MALAYSIAN06AX16
Venlafaxine
Nervous 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 3 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
OpennessContestable · 55/100 — how contestable the market is, not whether you'll win
Makers6 registered makers on NPRA
Fill rate~3 new makers/yr registering (last 2 years)
Market sizeRM 5–15M · ≈ RM 10M 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 — 6 registration(s), mostly prescription