AfricaRegulatory
African Pharmaceutical Regulatory Intelligence
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Budesonide in South Africa
43 products registered with SAHPRA — 28 active
| Brand / Product | Reg. No. | Holder | Status | Expires |
|---|---|---|---|---|
| BUDEFLAM 0,5 mg/ml RESPULES | 57/21.5.1/0003 | Cipla Medpro (Pty) Ltd | active | 18 Mar 2030 |
| BUDEFLAM 0,123 mg/ml RESPULES | 57/21.5.1/0001 | Cipla Medpro (Pty) Ltd | active | 18 Mar 2030 |
| BUDESONIDE 0,125 mg/ml RESPULES CIPLA | 57/21.5.1/0004.001 | Cipla Medpro (Pty) Ltd | active | 18 Mar 2030 |
| BUDEFLAM 0,25 mg/ml RESPULES | 57/21.5.1/0002 | Cipla Medpro (Pty) Ltd | active | 18 Mar 2030 |
| BUDESONIDE 0,25 mg/ml RESPULES CIPLA | 57/21.5.1/0005.002 | Cipla Medpro (Pty) Ltd | active | 18 Mar 2030 |
| BUDESONIDE 0,5 mg/ml RESPULES CIPLA | 57/21.5.1/0006.003 | Cipla Medpro (Pty) Ltd | active | 18 Mar 2030 |
| INOXAB 200 | 54/21.5.1/0610 | Macleods Pharmaceuticals SA (Pty) Ltd | active | 24 Oct 2028 |
| PRESSIDO 200 | 54/21.5.1/0611.610 | Macleods Pharmaceuticals SA (Pty) Ltd | active | 24 Oct 2028 |
| HALECORD 400/12 | 55/21.5.1/0324 | Innovata Pharmaceuticals | unknown | 8 Aug 2028 |
| HALECORD 100/6 | 55/21.5.1/0322 | Innovata Pharmaceuticals | unknown | 8 Aug 2028 |
| HALECORD 200/6 | 55/25.5.1/0323 | Innovata Pharmaceuticals | unknown | 8 Aug 2028 |
| BUDEFLAM 200 DP-CAPS | 36/21.5.1/0258 | Cipla Medpro (Pty) Ltd | suspended | 18 Jul 2025 |
| BUDEFLAM AQUANASE | 33/21.5.1/0045 | Cipla Medpro (Pty) Ltd | suspended | 18 Jul 2025 |
| CIPLA BUDESONIDE 100 DP-CAPS | 36/21.5.1/0249 | Cipla Medpro (Pty) Ltd | suspended | 18 Jul 2025 |
| BUDEFLAM 100 DP-CAPS | 36/21.5.1/0257 | Cipla Medpro (Pty) Ltd | suspended | 18 Jul 2025 |
| PULMICORT TURBUHALER 100 ug/dose | Y/21.5.1/171 | AstraZeneca Pharmaceuticals (Pty) Ltd | suspended | 17 Mar 2023 |
| PULMAX 400 MDI | 37/21.5.1/0015 | Biotech Laboratories (Pty) Ltd | suspended | 19 Jan 2023 |
| PULMAX 200 MDI | 37/21.5.1/0014 | HEXAL PHARMA (PTY) LTD | suspended | 19 Jan 2023 |
| PULMAX 100 MDI | 37/21.5.1/0013 | Biotech Laboratories (Pty) Ltd | suspended | 19 Jan 2023 |
| INFLACOR 400 | 35/21.5.1/0165 | Teva Pharmaceuticals (Pty) Ltd | suspended | 14 Sept 2022 |
| INFLACOR 200 | 35/21.5.1/0164 | Teva Pharmaceuticals (Pty) Ltd | suspended | 14 Sept 2022 |
| PULMICORT TURBUHALER 400 ug/dose | Z/21.5.1/266 | AstraZeneca Pharmaceuticals (Pty) Ltd | suspended | 26 Apr 2022 |
| PULMICORT NEBULISING SUSPENSION 0,125 mg/ML | 30/21.5.1/0018 | AstraZeneca Pharmaceuticals (Pty) Ltd | suspended | 26 Apr 2022 |
| PULMICORT NEBULISING SUSPENSION 0,25 mg/ml | 30/21.5.1/0017 | AstraZeneca Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| PULMICORT TURBUHALER 200 ug/dose | Y/21.5.1/172 | AstraZeneca Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| SPEC BUDESONIDE 100 | A40/21.5.1/0224 | Specpharm (Pty) Ltd | active | 1 Jan 1900 |
| BUDAIR 0,25 mg/ml | 53/21.5.1/0237 | Ranbaxy Pharmaceutical (Pty) Ltd | active | 1 Jan 1900 |
| BUDAIR 0,5 mg/ml | 53/21.5.1/0238 | Ranbaxy Pharmaceutical (Pty) Ltd | active | 1 Jan 1900 |
| SYMBICORD TURBUHALER 320:9 ug/DOSE | 38/21.5.1/0187 | AstraZeneca Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| BUDEFLAM 200 | 32/21.5.1/0115 | Cipla Medpro (Pty) Ltd | active | 1 Jan 1900 |
| PULMICORT NEBULISING SUSPENSION 0,5 mg/ml | 30/21.5.1/0016 | AstraZeneca Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| SYMBICORD TURBUHALER 80:4,5 ug/DOSE | 35/21.5.1/0404 | AstraZeneca Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| SYMBICORD TURBUHALER 160:4,5 ug/DOSE | 35/21.5.1/405 | AstraZeneca Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| VANNAIR 80:4,5 | A39/21.5.1/0506 | AstraZeneca Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| VANNAIR 160:4,5 | A39/21.5.1/0507 | AstraZeneca Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| ENTOCORD 3 mg | 31/21.5.1/0215 | Equity Pharmaceutical (Pty) Ltd | active | 1 Jan 1900 |
| AEROMIDE NASAL 100 | 41/21.5.1/0238 | Activo Health (Pty) Ltd | active | 1 Jan 1900 |
| BUDONEB 0,25 mg/ml | 42/21.5.1/0953 | Teva Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| AEROMIDE NASAL 50 | 32/21.5.1/0532 | Activo Health (Pty) Ltd | active | 1 Jan 1900 |
| ENTOCORD 0,02 mg/ml | 29/11.8/0638 | Equity Pharmaceutical (Pty) Ltd | active | 1 Jan 1900 |
| BUDONEB 0,5 mg/ml | 42/21.5.1/0954 | Teva Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| ARROW BUDESONIDE 0,25 mg/ml | 42/21.5.1/0955 | Teva Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| ARROW BUDESONIDE 0,5 mg/ml | 42/21.5.1/0956 | Teva Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
Budesonide — SAHPRA Registration Details
SAHPRA (South Africa) has 43 registered products containing Budesonide, of which 28 are currently active. Data is sourced directly from the official SAHPRA drug register and refreshed daily.
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