STERILE SEGREGATED ANTIBIOTICS
Segregated Antibiotic APIs
Manufacture of segregated Beta-lactam antibiotics presents many challenges to the pharmaceutical industry. The requirement for dedicated facilities and the need for both non-sterile (oral) and sterile grade APIs offers a unique and infrastructure-intensive challenge.
Corden Pharma Latina S.p.A. provides customers with dedicated technologies for the production of both Oral & Sterile Segregated Antibiotic APIs through our experience with aseptic technique.
Our sterile manufacturing facilities are comprised of:
- >> Chemical Processing & Sterile Filtration
- >> Crystallisation
- >> Isolation
- >> Drying & Powder Treatment
- >> Blending with Sterile Excipients
We provide oral & sterile cephalosporins, oral & sterile penicillins, and oral grade monobactams, all of which are manufactured in isolated and dedicated manufacturing facilities with extensive vessel capacity and capability.
Sterilization, blending and milling services are also offered and all completed onsite.
Sterile Powder Fill Drug Products
Corden Pharma Latina S.p.A. has extensive commercial experience Filling Sterile Powder into vials via vacuum / pressure dosing filling machines for the worldwide market, specifically serving the Segregated Antibiotic arena. At Corden Pharma Latina S.p.A., facility and equipment design, combined with experienced and trained personnel, are pivotal for success in sterile manufacturing.
Our dedicated manufacturing lines comprise vial washing, depyrogenation tunnels, powder filling, capping, external vial washing, X-ray inspection and automatic unloading. All activities take place in appropriately classified, validated and monitored cGMP facilities to ensure aseptic processing.
Cephalosporin Manufacturing Line:
- >> IMA MD300 operating with Vial Sizes between 15 and 77 ml
- >> Production Speed of 40 vials / minute
- >> Batch Size of up to 135,000 vials
At Corden Pharma Latina S.p.A., the combination of Cephalosporin Manufacture, Sterile Crystallization and Sterile Powder Filling results in an integrated supply offering unrivaled in the pharmaceutical industry today. Combined with our industry-leading Serialization capabilities and extensive experience supplying Drug Products globally, Corden Pharma Latina S.p.A. translates your project into a successful, high-value product, regardless of whether you are at an advanced clinical stage or looking for competitive commercial product offerings.
Corden Pharma Latina S.p.A.’s ability to develop and manufacture Active Pharmaceutical Ingredients (APIs), Finished Dosage and Packaging in our network of facilities allows clients full access to integrated services resulting in a simplified supply chain, reduced risk and cost associated with technology transfers, and ultimately faster production and delivery timelines.