Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Metformin Hydrochloride Extended-Release (ER) Tablets USP 500mg and 750mg (ANDA 079118). The product is ready for launch.
Metformin Hydrochloride ER Tablets USP 500mg and 750mg is the generic equivalent of Bristol Myers Squibb Company (BMS)'s Glucophage XR Extended-release Tablets 500mg and 750mg respectively. Metformin Hydrochloride ER Tablets are oral anti-hyperglycemic drugs indicated as an adjunct to diet and exercise to improve glycemic control in patients with type-2 diabetes. The annual sale of the product is approximately $230 million.
The product has been approved out of Unit III formulations facility in Hyderabad, India. The company now has a total of 153 ANDA approvals (127 Final approvals including 1 from Aurolife Pharma LLC and 26 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. | 1532.85 |
Dr. Reddys Lab | 5812.50 |
Cipla | 1403.90 |
Zydus Lifesciences | 1104.45 |
Lupin | 1661.90 |
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