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Introduction on business and technologies of Pharmaceutical Technology R&D Division

Pharmaceutical Technology R&D Division of SPERA PHARMA develops the formulation design that is highly value-added (speed, cost, differentiation, novelty of formulation) based on the technologies and experiences cultivated in R&D at leading Japanese pharmaceutical company. We are engaged in the pharmaceutical research and development which depends on the developing stages and the service for high quality & cost competitive manufacturing, the development of robust cost-effective manufacturing process considering the scaling up to production scales, and documentation for new drug application (CTD Modules 3)

Click on each item below for more details.

  • Oral formulation: Development & Manufacturing
    • Tablets, capsules
    • Pediatric formulation
    • Immediate Release (IR) formulation
    • Fixed Dose Combination (FDC) formulation
    • Oral Disintegrating Tablet (ODT) formulation
    • Modified Release (MR) formulation
    • Solubilized formulation for absorption enhancement
  • Sterile injection: Development & Manufacturing
    • Vials (Ampules)
    • Lyophilized formulation, solution / powder fillers
    • High dosing formulation
    • Device development
    • Solubilized formulation
  • Primary and secondary packaging: Design & Manufacturing
    • Moisture proof package
    • Light resistant package
    • CR-Package, blister card package, sachet
    • Environmentally friendly package
    • Innovative package (Desiccant-integrated Al blister)
  • Optimization of manufacturing process
    • Manufacturing based on Quality by Design
    • Manufacturing based on Process Analytical Technology
  • CTM manufacturing & supply
    • Agile manufacturing and supply for IND for oral drug products
    • Single-use system for sterile drug products
    • High-level containment control

Technologies and Achievements

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Inquiries About Service

SPERA provides CMC solutions from early-stage through new drug application.

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