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Zhunan Site has been approved by Taiwan FDA PIC/S GMDP Follow-up Inspection (Medicinal product/ Drug product)

2022.08.03 Zhunan Site has been approved by Taiwan FDA PIC/S GMDP Follow-up Inspection (Medicinal product/ Drug product)

Manufacturer’s licenses number: (AP)0455153
Is the manufacturer of medicinal products for human use that has been inspected with the following pharmaceutical dosage form(s):


1.Dosage form:
  • Sterile products (for general)
  Liquid dosage forms:Injections (aseptic preparation-small volume liquids)
  Solid dosage forms:freeze-dried powder (aseptic preparation)
  • Sterile products (for cytotoxics)
  Liquid dosage forms:Injections (aseptic preparation-small volume liquids)
  Solid dosage forms:freeze-dried powder (aseptic preparation)


2.Processes:
  • Manufacturing operation
  • Packaging operation
  • Laboratory operation
  • Distribution operation
3.GDP operations (DA0717)
  • Supplying (with cold chain)
  • Holding (with cold chain)