Manufacturing

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.

Steriscience's facility in Vadodara, Gujarat, India is a carbapenems site spanning API to finished dosage forms, and serves as a preferred partner to regulated markets across the US, EU, and rest of world. The site operates two dedicated capacity lines: up to ~28 million units annually on the DDP line, and up to ~1.2 million units annually on the Lyophilized line. Spanning a 66,000 sqm cGMP-compliant campus, the site manufactures carbapenem formulations across both DDP and Lyophilized capability, enabling flexible carbapenem manufacturing. The facility will further strengthen its supply chain through backward integration via the API unit, enhancing efficiency — a distinctive differentiator in the carbapenems injectable space. Approved by US FDA, EU GMP, MHRA, Health Canada, and select LATAM and Middle East regulators, and having received its first ANDA approval in 2022, the site combines regulatory depth with backward-integrated cost efficiency to serve as a trusted global partner for carbapenem supply.