Bendamustine

Sold as Ribomustin, Bendamustine fresenius, Bendamustine mylan, Stinohet, Bendahet, Mianda, Baximo, Bendamustine adco, Spalbend, Bendamustine DRL, Ribend, Beduras, Milanda, Bendamustine accord, Bendaject

C₁₆H₂₁Cl₂N₃O₂358.30 g/mol

4-[5-[Bis(2-chloroethyl)amino]-1-methylbenzimidazol-2-yl]butanoic acid

Drag to rotate. Structure from PubChem CID 65628.

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Registration

Applicants: 11
Registrations: 26
Schedule source: Consolidated Schedules 06 July 2026

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Kiara Health (Pty) LtdCancelled	Ribomustin	25, 100	451127, 451128	S4	None
Fresenius Kabi South Africa (Pty) Ltd	Bendamustine fresenius	25 mg, 100 mg	500675, 500676	S4	None
Viatris Healthcare (Pty) Ltd	Bendamustine mylan	25mg, 100 mg	501062, 501063	S4	None
Hetero Drugs South Africa (Pty) Ltd	Stinohet, Bendahet	25, 100	510300, 510301, 512003, 512004	S4	None
Accord Healthcare (Pty) Ltd	Mianda, Milanda, Bendamustine accord	25	520433, 570197, 570198.197	S4	PI PIL
Adcock ingram limited2 of 4 cancelled	Baximo, Bendamustine adco	25 mg, 100 mg	530304, 530305, 530306.304, 530307.305	S4	None
Mc Pharma (Pty) Ltd	Spalbend	25, 100	550639, 550640	S4	None
Dr Reddyæs Laboratories (Pty) LtdCertificate held by Dr Reddy’s Laboratories (Pty) Ltd	Bendamustine DRL	180 mg	560216	S4	PI PIL
Innovata pharmaceuticals	Ribend	25, 100	560452, 560453	S4	None
Pharma-q Holdings (Pty) Ltd	Beduras	25 mg, 100 mg	561123, 561124	S4	PI PIL
Lamar International (Pty) Ltd	Bendaject	25 mg, 100 mg	570527, 570528	S4	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Ribomustin 25 EACH VIAL CONTAINS BENDAMUSTINHYDROCHLORID EQUIVALENT TO BENDAMUSTINE 25,0 mg	25	45112745/26/1127	Cancelled	S4	None
Ribomustin 100 EACH VIAL CONTAINS BENDAMUSTINHYDROCHLORID EQUIVALENT TO BENDAMUSTINE 100,0 mg	100	45112845/26/1128	Cancelled	S4	None
Bendamustine 25 MG fresenius EACH VIAL CONTAINS BENDAMUSTINE HYDROCHLORIDE 25, 0 mg	25 mg	50067550/26/0675	Registered	S4	None
Bendamustine 100 MG fresenius EACH VIAL CONTAINS BENDAMUSTINE HYDROCHLORIDE 100, 0 mg	100 mg	50067650/26/0676	Registered	S4	None
Bendamustine 25mg mylan EACH VIAL CONTAINS BENDAMUSTINE HYDROCHLORIDE 25,0 mg	25mg	50106250/26/1062	Registered	S4	None
Bendamustine 100 MG mylan EACH VIAL CONTAINS BENDAMUSTINE HYDROCHLORIDE 100,0 mg	100 mg	50106350/26/1063	Registered	S4	None
Stinohet 25 EACH 10 ml VIAL CONTAINS BENDAMUSTINE HYDROCHLORIDE EQUIVALENT TO BENDAMUSTINE 25,0 mg	25	51030051/26/0300	Registered	S4	None
Stinohet 100 EACH 10 ml VIAL CONTAINS: BENDAMUSTINE HYDROCHLORIDE EQUIVALENT TO BENDAMUSTINE 100,0 mg	100	51030151/26/0301	Registered	S4	None
Bendahet 25 EACH 10 ml VIAL CONTAINS BENDAMUSTINE HYDROCHLORIDE EQUIVALENT TO BENDAMUSTINE 25,0 mg	25	51200351/26/2003	Registered	S4	None
Bendahet 100 EACH 20 ml VIAL CONTAINS BENDAMUSTINE HYDROCHLORIDE EQUIVALENT TO BENDAMUSTINE 100,0 mg	100	51200451/26/2004	Registered	S4	None
Mianda 25	25Powder for concentrate for solution for infusion.	52043352/26/0433Approved 4 August 2020	Registered	S4	PI PIL
Baximo 25 MG EACH VIAL CONTAINS BENDAMUSTINE 25,0 mg	25 mg	53030453/26/0304	Registered	S4	None
Baximo 100 MG EACH VIAL CONTAINS: BENDAMUSTINE HYDROCHLORIDE MONOHYDRATE EQUIVALENT TO BENDAMUSTINE HYDROCHLORIDE 100,0 mg	100 mg	53030553/26/0305	Registered	S4	None
Bendamustine 25 MG adco EACH VIAL CONTAINS BENDAMUSTINE 25,0 mg	25 mg	530306.30453/26/0306.304	Cancelled	S4	None
Bendamustine 100 MG adco EACH VIAL CONTAINS BENDAMUSTINE 100,0 mg	100 mg	530307.30553/26/0307.305	Cancelled	S4	None
Spalbend 25 EACH VIAL CONTAINS: BENDAMUSTINE HYDROCHLORIDE 25,0 mg	25	55063955/26/0639	Registered	S4	None
Spalbend 100 EACH VIAL CONTAINS: BENDAMUSTINE HYDROCHLORIDE 100,0 mg	100	55064055/26/0640	Registered	S4	None
Bendamustine 180 mg/4 ML DRL BENDAMUSTINE HYDROCHLORIDE	180 mgConcentrate for solution for infusion	56021656/26/0216Approved 21 February 2023	Registered	S4	PI PIL
Ribend 25 EACH VIAL CONTAINS BENDAMUSTINE HYDROCHLORIDE 25,0 mg	25	56045256/26/0452	Registered	S4	None
Ribend 100 EACH VIAL CONTAINS BENDAMUSTINE HYDROCHLORIDE 100,0 mg	100	56045356/26/0453	Registered	S4	None
Beduras 25 MG Each vial contains: Bendamustine Hydrochloride 25,0 mg	25 mgPowder for concentrate for solution for infusion	56112356/26/1123Approved 12 August 2025	Registered	S4	PI PIL
Beduras 100 MG Each vial contains: Bendamustine Hydrochloride 100,0 mg	100 mgPowder for concentrate for solution for infusion	56112456/26/1124Approved 12 August 2025	Registered	S4	PI PIL
Milanda 25 solution for injection Each 1,0 ml Solution contains: Bendamustine Hydrochloride Monohydrate equivalent to Bendamustine Hydrochloride 25,0 mg	25Solution for injection	570197	Registered	S4	None
Bendamustine 25 solution for injection accord Each 1,0 ml Solution contains: Bendamustine Hydrochloride Monohydrate equivalent to Bendamustine Hydrochloride 25,0 mg	25Solution for injection	570198.19757/26/0198.197	Registered	S4	None
Bendaject 25 MG EACH VIAL CONTAINS: BENDAMUSTINE HYDROCHLORIDE 25,0 mg	25 mg	57052757/26/0527	Registered	S4	None
Bendaject 100 MG EACH VIAL CONTAINS: BENDAMUSTINE HYDROCHLORIDE 100,0 mg	100 mg	57052857/26/0528	Registered	S4	None

Regulatory status

Where S4 sits on the scale

S0S1S2S3S4S5S6S7S8

Prescription-only medicine.

Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.

Schedule S4, matched to the Consolidated Schedules by ingredient, confidence high.

Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.

Consolidated Schedules listings for Bendamustinhydrochlorid equivalent to bendamustine

S4: Bendamustine
Consolidated Schedules 06 July 2026, line 5457

Pharmacological class: Cytostatic agents (class 26)

This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.

SAHPRA documents

Professional information (PI)For healthcare professionalsMianda 25, Accord Healthcare (Pty) Ltd Patient information leaflet (PIL)For patients and carersMianda 25, Accord Healthcare (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Research articles

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