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SUN PHARMA GLOBAL FZE is a free zone limited liability establishment incorporated in Sharjah Airport International Free Zone, Sharjah, U. A. E. pursuant to Emiri Decree # 2 of 1995 and in accordance with the implementation procedures of the free zone establishment.
Sun Pharma Global FZE, c/o Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ 08540. Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of April 13, 2018.
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At this time, FDA’s regulatory discretion for the importation and distribution of Sun Pharma’s Lipodox™ (Doxorubicin Hydrochloride Liposome Injection) is limited to Sun Pharma Global FZE and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd, during the critical shortage of Doxil.