Aurobindo Pharma receives USFDA approvals for Ampicillin & Sulbactam for Injection

Aurobindo Pharma Ltd has received final approvals from the US Food & Drug Administration (USFDA) for 3 ANDAs namely, Ampicillin & Sulbactam for Injection 1.5g and 3.0g (Infusion bottles), Ampicillin & Sulbactam for Injection 1.5g and 3.0g (single use vials) and Ampicillin & Sulbactam for Injection 15g USP (Pharmacy Bulk Pack).

Ampicillin & Sulbactam for Injection USP is a Sterile Semi Synthetic Penicillin (SSP) product falling under the anti-infective segment and is generic equivalent to Pfizer Inc's Reference Listed Drug Unasyn for injections. Ampicillin & Sulbactam for Injection USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in conditions such as skin and skin structure infections, intra-abdominal infections and gynecological infections.

The product has a market size of approximately US$ 50Million according to IMS as of June 2009 and is ready for launch. With these approvals, Unit XII, a penicillin Sterile Injectable Formulation facility situated in Hyderabad, India now has 5 injectable products approved by USFDA.

Aurobindo now has a total of 126 ANDA approvals (97 Final approvals and 29 Tentative approvals) from USFDA.

The stock was trading at Rs.1061.10, up by Rs.13.30 or 1.27%. The stock hit an intraday high of Rs.1070 and low of Rs.1025.25.

The total traded quantity was 93430.

Source : Equity Bulls

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