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S&P
BSE SENSEX
73,651.35
+655.04
+0.90 %
Corporate Announcement
Security Code
532300
Company
WOCKHARDT LTD.
Exchange Received Time
21/03/2017 17:15:08
Exchange Disseminated Time
21/03/2017 17:15:16
Time Taken
00:00:08
Updates |
3/21/2017 5:15:08 PM
This is to inform the Exchanges that abbreviated new drug application ('ANDA') of Piperacillin and Tazobactam for Injection USP, 40.5 g/vial, pharmacy bulk package submitted by Wockhardt Bio AG (Wockhardt), Subsidiary of the Company has been approved by U.S. Food and Drug Administration ('USFDA'). Wockhardt's ANDA was determined to be therapeutically equivalent to the reference listed drug (RLD) Zosyn for Injection 40.5g/vial, pharmacy bulk package of Wyeth Pharmaceuticals Inc. Wockhardt Bio AG had filed this ANDA in collaboration with Fresinius Kabi, Italy ('FKAI'), where the product development was completed. The ANDA will be manufactured commercially at FKAI, Mitim, Italy.
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