Aurobindo Bags USFDA Nod For Lamivudine & Zidovudine Tabs

Aurobindo Bags USFDA Nod For Lamivudine & Zidovudine TabsAurobindo Pharma Limited has pocketed final authorization from the US Food and Drug Administration (FDA) to produce and sell lamivudine and zidovudine tabs USP 150/300mg (ANDA 202418).

Hyderabad-based pharma major said that it is ready to launch the Lamivudine and zidovudine pills in the market.

Lamivudine and zidovudine tabs, the generic equivalent of ViiV Healthcare firm's Combivir tabs, are prescribed as part of antiretroviral (ARV) combination therapy for the cure of HIV infected people.

The twelve-monthly sale of Lamivudine and zidovudine tabs stood at US$ 265 million.

The product was sanctioned out of Unit VII formulations plant of Aurobindo Pharma Limited in Hyderabad, India.

Now, the pharma giant has a total of 150 ANDA nods (122 final nods comprising 1 from Aurolife Pharma LLC and 28 tentative sanctions) from US Food and Drug Administration.

The company has production plants, which are sanctioned by several leading regulatory firms such as US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, Anvisa Brazil.

The company’s shares, on Friday (May 18), closed at Rs 108.05 after surging 1.8% on the Bombay Stock Exchange (BSE).

The share price has seen a 52-week high of Rs 193.20 and a low of Rs 82.25 on BSE.

Current EPS & P/E ratio of the stock stood at 20.30 & 5.32 respectively.