Sufentanil
Sold as Pharma-q sufentanil, Pharma-q sufentanil forte, Mylan sufentanil, Sufenta, Sufenta forte
N-[4-(Methoxymethyl)-1-(2-thiophen-2-ylethyl)piperidin-4-yl]-N-phenylpropanamide
Drag to rotate. Structure from PubChem CID 41693.
Background
Registration
- Applicants
- 3
- Registrations
- 8
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharma-q Holdings (Pty) Ltd | Pharma-q sufentanil, Pharma-q sufentanil forte | 10 ug/2 ml, 50 ug/10 ml, 250 ug/5 ml | 330397, 330398, 330426 | S6 | None |
| Viatris South Africa (Pty) Ltd | Mylan sufentanil | 5 ug/ml 2 ml, 5ug/ml 10 ml | 410625, 410626 | S6 | None |
| Piramal Critical Care South Africa (Pty) LtdCertificate held by Piramal Critical Care (Pty) Ltd | Sufenta, Sufenta forte | 2 ml, 10 ml, 50 µg | T0240, T0241, V0308 | S6 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharma-q sufentanil injection 10 ug/2 ML EACH 2,0 ml SOLUTION CONTAINS SUFENTANIL 10,0 ug | 10 ug/2 mlInjection | 33039733/2.7/0397 | Registered | S6 | None |
| Pharma-q sufentanil injection 50 ug/10 ML EACH 10,0 ml SOLUTION CONTAINS SUFENTANIL 50,0 ug | 50 ug/10 mlInjection | 33039833/2.7/0398 | Registered | S6 | None |
| Pharma-q sufentanil forte injection 250 ug/5 ML EACH 5,0 ml SOLUTION CONTAINS SUFENTANIL CITRATE EQUIVALENT TO SUFENTANIL 250,0 ug | 250 ug/5 mlInjection | 33042633/2.7/0426 | Registered | S6 | None |
| Mylan sufentanil 5 ug/ml 2 ML EACH 1,0 ml SOLUTION CONTAINS SUFENTANIL CITRATE EQUIVALENT TO SUFENTANIL 5,0 ug | 5 ug/ml 2 ml | 41062541/2.9/0625 | Registered | S6 | None |
| Mylan sufentanil 5ug/ml 10 ML EACH 1,0 ml SOLUTION CONTAINS:SUFENTANIL CITRATE EQUIVALENT TO SUFENTANIL 5,0 ug | 5ug/ml 10 ml | 41062641/2.9/0626 | Registered | S6 | None |
| Sufenta 2 ML EACH 1 ml CONTAINS SUFENTANIL CITRATE 0,0075 mg EQUIVALENT TO SUFENTANIL BASE 0,005 mg | 2 ml | T0240T/2.9/0240 | Registered | S6 | None |
| Sufenta 10 ML EACH 1 ml CONTAINS SUFENTANIL CITRATE 0,0075 mg EQUIVALENT TO 0,005 mg SUFENTANIL BASE | 10 ml | T0241T/2.9/0241 | Registered | S6 | None |
| Sufenta forte EACH 1 ml CONTAINS SUFENTANIL CITRATE EQUIVALENT TO 50 mcg SUFENTANIL | 50 µgSolution for injection or infusion | V0308V/2.9/308Approved 6 November 2020 | Registered | S6 | PIPIL |
Regulatory status
Where S6 sits on the scale
Prescription-only, no repeats without a new prescription.
Schedule 6 covers the most tightly controlled ordinary prescription medicines. Every dispensing needs its own new prescription; nothing can be repeated on the same script. When prescribed, the quantity must be written out in both figures and words. 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 S6, 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.
Consolidated Schedules listings for Sufentanil
S6: Sufentanil
Consolidated Schedules 06 July 2026, line 10427
Pharmacological class: Antipyretics or antipyretic and anti-inflammatory analgesics. (class 2.7)
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
Schedule Verification
Sufenta forte, Piramal Critical Care South Africa (Pty) Ltd is scheduled S6 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.