ONCOLOGY DRUG PRODUCTS

CORDEN PHARMA LATINA S.p.A.

Drug Product manufacturing requires dedicated and specialized capabilities which are in compliance with FDA aseptic guidance and all other major regulatory agencies requirements, including EMA.

Corden Pharma Latina S.p.A. has a long track record of experience in manufacturing Parenteral Sterile Solutions & Lyophilized Powder in vials, liquid ampoules and Oral Solid Dosage (tablets & capsules). Our facility and equipment design, combined with experienced and trained personnel, are pivotal for success in both sterile and oral solid dose manufacturing.

Why Corden Pharma Latina S.p.A?

  • >> Flexible approach
  • >> Technology transfer expertise
  • >> Clinical & commercial manufacturing capabilities
  • >> Highly customizable packaging & serialization
  • >> Supplies more than 90 markets

Oncology Drug Products

Sterile Powder Lyophilized Vials

Oncology Drug Products

Sterile Liquids

Sterile Manufacturing

Corden Pharma Latina S.p.A. focuses on the manufacturing of complex Sterile Cytotoxic & Cytostatic Drug Products. Their scientific team of experts help overcome technical challenges, including process and formulation development, technology transfer and analytical method development. Corden Pharma Latina S.p.A. has extensive experience in the optimization of the freeze drying process, which represents a critical attribute for complex parenteral product development. Corden Pharma Latina S.p.A. excels at all phases in the development of solution and freeze-dried dosage forms, for both aqueous and organic solvent solutions.

Corden Pharma Latina S.p.A. is comprised of two separate segregated suites with three filling lines (two for vials and one for ampoules) and two compounding rooms equipped with fixed and portable vessels. The production is fully supported by a development group with analytical development and QA/QC functions. The facility is designed with appropriate controls, along with a containment culture that allows the safe manufacture of cytotoxic & cytostatic products.

Production Suite 1

  • >> 6 Dissolution Vessels with a capacity range from 50 to 1,150 L (glass-lined & stainless steel)
    • >> IMA (Farmomac) Vial Washer, Depyrogenation Tunnel, Filling & Capping
      • >> Production speed of approx. 150 vials / minute (20 R vial)
      • >> Vials: 5 to 102 ml with current tooling
      • >> Two Freeze Dryers 38m2 and 27m2 with 18 and 15 Shelves Respectively. Temperature range of -55 °C / +80 °C and SIP at every cycle
    • >> Ampule Filling Line
      • >> Bosch line
      • >> Ampule size 5 to 10 ml
      • >> Terminal sterilization

Production Suite 2

  • >> 2 Dissolution stations with the capability of compounding 30 L to 400 L
    • >> IMA Vial Washer, Depyrogenation Tunnel, Filling & Capping
      • >> Production speed of approx. 250 vials / minute (20 R vial)
      • >> Vials: 10 to 50 ml with current tooling
      • >> One freeze dryer 29m2 (15 shelves). Temperature range of -55 °C / +80 °C and SIP at every cycle

Oncology Drug Products

Oral Formulation Tablets & Capsules

Oral Solid Dosage

Processing Equipment

  • >> Granulation (Zanchetta Roto Wet 50 L and 600 L), Milling, Sieving
  • >> Blending (bin, v-blending Bohl, screw mixing PCE
  • >> Tableting (Manesty Betapress & Manesty Dry-cota)
  • >> Capsule (Bosch GKF 800 and 2500; Macofar MT20) with metal detector

Oncology Drug Products

Pharma Packaging & Logistics

Packaging

  • >> Vials & ampoules packaging lines
  • >> Bottle HDPE & Glass
  • >> Blisters
  • >> Customized manual packaging
  • >> Full serialization capabilities

Oncology Drug Products

Drug Product Support Services

Other Services

  • >> Stability studies
  • >> Cleanability
  • >> Process development & optimization
  • >> Regulatory support

Corden Pharma Latina S.p.A. been authorized by the main MoH Agencies (FDA, EMA, TGA, ANVISA, PMDA, MFDS, TFDA) to distribute products worldwide.

Integrated Supply

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.


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