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Bio B2BOrient Pharma Co., Ltd. 〉Contract Manufacturing /Development

Contract Manufacturing /Development

Orient Pharma is capable of formulation development, process improvement (e.g. scale up), phase I-III clinical development, Clinical Trial Materials & registration batch production, and commercial manufacturing in PIC/S GMP and US FDA inspected plant.

Benchmark pharmaceutical manufacturer
  • Orient Pharma's Yunlin Plant was built with the highest standards of manufacturing, packaging and supporting system.
  • The plant passed the GMP inspection by US FDA, the PIC/S GMP inspection by Taiwan FDA, and received “Accreditation Certificate of Foreign Drug Manufacturer” from Labour and Welfare (MHLW) in Japan.
  • The plant is equipped with facility of leading brands, e.g. Glatt, Fette, Servolift, etc.
    • Fluid Bed Dryer
      Film Coater
      High Speed Tablet Compression Machine
      High Shear Mixer
      Hot Melt Capsule Filling Machine
      Final Blender 
      Wet Milling Unit
      Quick Sieve Mill.....
  • To prevent contamination, plant design complies with international standards for air conditioning, purified water, compressed air, and maintenance systems.

Quality control for materials
  • Adopt Active Pharmaceutical Ingredients (API) with DMF (Drug Master File).
  • The information of excipients and packaging materials all passed strict inspection.
  • The raw materials are certified and used for controlling quality.

Ability to conduct multi-centered clinical trials
  • With well-experienced Clinical Research Team (>20 members), we can provide the service of multi-countries & multi-centered clinical trials for our global partners.
  • Certificated of “Medical Research Service Company” by Ministry of Economic Affairs .
  • Successful experiences of passing Taiwan DOH and Singapore HAS inspections (GCP Inspection).

Integrated regulation competency
  • Experiences of US FDA pre-IND meeting & IND 
  • Familiar with 505(b)(2) new drug regulations
  • US FDA drug certificates: 2
  • US FDA Paragraph Ⅳ acceptance : 1
Service procedure
Initial Contact -> Sign CDA -> Clients fill in CMO/CDMO Request Form  -> Orient Pharma provides quotation with timeline -> Sign Contract
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