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ROCHE (MALAYSIA) SDN. BHD.

Date updated: 2026-04-19

TOTAL PRODUCT APPROVED: 61

TOTAL CONDITIONAL REGISTRATION: 5

Holder
BIOLOGICS
#3
Ranks are based on product registered in particular category, doesn't reflect the market position
NEW CHEMICAL ENTITY
#22
Ranks are based on product registered in particular category, doesn't reflect the market position

Overview

Product Registered

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Categories

Type of Products

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Analysis

Product Manufacturer

Product count15
Product count12
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Product count9
Product count5
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Analysis

Product API

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Listing

Registered Product

Evrysdi Powder for oral solution 0.75 mg/mL
Product Reg. noMAL21086002ARZ
TypeNEW CHEMICAL ENTITY
Product HolderROCHE (MALAYSIA) SDN. BHD.
ManufacturerF.HOFFMANN-LA ROCHE LTD
ImporterROCHE (MALAYSIA) SDN. BHD.
Registration StatusPRODUCT APPROVED
ESBRIET HARD CAPSULES 267MG
Product Reg. noMAL16115027ACRZ
TypeNEW CHEMICAL ENTITY
Product HolderROCHE (MALAYSIA) SDN. BHD.
ManufacturerCatalent Pharma Solutions, LLC
ImporterROCHE (MALAYSIA) SDN. BHD.
Registration StatusPRODUCT APPROVED
HERCEPTIN VIAL 440MG POWDER FOR CONCENTRATE
Product Reg. noMAL20014475ARZ
TypeBIOLOGICS
Product HolderROCHE (MALAYSIA) SDN. BHD.
ManufacturerGENENTECH INC
ImporterROCHE (MALAYSIA) SDN. BHD.
Registration StatusPRODUCT APPROVED
ENSPRYNG 120 mg/1ml solution for injection in pre-filled syringe
Product Reg. noMAL22046009ACRZ
TypeBIOLOGICS
Product HolderROCHE (MALAYSIA) SDN. BHD.
ManufacturerF. HOFFMANN-LA ROCHE LTD
ImporterROCHE (MALAYSIA) SDN. BHD.
Registration StatusPRODUCT APPROVED
PHESGO Solution for Subcutaneous Injection 600mg/600mg/10mL
Product Reg. noMAL22056047ARZ
TypeBIOLOGICS
Product HolderROCHE (MALAYSIA) SDN. BHD.
ManufacturerF.HOFFMANN-LA ROCHE LTD
ImporterROCHE (MALAYSIA) SDN. BHD.
Registration StatusPRODUCT APPROVED
PHESGO Solution for Subcutaneous Injection 1200mg/600mg/15mL
Product Reg. noMAL22056048ARZ
TypeBIOLOGICS
Product HolderROCHE (MALAYSIA) SDN. BHD.
ManufacturerF.HOFFMANN-LA ROCHE LTD
ImporterROCHE (MALAYSIA) SDN. BHD.
Registration StatusPRODUCT APPROVED
RECORMON PRE-FILLED SYRINGES 2000IU/0.3ML
Product Reg. noMAL20020495ARZ
TypeBIOLOGICS
Product HolderROCHE (MALAYSIA) SDN. BHD.
ManufacturerROCHE DIAGNOSTICS GMBH
ImporterROCHE (MALAYSIA) SDN. BHD.
Registration StatusPRODUCT APPROVED
RECORMON PRE-FILLED SYRINGES 4000IU/0.3ML
Product Reg. noMAL20020496ARZ
TypeBIOLOGICS
Product HolderROCHE (MALAYSIA) SDN. BHD.
ManufacturerROCHE DIAGNOSTICS GMBH
ImporterROCHE (MALAYSIA) SDN. BHD.
Registration StatusPRODUCT APPROVED
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