Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Amlodipine Besylate and Benazepril Hydrochloride Capsules 2.5mg/10mg, 5mg/20mg, 5mg/40mg, 10mg/20mg, and 10mg/40mg (ANDA 202239). The products are ready for launch.
Amlodipine Besylate and Benazepril Hydrochloride Capsules are the generic bioequivalent to the reference listed drug Lotrel Capsules of Norvatis Pharmaceutical Corp. According to IMS, the annual sales of Amlodipine Besylate and Benazepril Hydrochloride Capsules is about $500 million for the twelve months ending March 2012.
The products have been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India. The company now has a total of 158 ANDA approvals - 133 final approvals including 1 from Aurolife Pharma LLC and 25 tentative approvals from USFDA.
Aurobindo Pharma has a product presence in key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardio-vascular, gastroenterology, etc. The company is the market leader in semi-synthetic penicillin drugs.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1675.20 |
| Dr. Reddys Lab | 1235.40 |
| Cipla | 1238.30 |
| Zydus Lifesciences | 942.55 |
| Lupin | 2324.25 |
| 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: