Dapagliflozin, metformin
Sold as Synglutra, Dapagliflozin metformin cipla, Redifarg xr
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 2
- Registrations
- 11
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Cipla Medpro (Pty) Ltd | Synglutra, Dapagliflozin metformin cipla | 5/500, 5/1 000, 10/500, 10/1 000 | 530649, 530650, 530651, 530652, 530653.649, 530655.651, 530656.652 | Not determined | None |
| Dr Reddyæs Laboratories (Pty) Ltd | Redifarg xr | 5 mg/500 mg, 5 mg 000 mg /1, 10 mg/500 mg, 10 mg 000 mg /1 | 570885, 570886, 570887, 570888 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Synglutra 5/500 ECAH TABLET CONTAINS DAPAGLIFLOZIN PROPRANEDIOL EQUIVALENT TO DAPAGLIFLOZIN 5,0 mg METFORMIN HYDROCHLORIDE 500,0 mg | 5/500 | 53064953/21.2/0649 | Registered | Not determined | None |
| Synglutra 10/500 ECAH TABLET CONTAINS DAPAGLIFLOZIN PROPRANEDIOL EQUIVALENT TO DAPAGLIFLOZIN 5,0 mg METFORMIN HYDROCHLORIDE 1 000,0 mg | 10/500 | 53065053/21.2/0650 | Registered | Not determined | None |
| Synglutra 5/1 000 ECAH TABLET CONTAINS DAPAGLIFLOZIN PROPRANEDIOL EQUIVALENT TO DAPAGLIFLOZIN 10,0 mg METFORMIN HYDROCHLORIDE 500,0 mg | 5/1 000 | 53065153/21.2/0651 | Registered | Not determined | None |
| Synglutra 10/1 000 ECAH TABLET CONTAINS DAPAGLIFLOZIN PROPRANEDIOL EQUIVALENT TO DAPAGLIFLOZIN 10,0 mg METFORMIN HYDROCHLORIDE 1 000,0 mg | 10/1 000 | 53065253/21.2/0652 | Registered | Not determined | None |
| Dapagliflozin metformin cipla 5/500 ECAH TABLET CONTAINS DAPAGLIFLOZIN PROPRANEDIOL EQUIVALENT TO DAPAGLIFLOZIN 5,0 mg METFORMIN HYDROCHLORIDE 500,0 mg | 5/500 | 530653.64953/21.2/0653.649 | Registered | Not determined | None |
| Dapagliflozin metformin cipla 5/1 000 ECAH TABLET CONTAINS DAPAGLIFLOZIN PROPRANEDIOL EQUIVALENT TO DAPAGLIFLOZIN 10,0 mg METFORMIN HYDROCHLORIDE 500,0 mg | 5/1 000 | 530655.65153/21.2/0655.651 | Registered | Not determined | None |
| Dapagliflozin metformin cipla 10/1 000 ECAH TABLET CONTAINS DAPAGLIFLOZIN PROPRANEDIOL EQUIVALENT TO DAPAGLIFLOZIN 10,0 mg METFORMIN HYDROCHLORIDE 1 000,0 mg | 10/1 000 | 530656.65253/21.2/0656.652 | Registered | Not determined | None |
| Redifarg xr 5 mg/500 MG EACH TABLET CONTAINS: DAPAGLIFLOZIN 5,0 mg METFORMIN HYDROCHLORIDE 500,0 mg | 5 mg/500 mg | 57088557/21.2/0885 | Registered | Not determined | None |
| Redifarg xr 5 mg/1 000 MG EACH TABLET CONTAINS: DAPAGLIFLOZIN 5,0 mg METFORMIN HYDROCHLORIDE 1 000,0 mg | 5 mg 000 mg /1 | 57088657/21.2/0886 | Registered | Not determined | None |
| Redifarg xr 10 mg/500 MG EACH TABLET CONTAINS: DAPAGLIFLOZIN 10,0 mg ,METFORMIN HYDROCHLORIDE 500,0 mg | 10 mg/500 mg | 57088757/21.2/0887 | Registered | Not determined | None |
| Redifarg xr 10 mg/1 000 MG EACH TABLET CONTAINS: DAPAGLIFLOZIN 10,0 mg METFORMIN HYDROCHLORIDE 1 000,0 mg | 10 mg 000 mg /1 | 57088857/21.2/0888 | Registered | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
S4: Dapagliflozin
Consolidated Schedules 06 July 2026, line 5942
S3: Metformin
Consolidated Schedules 06 July 2026, line 3938
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
SAHPRA has not published a professional information or patient information leaflet for this product.