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Advinus Therapeutics Ltd.

#21 & 22, Phase 2, Peenya Industrial Area

Bangalore, Karnataka 560058 IN

Certifications, Accreditations, Licenses:

  • GLP since 1992
  • Largest AAALAC certified animal vivarium in India, one of Asia's largest regulatory toxicology facilities
  • Submitted 35 complete IND packages (late lead optimization through IND) (11 with USFDA, 6 with TPP Health Canada, 6 with EMA, 2 with MHRA, 1 each with AEMPS Spain, HSA Singapore, Medsafe New Zealand, TGA Australia and NGCMA India), all of them getting FIH approvals without clinical hold
  • 7000 standalone Toxicology studies submitted to regulatory agencies worldwide
  • 56 Carcinogenicity studies including in RasH2 & p53 Transgenic mouse models
  • Robust historical control data from sub-chronic & chronic studies in rodents (including SD rats) & non-rodents available on Body weight & feed intake, Hematology and Clinical Chemistry, Histopathology, Tumor incidence, Teratology, Mutagenicity, etc.
  • 68 study directors including 6 DABTs, and over 110 scientists of whom 65% have either a Ph.D., M.S. (biology) or D.V.M degree including 25 trained histologists
  • Histopathology: Team of 5 Veterinary pathologists headed by a globally preeminent pathologist with >35 years of experience who has authored over 300 safety evaluation study reports including 28 carcinogenicity studies

**Important Note: This information has been provided by the Company and has not been confirmed by Contract Laboratory Inc. It is recommended that you confirm all information prior to using this company.

DISCLAIMER: This Laboratory Profile was provided by the company above.