Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Azithromycin Oral Suspension 100 mg /5 mL and 200 mg/5 mL. Azithromycin oral suspension, a generic version of Pfizer Inc’s Zithromax oral suspension. The product will be launched in November 2018.
Azithromycin oral suspension is indicated for the treatment of patients with mild to moderate infections. According to IQVIA, the approved product has an estimated market size of $71 million for the twelve months ending August 2018.
This is the 125th ANDA (including 11 tentative approvals) to be approved out of Unit III formulation facility in Hyderabad, India used for manufacturing oral products. Aurobindo now has a total of 386 ANDA approvals (357 Final approvals including 19 from Aurolife Pharma LLC and 29 tentative approvals) from USFDA.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1872.40 |
| Dr. Reddys Lab | 1279.70 |
| Cipla | 1304.70 |
| Zydus Lifesciences | 956.65 |
| Lupin | 2245.65 |
| View more.. | |
MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.
To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.
MoneyWorks4Me ensures this through: