NutriDiveNPRA
MAL13075057ACRZPrescription (MAL-A)

SUBOXONE FILM 2MG/0.5 MG

Generic Molecule: Buprenorphine Hydrochloride

ACTIVE & APPROVEDValid till: 27 Jul 2028
NPRA Official Regulatory Summary

SUBOXONE FILM 2MG/0.5 MG is a KKM-approved Prescription Medicine registered under MAL number MAL13075057ACRZ by ZUELLIG PHARMA SDN. BHD.. Its active ingredient is BUPRENORPHINE HYDROCHLORIDE 2.16mg, NALOXONE HYDROCHLORIDE 0.61mg, manufactured by Aquestive Therapeutics Inc.

Holder (PRH)
ZUELLIG PHARMA SDN. BHD.
Manufacturer
Aquestive Therapeutics Inc
First Registered
27 Jul 2023
Validity
27 Jul 2028

Prescription Required (Schedule Poison)

Need a valid doctor's prescription renewal in Malaysia?

Consult Online Doctor (Telehealth)

Active Ingredients & Strength Formulation

2 Components
Active Substance / MoleculeDeclared Strength / DosageGeneric Directory
BUPRENORPHINE HYDROCHLORIDE2.16mgFind Brands
NALOXONE HYDROCHLORIDE0.61mgFind Brands
Dosage values indicate declared active concentration per unit dose as registered with NPRA Malaysia.

Equivalent Registered Brands in Malaysia5 Available

Products sharing identical active ingredient formulation (Buprenorphine Hydrochloride) approved by NPRA.

View All 5 Brands
Prescription (MAL-A)MAL11095004AZ

Desud Plus 8mg/2mg Sublingual Tablets

Strength: 8.624mg
Medicell Pharmaceutical(malaysia) Sdn.bhd
NPRA Valid
Prescription (MAL-A)MAL23026005ACRSZ

Suboxone Film 2mg/0.5mg

Strength: 2.16 mg
ZUELLIG PHARMA SDN. BHD.
NPRA Valid
Prescription (MAL-A)MAL13075058ACRZ

SUBOXONE FILM 8MG/2MG

Strength: 8.64mg
ZUELLIG PHARMA SDN. BHD.
NPRA Valid
Prescription (MAL-A)MAL15065042AZ

BUPREN 8MG/2MG SUBLINGUAL TABLET

Strength: 8.640mg 0
PAHANG PHARMACY SDN. BHD.
CONDITIONAL REGISTRATION
Prescription (MAL-A)MAL15065041AZ

BUPREN 2MG/0.5MG SUBLINGUAL TABLET

Strength: 2.160mg 0
PAHANG PHARMACY SDN. BHD.
CONDITIONAL REGISTRATION

Malaysian KKM Security Hologram Verification

FarmaChecker & Meditag™

By Malaysian Ministry of Health (KKM) regulation, all genuine registered pharmaceuticals, health supplements (MAL-N), and traditional products (MAL-T) distributed in Malaysia must feature an official tamper-evident security hologram sticker on the physical packaging.

1. Visual Tilt Check

Tilt the box under light to view the micro-engraved KKM coat of arms and multi-layer iridescent security patterns.

2. Match MAL Number

Ensure the printed MAL code matches MAL13075057ACRZ exactly on label and box.

3. FarmaChecker Scan

Scan using the official FarmaChecker app on iOS / Android to authenticate serial token with NPRA servers.

If the packaging lacks a security hologram or fails the FarmaChecker scan, do not consume and report to Cawangan Penguatkuasaan Farmasi (CPF KKM).
Frequently Asked Questions & Verification Details

Is SUBOXONE FILM 2MG/0.5 MG approved by KKM / NPRA?

Yes. SUBOXONE FILM 2MG/0.5 MG is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL13075057ACRZ with current status PRODUCT APPROVED. Registration was filed by ZUELLIG PHARMA SDN. BHD..

What are the active ingredients of SUBOXONE FILM 2MG/0.5 MG?

The declared active therapeutic components are: BUPRENORPHINE HYDROCHLORIDE 2.16mg, NALOXONE HYDROCHLORIDE 0.61mg. Always follow dosage recommendations prescribed by a certified doctor or licensed pharmacist.

What are the registered generic alternatives in Malaysia?

In Malaysia, there are 6 registered brand formulations containing identical active ingredients (Buprenorphine Hydrochloride). You can review them in the alternative brands section above or consult your community pharmacist for generic bioequivalent substitution.

Semakan status pendaftaran KKM / NPRA: SUBOXONE FILM 2MG/0.5 MG (MAL13075057ACRZ) | Pengganti ubat di Malaysia | Bahan aktif ubat & maklumat farmasi.