO certifications.

The Kandla Unit II, also in Gujarat, focuses on the manufacturing of transdermal patches, with an annual capacity of 6 million units. It is approved by authorities in Brazil, Australia, the UAE, and holds State-GMP and WHO-CDSCO certifications.

The Dehradun facility in Uttarakhand produces tablets, general capsules, oral liquids (syrups), transdermal patches, glass vials, and prefilled syringes. This plant has approvals from Canada, Europe, Australia, Brazil, South Africa, Ukraine, Kenya, Uganda, Switzerland, the UAE, Vietnam, and holds State-GMP and WHO-CDSCO certifications.

Additionally, Rusan Pharma Limited has API manufacturing facilities in Ankleshwar, Gujarat, and Pithampur, Madhya Pradesh. The Ankleshwar facility has an annual production capacity of 33 KL (33 tons) and is approved by the USFDA, Canada, Europe, Japan, Brazil, State-GMP, and WHO-CDSCO. The Pithampur facility, inaugurated in November 2023 with an investment of approximately ₹300 crore, focuses on the production of active pharmaceutical ingredients (APIs) for addiction treatment and pain management products.

Rusan Pharma Limited's leadership comprises individuals with extensive experience in the pharmaceutical industry. The company's board of directors includes:

• Navin Satyapal Saxena
• Balasaheb Annasaheb Patil
• Kunal Navin Saxena
• Ajay Ramasaran Saxena
• Sandeep Verma
• Aakarsh Navin Saxena

These directors play pivotal roles in steering the company's strategic direction and ensuring compliance with regulatory standards.

Rusan Pharma 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 facilities hold approvals from various regulatory bodies, facilitating market access in these regions.

In the United States, the Ankleshwar facility is approved by the USFDA, enabling Rusan Pharma Limited to supply products to the US market.

In Europe, the Dehradun facility has received approvals from European regulatory authorities, allowing the company to distribute its products across European countries.

The Australian market is accessible through approvals for the Kandla Unit II and Dehradun facilities, which are certified by the Therapeutic Goods Administration (TGA).

In Japan, the Ankleshwar facility holds approvals from Japanese regulatory authorities, facilitating market entry.

These regulatory approvals underscore Rusan Pharma Limited's commitment to maintaining high-quality standards and compliance with international regulations, thereby ensuring the safety and efficacy of its products in these markets.

Rusan Pharma Limited has strategically expanded its footprint into emerging markets, including regions in Africa, Latin America, and Southeast Asia. The company's manufacturing facilities have obtained approvals from various regulatory bodies in these regions, facilitating market access and distribution.

In Africa, the Kandla Unit I has received approvals from regulatory authorities in Kenya and Uganda, enabling the company to supply products to these markets.

In Latin America, the Dehradun facility holds approvals from Brazilian regulatory authorities, allowing Rusan Pharma Limited to distribute its products in Brazil.

In Southeast Asia, the Dehradun facility has obtained approvals from Vietnamese regulatory authorities, facilitating market access in Vietnam.

These approvals are indicative of Rusan Pharma Limited's commitment to meeting international quality standards and its proactive approach to expanding its presence in emerging markets.

Rusan Pharma Limited's geographic strategy reflects a balanced approach to market diversification and risk management. The company's manufacturing facilities are strategically located across India, each catering to specific regional and international markets.

The Kandla Unit I and II in Gujarat primarily serve markets in Africa, the Middle East, and parts of Europe, leveraging their proximity to key shipping routes. The Dehradun facility in Uttarakhand focuses on markets in Europe, Australia, and Southeast Asia, capitalizing on its certifications and approvals from various regulatory bodies. The Ankleshwar facility in Gujarat and the Pithampur facility in Madhya Pradesh are geared towards supplying APIs and finished formulations to regulated markets, including the United States, Europe, and Japan.

This strategic distribution of manufacturing capabilities across different regions allows Rusan Pharma Limited to mitigate concentration risks and respond effectively to market demands, thereby enhancing its global competitiveness.

Rusan Pharma Limited's Ankleshwar facility in Gujarat holds approvals from the US Food and Drug Administration (FDA), enabling the company to supply pharmaceutical products to the United States market.

The facility's compliance with FDA regulations underscores Rusan Pharma Limited's commitment to maintaining high-quality standards and ensuring the safety and efficacy of its products for the US market.

Rusan Pharma Limited's manufacturing facilities have obtained certifications from the World Health Organization (WHO) and the European Union Good Manufacturing Practice (EU GMP), reflecting the company's adherence to international quality standards.

These certifications are indicative of Rusan Pharma Limited's dedication to producing pharmaceutical products that meet global quality benchmarks, thereby ensuring the safety and efficacy of its offerings in international markets.

Rusan Pharma Limited's manufacturing facilities are approved by the Central Drugs Standard Control Organisation (CDSCO) and hold State-GMP certifications, ensuring compliance with Indian regulatory standards.

These approvals affirm the company's commitment to maintaining high-quality manufacturing practices and adhering to the regulatory requirements set forth by Indian authorities.

As of March 2026, there are no publicly available records indicating any Form 483 observations, warning letters, or import alerts issued to Rusan Pharma Limited by regulatory authorities. This absence suggests that the company maintains a strong compliance record with regulatory agencies.

Rusan Pharma Limited operates in a competitive landscape, with several key players in the pharmaceutical industry offering similar products in the analgesics, CNS & psychiatric, and advanced diabetes medications categories. The company's focus on de-addiction and pain management products differentiates it from competitors, allowing it to carve out a niche in these therapeutic areas.

While specific market share data for competitors is not available, Rusan Pharma Limited's strategic focus on specialized formulations positions it