Aurobindo receives approval from Medicines Control Council (MCC) to market nine products in South Africa. The products are said to have a generic market size of 165 million South African brands in the local market
Pharmaceutical firm Aurobindo Pharma Ltd has received approval from the MCC to manufacture and market nine products in South Africa. These products have a generic market size of 165 million South African brands in the local market. The company has received approvals for several facilities from leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.
Aurobindo now has 31 marketing authorizations approved by the MCC, the company added. Out of the nine products — Zinoxime and Yomax — are anti-infective while Auro-Lisinopril Co, Auro-Amlodipine and Lisinozide are cardio-vascular drugs.
The other products that received the approval include — Auro-Finasteride, Zolid, Lazivir and Profina.
The products approved are as follows:
| # | Product Name | Active Ingredient | Dosage Form | Strength | Category |
| 1 | Auro-Lisinopril Co | Lisinopril+HCTZ | FDC | 10+12.5mg, 20+12.5mg | CVS |
| 2 | Auro-Amlodipine | Amlodipine | Tablet | 5mg, 10mg | CVS |
| 3 | Auro-Finasteride | Finasteride | Tablet | 5mg | BPH |
| 4 | Zinoxime | Cefuroxime Axetil | Tablet | 125mg, 250mg, 500mg | Anti-infective |
| 5 | Zolid | Sertraline HCL | Tablet | 50mg, 100mg | CNS |
| 6 | Yomax | Amoxycillin | Capsules | 250mg, 500mg | Anti-infective |
| 7 | Lazivir | Lamivudine/Zidovudine+Abacavir | FDC | 150/300+300 mg | ARV |
| 8 | Lisinozide | Lisinopril+HCTZ | Tablet | 10mg, 20mg | CVS |
| 9 | Profina | Finasteride | Tablet | 5mg | BPH |
| (FDC Fixed Dose Combination, CVS: Cardio Vascular System, BPH: Benign Prostatic Hyperplasia, CNS: Central Nervous System, ARV: Anti-RetroVirals) | |||||
