MAL14125081ACRZPrescription (MAL-A)

Janumet XR 100mg/1000mg (Sitagliptin phosphate/Metformin HCl extended-release) film-coated tablets

Generic Molecule: Metformin Hydrochloride

ACTIVE & APPROVEDValid till: 6 Dec 2029
NPRA Official Regulatory Summary

Janumet XR 100mg/1000mg (Sitagliptin phosphate/Metformin HCl extended-release) film-coated tablets is a KKM-approved Prescription Medicine registered under MAL number MAL14125081ACRZ by MERCK SHARP & DOHME (MALAYSIA) SDN. BHD.. Its active ingredient is METFORMIN HYDROCHLORIDE 1000mg, SITAGLIPTIN PHOSPHATE 128.5mg, manufactured by AIAC International Pharma, LLC.

Holder (PRH)
MERCK SHARP & DOHME (MALAYSIA) SDN. BHD.
Manufacturer
AIAC International Pharma, LLC
First Registered
6 Dec 2024
Validity
6 Dec 2029

Prescription Required (Schedule Poison)

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Active Ingredients & Strength Formulation

2 Components
Active Substance / MoleculeDeclared Strength / DosageGeneric Directory
METFORMIN HYDROCHLORIDE1000mgFind Brands
SITAGLIPTIN PHOSPHATE128.5mgFind Brands
Dosage values indicate declared active concentration per unit dose as registered with NPRA Malaysia.

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 MAL14125081ACRZ 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 Janumet XR 100mg/1000mg (Sitagliptin phosphate/Metformin HCl extended-release) film-coated tablets approved by KKM / NPRA?

Yes. Janumet XR 100mg/1000mg (Sitagliptin phosphate/Metformin HCl extended-release) film-coated tablets is actively registered with the National Pharmaceutical Regulatory Agency under official registration number MAL14125081ACRZ with current status PRODUCT APPROVED. Registration was filed by MERCK SHARP & DOHME (MALAYSIA) SDN. BHD..

What are the active ingredients of Janumet XR 100mg/1000mg (Sitagliptin phosphate/Metformin HCl extended-release) film-coated tablets?

The declared active therapeutic components are: METFORMIN HYDROCHLORIDE 1000mg, SITAGLIPTIN PHOSPHATE 128.5mg. Always follow dosage recommendations prescribed by a certified doctor or licensed pharmacist.

What are the registered generic alternatives in Malaysia?

In Malaysia, there are 51 registered brand formulations containing identical active ingredients (Metformin Hydrochloride). You can review them in the alternative brands section above or consult your community pharmacist for generic bioequivalent substitution.

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