Caplin Steriles Limited

Caplin Steriles Limited, established on December 12, 2018, is a public limited company incorporated in Chennai, Tamil Nadu, India. It operates under the Corporate Identification Number (CIN) U24304TN2018PLC126270. The company is a subsidiary of Caplin Point Laboratories Limited, a prominent Indian pharmaceutical firm. Caplin Steriles specializes in the development and manufacturing of high-quality injectable and ophthalmic products tailored for regulated markets. The company's registered office is located at 3rd Floor, Ashvich Towers, No.3, Developed Plots Industrial Estates, Perungudi, Chennai, Tamil Nadu 600096, India.

As of March 2025, Caplin Steriles reported an authorized share capital of ₹190 crore and a paid-up capital of ₹179.96 crore. The company has demonstrated significant growth and expansion since its inception, reflecting its commitment to quality and innovation in the pharmaceutical sector.

Caplin Steriles operates a state-of-the-art manufacturing facility located in Gummidipoondi, Tamil Nadu, India. This facility is approved by the US FDA, EU-GMP, INVIMA, and WHO-GMP, underscoring its compliance with international quality standards. The plant specializes in the production of sterile injectables and ophthalmic dosage forms, with a dedicated area for formulation development, analytical development, and stability studies.

The manufacturing capacity is substantial, with current annual outputs of 100 million units for liquid and lyophilized vials, 1 million units for pre-filled syringes, and 1 million units for ophthalmic droppers. Future expansions aim to increase these capacities significantly, including the addition of pre-mix bags and peptide injections.

Caplin Steriles Limited is led by a team of experienced professionals committed to the company's growth and adherence to quality standards. The Board of Directors includes:

• Mr. C.C. Paarthipan – Chairman
• Mr. Partheeban Vivek Siddarth – Director
• Mr. Rengaraj Viswanathan – Director
• Mr. Prem Venkatachalam Pavoor – Nominee Director
• Mr. Komattu Chacko John – Director
• Mr. Sathya Narayanan – Chief Financial Officer
• Mr. Ketan Mahendra Patel – Nominee Director

These leaders bring a wealth of experience and strategic vision to Caplin Steriles, driving its mission to deliver high-quality pharmaceutical products to regulated markets.

Caplin Steriles has established a strong presence in several regulated markets, including the United States, European Union, United Kingdom, Australia, and Japan. The company's manufacturing facility in Gummidipoondi has received approvals from the US FDA, EU-GMP, INVIMA, and WHO-GMP, facilitating access to these markets.

In the United States, Caplin Steriles has been proactive in filing Abbreviated New Drug Applications (ANDAs) for its products. For instance, in June 2023, the company received US FDA approval for its ANDA for Cisatracurium Besylate Injection USP, a nondepolarizing skeletal neuromuscular blocker.

The company's commitment to quality and regulatory compliance is further demonstrated by the successful completion of multiple US FDA audits, including an unannounced inspection conducted between August 5th and 9th, 2024, which concluded with zero observations.

Caplin Steriles has strategically expanded its footprint in emerging markets, particularly in Africa, Latin America, and Southeast Asia. The company's manufacturing facility in Suthukeny, Puducherry, India, is approved by INVIMA and WHO-GMP, enabling access to these regions.

The company's focus on emerging markets aligns with its mission to provide high-quality, affordable healthcare solutions to underserved populations. By leveraging its manufacturing capabilities and regulatory approvals, Caplin Steriles is well-positioned to meet the growing demand for pharmaceutical products in these regions.

Caplin Steriles has adopted a strategic approach to geographic diversification, focusing on both developed and emerging markets. The company's manufacturing facilities are approved by multiple international regulatory bodies, including the US FDA, EU-GMP, INVIMA, and WHO-GMP, facilitating access to a broad range of markets.

This diversification strategy mitigates concentration risk and positions Caplin Steriles to capitalize on growth opportunities across different regions. The company's commitment to quality and regulatory compliance further strengthens its strategic position in the global pharmaceutical market.

Caplin Steriles has demonstrated a strong commitment to meeting the stringent requirements of the US FDA. The company's manufacturing facility in Gummidipoondi, Tamil Nadu, India, has undergone multiple US FDA inspections, including an unannounced inspection conducted between August 5th and 9th, 2024, which concluded with zero observations.

The company has also been proactive in filing ANDAs for its products. In June 2023, Caplin Steriles received US FDA approval for its ANDA for Cisatracurium Besylate Injection USP, a nondepolarizing skeletal neuromuscular blocker.

Caplin Steriles' manufacturing facility in Suthukeny, Puducherry, India, holds approvals from WHO-GMP and EU-GMP, reflecting the company's adherence to international quality standards.

These certifications enable Caplin Steriles to supply pharmaceutical products to markets that require compliance with WHO and EU Good Manufacturing Practices, thereby expanding its global reach.

Caplin Steriles operates under the regulatory oversight of the Central Drugs Standard Control Organisation (CDSCO) in India. The company's manufacturing facility in Gummidipoondi, Tamil Nadu, is approved by the CDSCO, ensuring compliance with national pharmaceutical manufacturing standards.

The company's adherence to CDSCO regulations underscores its commitment to maintaining high-quality manufacturing practices and regulatory compliance within India.

Caplin Steriles has maintained a strong regulatory compliance record. Notably, an unannounced US FDA inspection conducted between August 5th and 9th, 2024, at the company's manufacturing facility in Gummidipoondi, Tamil Nadu, concluded with zero observations, highlighting the company's commitment to quality and regulatory standards.

Caplin Steriles operates in a competitive landscape, with several key players in the injectable and ophthalmic pharmaceutical market. The company's focus on high-quality products and adherence to international regulatory standards position it favorably against competitors. However, specific market share comparisons and head-to-head analyses are not available in the provided data.

Caplin Steriles distinguishes itself through its commitment to quality, innovation, and timely availability of medicines. The company's manufacturing facilities are approved by multiple international regulatory bodies, including the US FDA, EU-GMP, INVIMA, and WHO-GMP, facilitating access to a broad range of markets.

Additionally, Caplin Steriles has been proactive in expanding its product portfolio, with plans to launch over 20 products in the next twelve months, demonstrating its dedication to meeting diverse healthcare needs.

Caplin Steriles is strategically positioned as an R&D-driven company focusing on the development and manufacturing of high-quality injectables and ophthalmic products for regulated markets. The company's manufacturing facilities are approved by multiple international regulatory bodies, including the US FDA, EU-GMP, INVIMA, and WHO-GMP, facilitating access to a broad range of markets.

The company's commitment to quality, innovation, and regulatory compliance underscores its strategic direction and positions it for sustained growth in the global pharmaceutical market.

Caplin Steriles has demonstrated a strong track record in manufacturing and exporting pharmaceutical products.