MALAYSIAC10AA07
Rosuvastatin
Cardiovascular System · Entry into the Malaysia market
Two clocks — the door and the route
Wrong door — this one is a commodity floor: 29 makers already stand inside.
Door state: closed · 29 makers on the floor. A registration route lands you into a crowd, not a window. Look up-stack for a door that is still dated or still open.
Market gate — is the door open?
Door: Closed
OpennessTight · 43/100 — how contestable the market is, not whether you'll win
Makers29 registered makers on NPRA
Fill rate~16 new makers/yr registering (last 2 years)
Market sizeRM 110–320M · ≈ RM 215M midpoint
Our estimate — built from NHMS/MOH treated-patient counts against the MOH published price list, cross-checked against 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 — 29 registration(s), mostly prescription