Lupin receives tentative approval for generic version of Pfizer’s Zithromax

zithromaxPharma Major Lupin Limited announced that its US subsidiary, Gavis Pharmaceuticals LLC., received tentative approval for selling a generic version of Pfizer Inc.’s Zithromax oral suspension from the US FDA.

Lupin had earlier received final approval for its Azithromycin Tablets and Azithromycin for Oral Suspension, filed from its Goa plant.

Azithromycin per bottle are the AB rated generic equivalent of Pfizer Inc.’s Zithromax and can be substituted by the pharmacist. Non-AB rate equivalents may not be substituted by the pharmacist without the permission from the doctor as they are considered therapeutic alternatives and not generic substitutes.

Zithromax is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria and had US sales of $ 110.6 million (IMS MAT June 2016).

Lupin is a transnational pharmaceutical company producing and developing a wide range of
branded & generic formulations, biotechnology products and APIs globally.

For the financial year ended 31st March, 2016, Lupin’s Consolidated sales and Net profit stood at Rs 136,539 million ($ 2.09 billion) and Rs 22,607 million ($ 345 million) respectively.