MALAYSIAC09CA01
Losartan
Cardiovascular System · Entry into the Malaysia market
Two clocks — the door and the route
The door is closing while your clock runs — you would register into a crowd, not an opening.
Door state: closing · fill 9 new makers/yr · registration route ~18 months. By the time the route completes, more makers have filled in. Verify the fill rate and route against current NPRA data before reading this as a stop.
Market gate — is the door open?
Door: Closing
OpennessTight · 43/100 — how contestable the market is, not whether you'll win
Makers14 registered makers on NPRA
Fill rate~9 new makers/yr registering (last 2 years)
Market sizeRM 10–25M · ≈ RM 20M midpoint
Our estimate — NHMS treated-patient counts × the MOH published price list, triangulated against MOH government procurement receipts and cross-checked on the NPRA registry. No licensed panel.
Pathway gate — can I get in, how, how long?
Abridged / generic evaluation
~12–18months
Bioequivalence study
PIC/S GMP certification
Local product registration holder
FeesRM5,000 processing + RM20,000 GMP inspection (foreign site)
NPRA DRGD 6th ed., generic evaluation timeline; PIC/S fees verified 2026-07directional estimate — verify
Basis — 14 registration(s), mostly prescription