AUROBINDO GRANTED SOUTH AFRICAN APPROVAL FOR FACILITY, DRUGS
Indian drugmaker Aurobindo Pharma has announced that South Africa's Medicines Control Council has inspected the company's facility in Hyderabad, India, and found it to be in compliance with current good manufacturing practices. The council recommends the registration of products manufactured there with South African authorities.
Additionally, South African regulators have approved four generic HIV antiretrovirals made at Aurobindo's Hyderabad plant. The formulations are: lamivudine 150-mg tablets, zidovudine 300-mg tablets, nevirapine 200-mg tablets and tablets containing 150 mg of lamivudine plus 300 mg of zidovudine. While lamivudine and zidovudine belong to the class of nucleoside reverse transcriptase inhibitors, nevirapine is a non-nucleoside reverse transcriptase inhibitor.
The Hyderabad facility is also approved by authorities in the U.S., the UK and Brazil, among others. The plant is capable of manufacturing injectables, powder for oral suspensions, tablets and capsules, in addition to active pharmaceutical ingredients.
Upcoming Events
-
21Oct