General Injectables — Manufacturer & Supplier

Non-cytotoxic small-volume and large-volume parenterals — vials, ampoules, pre-filled syringes and lyophilised presentations.

The general injectable block runs non-cytotoxic sterile products across liquid vials, ampoules, pre-filled syringes and lyophilised vials, with terminal sterilisation wherever the monograph allows it and aseptic processing where it does not. Lines are qualified with media fills at the stated frequency, environmental monitoring runs continuously in Grade A and B areas, and every batch carries a complete executed batch record, deviation log and release data pack. Container closure integrity is tested by a validated physical method rather than dye ingress alone. Listed formulations describe manufacturing capability and qualified facility scope. They are not an offer of approved or marketed products, and any supply is subject to the customer holding the applicable marketing authorisation for the destination market.

Manufactured under the Stancor Pharma brand by Stancor Pharma.

Specifications

Presentations
1-50 ml vials, 1-20 ml ampoules, 0.5-10 ml pre-filled syringes, lyophilised vials
Therapy areas (capability)
Anti-infectives, analgesics, anaesthetics, steroids, electrolytes, vitamins and supportive care
Batch envelope
20 L to 1,500 L; 5,000 to 150,000 units per batch depending on presentation
Sterilisation
Terminal autoclave (F0 validated) or aseptic with 0.22 µm sterilising filtration and filter integrity testing
Environment
Grade A filling under Grade B background, continuous viable and non-viable monitoring
Documentation
Executed BMR, deviations, release data pack, CoA and CoC with every batch

General Injectables Applications

Applicable Standards & Specifications

Available Grades