The approved ANDA is bio-equivalent and therapeutically equivalent to the reference listed drug product (RLD) Acetadote® Injection, 6 g/30 mL, of Cumberland Pharmaceuticals, Inc
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Acetadote® Injection, 6 g/30 mL, of Cumberland Pharmaceuticals, Inc.
Acetylcysteine Injection is an antidote for acetaminophen (non-aspirin pain reliever or analgesic) overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen. The approved product has an estimated market size of US$ 28 million for the twelve months ending December 2015 according to IMS.
This is the 26th 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 242 ANDA approvals (207 Final approvals including 10 from Aurolife Pharma LLC and 35 Tentative approvals) from USFDA.
Aurobindo Pharma Ltd is currently trading at Rs. 665.25, up by Rs. 10.1 or 1.54% from its previous closing of Rs. 655.15 on the BSE.
The scrip opened at Rs. 656 and has touched a high and low of Rs. 671.5 and Rs. 646.25 respectively. So far 1755459(NSE+BSE) shares were traded on the counter. The current market cap of the company is Rs. 38314.45 crore.
The BSE group 'A' stock of face value Rs. 1 has touched a 52 week high of Rs. 891.5 on 30-Dec-2015 and a 52 week low of Rs. 508 on 28-Feb-2015. Last one week high and low of the scrip stood at Rs. 675 and Rs. 582 respectively.
The promoters holding in the company stood at 53.9 % while Institutions and Non-Institutions held 35.24 % and 10.86 % respectively.
The stock is currently trading above its 100 DMA.
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