Stericon Pharma Private Limited

Stericon Pharma Private Limited, established on July 10, 1990, is a privately held pharmaceutical company headquartered in Bangalore, Karnataka, India. The company is registered under the Corporate Identification Number (CIN) U33201KA1990PTC011056. As of the latest available data, Stericon Pharma has an authorized share capital of ₹47.5 million and a paid-up capital of ₹43.7 million. The company is classified as a non-government entity and operates in the manufacturing sector, specifically in the production of medical and optical instruments.

In the fiscal year ending March 31, 2024, Stericon Pharma reported a net sales revenue growth of 24.51%, indicating a positive financial trajectory. The company's operating profit margin (ROS) improved by 10.81%, and the net profit margin increased by 8.14%, reflecting enhanced operational efficiency. The return on equity (ROE) stood at 5.97%, suggesting effective utilization of shareholder funds.

Stericon Pharma operates a state-of-the-art manufacturing facility located in the Bommasandra Industrial Area of Bangalore, Karnataka. The facility is ISO 13485 certified by DNV GL Presafe, Norway, ensuring compliance with international quality management standards for medical devices. Additionally, the company's contact lens cleaning solutions are CE certified, authorizing their marketing within the European Union. The manufacturing plant specializes in the production of sterile multipurpose contact lens cleaning solutions and sterile eye and nasal formulations.

As of March 2026, the board of directors of Stericon Pharma Private Limited comprises:

• Ajay Bhushanlal Khushu
• Chinmay Rajesh Vasa
• Amar Narendrabhai Shah

These directors are responsible for steering the company's strategic direction and ensuring adherence to regulatory standards.

Stericon Pharma's products are CE certified, allowing them to be marketed within the European Union. This certification indicates compliance with the European Medical Device Directive, facilitating access to EU markets. The company's contact lens cleaning solutions are also BRC (British Retail Consortium) certified by SGS, UK, enabling supply to UK retail chains through strategic alliances.

Stericon Pharma has expanded its presence to over 48 countries, including regions in Africa, Latin America, and Southeast Asia. The company's commitment to quality is demonstrated by its ISO 13485 certification and CE marking, which are recognized internationally and facilitate market access in these emerging regions.

Stericon Pharma's strategic focus on international markets, particularly in Europe and emerging economies, indicates a diversification strategy aimed at reducing dependence on any single market. The company's certifications and quality standards support this approach, mitigating concentration risks and positioning Stericon Pharma for sustained growth.

As of March 2026, there is no publicly available information indicating that Stericon Pharma has FDA facility registrations, approved Abbreviated New Drug Applications (ANDAs), Drug Master File (DMF) filings, or a history of FDA inspections. This suggests that the company may not currently market its products in the United States or has not pursued FDA approvals for its pharmaceutical formulations.

Stericon Pharma's manufacturing facility is ISO 13485 certified, ensuring compliance with international quality management standards for medical devices. The company's contact lens cleaning solutions are CE certified, authorizing their marketing within the European Union. However, there is no publicly available information confirming WHO prequalification or EU Good Manufacturing Practice (GMP) certificates for the company's pharmaceutical products.

Stericon Pharma holds an AYUSH license, allowing it to manufacture Ayurvedic, Yoga, Naturopathy, Unani, Siddha, and Homeopathy products. The company manufactures eye and nasal preparations for Himalaya Healthcare India under this license. Additionally, Stericon Pharma has drug licenses for more than 200 products and can apply for new licenses based on customer requirements.

As of March 2026, there is no publicly available information indicating any Form 483 observations, warning letters, or import alerts issued to Stericon Pharma by regulatory authorities. This absence suggests that the company maintains a compliant standing with regulatory bodies.

Stericon Pharma operates in the pharmaceutical manufacturing sector, specializing in sterile eye and nasal formulations. While specific competitors are not identified in the available data, the company's certifications, such as ISO 13485 and CE marking, position it favorably in the market. These certifications enable access to regulated markets and enhance the company's competitive edge.

Stericon Pharma's key differentiators include its ISO 13485 certification, CE marking, and BRC certification, which underscore its commitment to quality and compliance with international standards. The company's extensive experience in manufacturing sterile eye and nasal formulations, along with its capability to produce over 200 products, further distinguishes it in the market.

Stericon Pharma's strategic direction focuses on manufacturing sterile eye and nasal formulations, with a strong emphasis on quality and compliance. The company's certifications and international presence indicate a commitment to expanding its footprint in regulated markets. Future outlooks would benefit from pursuing additional certifications, such as WHO prequalification and EU GMP, to enhance market access and competitiveness.

Stericon Pharma demonstrates a strong track record in pharmaceutical manufacturing, with a portfolio of over 200 products and a commitment to quality as evidenced by its ISO 13485 and CE certifications. The company's ability to manufacture products for various international clients indicates reliability and consistency in its operations. However, the lack of FDA approvals and WHO prequalification may limit its appeal to certain markets.

Importers should verify the following certifications when considering Stericon Pharma as a supplier:

• ISO 13485 Certification: Confirms compliance with international quality management standards for medical devices. Verification can be done by requesting a copy of the certificate from Stericon Pharma.

• CE Marking: Indicates conformity with European Union regulations for medical devices. Importers can verify this by checking the CE mark on the product packaging or by requesting documentation from the company.

• BRC Certification: Demonstrates compliance with British Retail Consortium standards. Verification can be performed by obtaining a copy of the certificate from Stericon Pharma.

When conducting due diligence on Stericon Pharma, importers should consider the following steps:

• Verify Certifications: Ensure that the company holds valid ISO 13485, CE, and BRC certifications.

• Assess Regulatory Compliance: Confirm that the company complies with relevant regulatory requirements in target markets.

• Evaluate Financial Health: Review the company's financial statements to assess profitability and stability.

• Inspect Manufacturing Facilities: If possible, conduct an on-site inspection to evaluate manufacturing practices and quality control measures.

• Review Product Portfolio: Examine the range of products offered to ensure they meet market demands and quality standards.

Red flags to watch for include expired or lapsed certifications, unresolved regulatory issues, and inconsistent financial performance. Recommended pre-order checks involve verifying product quality through samples and assessing the company's capacity to meet order volumes and delivery timelines.