Aurobindo Pharma spurts on receiving USFDA approval for Bupivacaine Hydrochloride Injection

16 May 2016 Evaluate

Aurobindo Pharma is currently trading at Rs.792.35, up by 6.30 points or 0.80% from its previous closing of Rs. 786.05 on the BSE.

The scrip opened at Rs. 785.00 and has touched a high and low of Rs. 799.10 and Rs. 785.00 respectively. So far 24613 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 1 has touched a 52 week high of Rs. 891.50 on 30-Dec-2015 and a 52 week low of Rs. 582.00 on 25-Feb-2016.

Last one week high and low of the scrip stood at Rs. 823.55 and Rs. 781.75 respectively. The current market cap of the company is Rs. 46433.21 crore.

The promoters holding in the company stood at 53.79% while Institutions and Non-Institutions held 34.67% and 11.54% respectively.

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Bupivacaine Hydrochloride Injection USP, 0.25% (2.5 mg/mL) and 0.5% (5 mg/mL) 50 mL multiple dose vials. This product is expected to be launched in Q2 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Marcaine Injection, 0.25% and 0.5% of Hospira, Inc.

Bupivacaine Hydrochloride Injection is used for the production of local or regional anesthesia or analgesia for surgery, diagnostic and therapeutic procedures, and for obstetrical procedures. The approved product has an estimated market size of $5.6 million for the twelve months ending March 2016, according to IMS.

This is the 32nd ANDA (including two tentative approvals) to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable products. Aurobindo now has a total of 262 ANDA approvals (224 Final approvals including 11 from Aurolife Pharma LLC and 38 tentative approvals) from USFDA.

Aurobindo Pharma Share Price

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