Pharma major, Lupin’s subsidiary - Lupin Pharmaceuticals Inc (LPI) has been granted the final approval by the United Food & Drug Administration (USFDA) for the company’s abbreviated drug application (ANDA) for Amlodipine/ Benazepril 5mg/40mg and 10 mg/40 mg capsules. The commercial shipments of the products have commenced.
This approval completes the product line as the company was granted final approval for Amlodipine/Benazepril 2.5 mg/ 10 mg, 5mg/10mg, 5mg/20 mg and 10 mg/20 mg capsules in February 2010.
Lupin’s Amlodipine/ Benazepril capsules are the AB rated generic equivalents of the Novartis Lotrel capsules indicated for the treatment of hypertension. Amlodipine/ Benazepril 5mg/40mg and 10 mg/40 mg capsules had annual sales of approximately $290 million for the twelve months ended March 2011.
| Company Name | CMP |
|---|---|
| Sun Pharma. Inds. | 1913.05 |
| Dr. Reddys Labs. | 1368.75 |
| Cipla | 1471.25 |
| Zydus Lifesciences | 1148.05 |
| Lupin | 2492.45 |
| View more.. | |
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