Services

Formulation

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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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