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.
