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news.Aurobindo Pharma has received tentative approval to manufacture and market Nevirapine tablets for oral suspension 50mg from the FDA.
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The new drug application 22-299 provides for the use of Nevirapine tablets for oral suspension 50mg in combination with other antiretrovirals and its indicated for the treatment of HIV infections.
Aurobindo has a total of 113 ANDA approvals (84 final approvals and 29 tentative approvals) from the FDA.
Aurobindo Pharma, headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several regulatory agencies like FDA, MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.