Live news , top stories, corporate news, company news, sector news, economy news, results analysis news, ceo interviews, fund manager interview, advisor interview, market news, bazaar talk, hot stocks news, ipo news, commodities news, mutual fund news, insurance news, news wire
29 February, 2020 02:36 IST
Aurobindo Pharma receives USFDA approval for Ertapenem injection
Source: IRIS | 26 Jun, 2018, 09.36AM
Comments  |  Post Comment

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Ertapenem Injection 1 g/vial.

Aurobindo's Ertapenem injection is a generic equivalent of Merck Sharp & Dohme Corp's Invanz Injection. The product will be launched in July 2018.

The approved product has an estimated market size of USD 387 million for the twelve months ending Apr 2018 according to IQVIA. Ertapenem injection is used for the treatment of moderate to severe infections caused by susceptible bacteria. Also indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.

This ANDA is approved out of Auronext Pharma's (wholly owned subsidiary) formulation facility in Bhiwadi, India used for manufacturing penem injectable products. Aurobindo now has a total of 371 ANDA approvals (338 Final approvals including 17 from Aurolife Pharma LLC and 33 tentative approvals) from USFDA.

Shares of the company gained Rs 10.35, or 1.7%, to trade at Rs 618.05. The total volume of shares traded was 25,762 at the BSE (9.22 a.m., Tuesday).





Aurobindo Pharma Limited   (Q,N,C,F)*

Comments Post comment 
 Post Comment
Name Email
Comment
Security Code type    into this box
Company Update
DIC India to sell Mumbai land for Rs 1.53 bn to Godrej Properties - 28-Feb-2020 16:51
DIC India to sell Mumbai land for Rs 1.53 bn to Godrej Properties - 28-Feb-2020 16:51
Pidilite Industries to acquire 70% stake in Tenax India - 28-Feb-2020 16:43
ONGC, Hindustan Petroleum buy 17.28% stake each in Petronet MHB - 28-Feb-2020 16:30
ONGC, Hindustan Petroleum buy 17.28% stake each in Petronet MHB - 28-Feb-2020 16:30
Suzlon Energy board approves proposal for restructuring of debt of Co - 28-Feb-2020 16:19
SC orders JP Associates to return to return pledged land to Jaypee - 27-Feb-2020 18:12
Thomas Cook India board approves buy-back of shares worth Rs 1.50 bn - 27-Feb-2020 18:07
TCS ranked no 1 in HFS Top 10 Retail and CPG Services report - 27-Feb-2020 17:56
CONCOR, Joint Stock Co of Russia ink MoU to promote cargo over INSTC - 27-Feb-2020 17:48
Adani Ports and Special Economic Zone incorporates overseas subsidiary - 27-Feb-2020 17:42
more...
Home  |   Shares  |   F&O  |   Mutual Funds  |   Loans  |   Insurance  |   News Centre
Wealth Tracker  |   Newsletters  |   Tax Corner  |   NRI Centre  |   Advertise
© All rights reserved. IRIS Business Services Limited
A Disclaimer