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Manufacturing

Advanced manufacturing powered by cutting-edge technology, regulatory excellence, and uncompromising quality to deliver reliable pharmaceutical solutions worldwide.

Steriscience operator in full cleanroom gowning working at a sterile compounding vessel

Our Partnership Ethos: Integrity, Commitment & Transparency

At Steriscience, partnership is built on trust, transparency, and shared success. We believe in providing complete visibility across every stage of the product lifecycle, ensuring open communication, proactive collaboration, and informed decision-making.

Our agile project management approach enables us to respond swiftly to evolving needs while delivering the reliability, quality, and regulatory excellence of an experienced pharmaceutical manufacturing partner. By combining operational agility with deep technical expertise, we help navigate complexity, mitigate risks, and accelerate the path from development to commercialization—ensuring life-changing therapies reach patients faster.

100+

Process Validation
BatchesSince 2021

Our track record is the ultimate proof of our reliability. Since 2021, we have successfully executed over 100 Process Validation (PV) batches across all formats, proving our ability to transition products from development to commercial reality without missing a beat.

Sealed vials travelling along a Steriscience high-speed inspection and packing line
Rotary filling machine capping sterile vials on the Warsaw injectable line

Poland- Injectable Site (WARSAW)

Steriscience's Warsaw facility is a multi-format injectable manufacturing site serving regulated markets worldwide from its EU base. With a production capacity of approximately 70 million units across 14,000 sqm, it manufactures ampoules, pre-filled syringes, and liquid and lyophilized vials.

The site is among the few globally with dedicated ampoule manufacturing capability and also produces a first-of-its-kind 505(b)(2) vial product, highlighting its regulatory and technical expertise.

Approved by the US FDA, EU GMP, MHRA, TGA, Health Canada, and select Middle East regulators, the Warsaw facility is a trusted CMO partner for customers across Europe, North America, Australia, and the Middle East.

Cleanroom corridor inside the Brooks carbapenems manufacturing campus in Gujarat

BSL- Carbapenems Site (Brooks, Gujarat)

Steriscience's Brooks facility is a dedicated carbapenems manufacturing site with integrated capabilities spanning API to finished dosage forms. Set across a 66,000 sqm cGMP-compliant campus, the site operates two dedicated production lines with annual capacities of approximately 28 million units (DDP) and 1.2 million units (Lyo).

The facility manufactures a focused portfolio of carbapenem formulations and will soon enhance its supply chain through backward integration with a greenfield API unit, strengthening cost efficiency and supply reliability.

Approved by the US FDA, EU GMP, MHRA, Health Canada, and select LATAM and Middle East regulators, the site received its first ANDA approval in 2022 and is a trusted manufacturing partner for regulated carbapenem markets worldwide.

Delivering More Than Manufacturing

  • Uncompromising Integrity

    The highest ethical and quality standards in every batch we produce

  • Radical Transparency

    Full visibility throughout the project lifecycle

  • Agile Project Management

    Dedicated team aligned to your timelines

  • Collaborative Ownership

    An extension of your team, not just a vendor

  • Shared Mission

    Improving global patient access to critical care

  • Deep Technical Commitment

    30 years of heritage solving your toughest challenges