• slide
  • slide
  • slide
  • slide
  • slide
  • slide

Regulatory

Regulatory Filings in RnD studies
ANDA submissions: Five
NDA Approvals: Three

Manufacturing Facility (Sterile Onco Facility) Approvals:

  • Republic of Kenya Ministry of Medical Services Pharmacy and Poisons Board, KENYA
  • Food, Medicine and Health Care Administration and Control Authority, ETHIOPIA

Product Approvals:

  • Medicines and Medical Devices Agency Republic of MOLDOVA
  • Department of Health Food and Drug Administration of Philippines
  • Ministry of Health SRILANKA (SUWASIRIPAYA)
  • Drug Regulatory Authority, BHUTAN