Manufacturing

Adaptive manufacturing capabilities developed in record time

We operate 4 production facilities across India & Poland from where we deliver injectable medicines to patients worldwide. With all four facilities approved by the US FDA and two with EU GMP accreditations, Steriscience currently commercializes its products in all significant global markets including North America, Europe, Latin America, and APAC. We are an integrated pharmaceutical company with a strong R&D team that has completed over 30 product developments in its first 18 months of operation and a highly experienced operations team running the four facilities. With a highly experienced team in place and capacities available across our sites, we have several long-standing contract manufacturing partnerships and are open to collaborate for new business opportunities.

POLAND – GENERAL INJECTABLES SITE

Located in Warsaw, Poland, this 14000 square meter facility comes with 2200 square meters of built-up production area and another 1000 square meters of warehouse capacity. Catering to key global markets with our portfolio, we are also a preferred CMO partner for supplying injectable medications locally in Europe. This EU GMP approved facility houses four production lines consisting of an ampoule line, a pre-filled syringe line, a high-speed liquid and a separate vial line with both liquid and lyophilization capabilities.

Facility Approvals – US FDA, EU GMP, Health Canada

AmpoulesPre-filled Syringe Liquid Vials Lyophilized vials

INDIA – CARBAPENEMS SITE

Steriscience acquired a majority stake in Brooks in 2021 gaining access to a dedicated Carbapenems facility located in Gujarat, India. Set up in the year 2015, the facility today has a 150 strong workforce and is situated on an area covering 66000 square meters with 11000 square meters of built-up areas covering production, quality control laboratories, warehouse, and administration blocks. Already catering to patients in key emerging markets including India, we received our first ANDA approval from this facility August 2022, and will be launching first set of products in the US and Europe markets.

Our supply chain for anti-infectives is further strengthened with recent investments in a greenfield API manufacturing unit at this facility, making Steriscience one of the few fully integrated players for Carbapenems globally, while ensuring cost competitiveness.

Facility Approvals – US FDA, EU GMP, ANVISA, CDSCO

Lyophilized vialsSterile Dry Powder vials and API

INDIA – GENERAL INJECTABLES

Located in Bengaluru, India, this state-of-the-art USFDA approved facility offers a wide range of parenteral drug products with over two decades of experience supplying to the US, Europe and Australia markets. Situated on an area covering 6500 square meters, the facility consists of a 300+ strong workforce with three production lines.

The site has industry-leading expertise in lyophilization techniques and tremendous experience in cycle-time optimization. The facility also hosts an autoinjector device line that allows us to offer patient-friendly drug delivery solutions with capacities to produce 16 million autoinjectors annually.

Facility Approvals – US FDA, TGA, Health Canada

Lyophilized vialsLiquid Vials (aseptic and terminal sterilized)Pre-filled SyringesAutoinjectors

INDIA – PENICILLINS

A US-FDA approved dedicated penicillin facility; the beta-lactam plant is situated on an area covering 3900 square meters in Bengaluru, India and caters to global markets including US, Australia & Brazil.

Supply chain disruptions highlight a key vulnerability for penicillin production worldwide, with increased manufacturing capability for these life-saving drugs becoming imperative for ensuring continued access. With cGMP compliant stringent controls in place to avoid cross-contamination, the facility consists of two sterile dry powder lines, with an annual capacity of 32 million units.

Facility Approvals – US FDA, TGA, ANVISA

Sterile Dry powder vials