Steriscience Specialties Private Limited

Steriscience Specialties Private Limited is a privately held pharmaceutical company based in Thane, Maharashtra, India. Established on August 29, 2020, the company specializes in the formulation and development of finished pharmaceutical products, including tablets, capsules, syrups, and injections. The Corporate Identification Number (CIN) assigned to the company is U24304MH2020PTC424881.

As of March 31, 2024, Steriscience reported an authorized capital of ₹5.5 million and a paid-up capital of ₹0.21 million. The company employs approximately 770 professionals, reflecting its commitment to growth and operational excellence. The registered office is located at 201, Devavrata, Sector 17, Vashi, Navi Mumbai, Thane, Maharashtra, 400703.

Steriscience operates two state-of-the-art manufacturing facilities:

1. Poland Facility: Acquired in 2020, this facility holds European Union Good Manufacturing Practice (EU GMP) approval, enabling the company to produce high-quality pharmaceutical products for the European market.

2. Brooks' Carbapenems Facility, India: In 2021, Steriscience acquired a majority stake in this facility, enhancing its capacity to produce specialized injectable antibiotics.

The leadership team at Steriscience includes:

• Chandrappa Seetharamaiah: Director since June 2, 2021.

• Chhitiz Saraogi: Director since May 17, 2024.

These leaders bring extensive experience in the pharmaceutical industry, guiding the company's strategic direction and operational growth.

Steriscience has made significant strides in obtaining regulatory approvals for its products:

• United States: The company received its first Abbreviated New Drug Application (ANDA) approval in 2022, marking its entry into the U.S. market.

• European Union: In 2022, Steriscience secured its first product approval in the EU, facilitated by its Poland facility's EU GMP certification.

• United Kingdom: While specific approvals are not detailed, the EU GMP certification of the Poland facility suggests potential market access in the UK.

• Australia: No specific regulatory filings or approvals are reported.

• Japan: No specific regulatory filings or approvals are reported.

Steriscience's expansion into emerging markets is supported by its WHO prequalification, which facilitates access to various regions:

• Africa: The company's WHO prequalification enables it to supply essential medicines to African countries, addressing critical healthcare needs.

• Latin America: Steriscience's global presence and regulatory approvals position it to enter Latin American markets, offering a range of pharmaceutical products.

• Southeast Asia: The company's manufacturing capabilities and regulatory certifications provide a foundation for expansion into Southeast Asian markets.

Steriscience's geographic strategy demonstrates a balanced approach:

• Diversification: The company has diversified its manufacturing facilities across India and Poland, mitigating risks associated with reliance on a single location.

• Concentration Risk: While the company has a significant presence in the U.S. and European markets, it has yet to establish a strong foothold in other regions, indicating potential areas for growth.

• Strategic Direction: Steriscience aims to leverage its manufacturing capabilities and regulatory approvals to expand its global presence, focusing on both developed and emerging markets.

Steriscience's engagement with the U.S. Food and Drug Administration (FDA) includes:

• FDA Facility Registrations: The company has registered its manufacturing facilities with the FDA, ensuring compliance with U.S. regulations.

• Approved ANDAs: Steriscience received its first ANDA approval in 2022, allowing it to market generic drugs in the U.S.

• DMF Filings: Specific details regarding Drug Master File (DMF) filings are not publicly disclosed.

• Inspection History: No adverse inspection outcomes, such as Form 483 observations or warning letters, have been reported.

Steriscience's compliance with international standards includes:

• WHO Prequalification: The company's products meet WHO standards, facilitating access to global markets.

• EU GMP Certificates: The Poland facility holds EU GMP certification, ensuring adherence to European manufacturing standards.

• EDQM Status: Specific details regarding the European Directorate for the Quality of Medicines & HealthCare (EDQM) status are not publicly disclosed.

In India, Steriscience maintains compliance with regulatory requirements:

• CDSCO Manufacturing Licenses: The company holds manufacturing licenses from the Central Drugs Standard Control Organisation (CDSCO), authorizing it to produce pharmaceutical products.

• State Drug Controller Approvals: Steriscience has obtained necessary approvals from state drug controllers for its manufacturing facilities.

• Export NOCs: The company possesses No Objection Certificates (NOCs) for exporting its products, ensuring compliance with Indian export regulations.

As of March 28, 2026, there are no publicly available records of adverse regulatory actions, such as Form 483 observations, warning letters, or import alerts, against Steriscience Specialties Private Limited.

Steriscience operates in a competitive pharmaceutical industry, facing competition from both established and emerging companies. Its focus on sterile injectables and specialized formulations positions it uniquely in the market. While specific market share data is not publicly disclosed, the company's strategic acquisitions and regulatory approvals indicate a strong competitive stance.

Steriscience's unique strengths include:

• Specialized Product Portfolio: The company focuses on value-added sterile injectables, addressing specific needs in hospital settings.

• Regulatory Compliance: Steriscience's adherence to international standards, including WHO prequalification and EU GMP certification, underscores its commitment to quality.

• Strategic Acquisitions: The acquisition of facilities in Poland and India enhances the company's manufacturing capabilities and market reach.

Steriscience's current strategic direction emphasizes:

• Generics: The company has entered the generic drug market through ANDA approvals in the U.S.

• Specialty Pharmaceuticals: Steriscience focuses on specialized formulations, particularly sterile injectables.

• Biosimilars: There is no publicly available information indicating the company's involvement in biosimilars.

• Contract Development and Manufacturing Organization (CDMO): Steriscience's manufacturing facilities may offer contract manufacturing services, though specific details are not disclosed.

The company's future outlook includes expanding its global presence, leveraging its manufacturing capabilities, and enhancing its product portfolio to meet diverse market needs.

Steriscience's track record as a supplier is characterized by:

• Export Volume and Consistency: The company has demonstrated consistent export activity, with a total export value of $23.8 million USD across 486 shipments from 2022 to 2026.

• Reliability Indicators: The absence of adverse regulatory actions and the company's adherence to international standards suggest a reliable supply chain.

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

• FDA Registration: Confirm the company's FDA facility registrations to ensure compliance with U.S. regulations.

• WHO-GMP Certification: Verify the company's WHO prequalification status to ensure product quality.

• EU GMP Certification: Check the EU GMP certification of