Aurobindo Pharma receives approval from South African Health Products Regulatory Authority for latest fixed dose triple combination tablets
Deepthi | Myequity news | Date : 18-09-2018 11:00:00 IST
Aurobindo Pharma Limited is pleased to announce that the company has received approval from the South African Health Products Regulatory Authority (SAHPRA) for its Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (DLT) tablets, 50mg/300mg/300mg, the first-line preferred regimen for HIV patients as per latest WHO guidelines.
Aurobindo is now among the first few companies which has received approval for this product. This approval demonstrates our commitment towards HIV patients and enables the company to participate in South African HIV tender as well as launch in private market. The approval further strengthens Aurobindo's HIV product basket in South Africa, which has the potential to improve the lives of millions of patients. About Aurobindo Pharma Limited:
Prior to SAHPRA's approval, Aurobindo has received tentative approval for the drug from US Food and Drug Administration and launched in Sub-Saharan African markets as part of its commitment to bring affordable HIV drugs to millions of patients globally.
Aurobindo Pharma Limited headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company's manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. The company's robust product portfolio is spread over 7 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, Anti-Allergies and Anti- Diabetics, supported by an outstanding R&D set-up. The Company is marketing these products globally, in over 150 countries.