MALAYSIAN06AB03
Fluoxetine
Nervous System · Entry into the Malaysia market
Two clocks — the door and the route
The door is open, and your clock finishes before it changes — you'll make it through.
Door state: open · fill 1.5 new makers/yr · registration route ~18 months. The route completes while the door is still open. Verify the fill rate and route against current NPRA data before you rely on the timing.
Market gate — is the door open?
Door: Open
OpennessContestable · 48/100 — how contestable the market is, not whether you'll win
Makers7 registered makers on NPRA
Fill rate~1.5 new makers/yr registering (last 2 years)
Market sizeRM 5–10M · ≈ RM 5M 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 — 7 registration(s), mostly prescription