Wilshire Technology, USA

OVERVIEW

Founded in 1997, a cGMP manufacturer of High Purity Low endotoxin grade excipients using advanced purification techniques.

  • FDA registered cGMP production facility.
  • Conforms to USP/ EP Pharma and Parenteral monographs.
  • Compliant to ICHQ7, 21 CFR-210-211 & IPEC
  • Inspected by FDA in April 2015; EMEA QP in April 2016, no critical observation in over 3 years.
  • Audited and approved by leading global Parenteral and Biologicals companies.
  • Lot sizes 50gm to 5000kg to fulfil customer’s specific requirements.
  • Total 90,000 square feet facility, including 8 small scale cGMP manufacturing suites.
  • ICH Q11 compliant process and product development.
  • DOE (Design of experiment) and QbD (Quality by Design) process approach.
  • High purity low endotoxin grade sugars, suitable for biopharmaceutical processing.

Products