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Zydus Cadila receives final approval for Cisatracurium Besylate Injection from USFDA

Zydus Cadila receives final approval for Cisatracurium Besylate Injection from USFDA

Mumbai, Sep 2 (UNI) Pharma major, Zydus Cadila said that it has received final approval from the USFDA to market Cisatracurium Besylate Injection USP in the strength of 20 mg (base)/10 mL (2 mg/mL) Multiple-Dose Vial.

Cisatracurium Besylate is a nondepolarizing skeletal neuromuscular blocker for intravenous administration, company said in a filing with BSE.

It is an adjunct to general anaesthesia to facilitate tracheal intubation in adults and in paediatric patients 1 month to 12 years of age and to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU.

The drug will be manufactured at Liva plant of Cadila Healthcare Limited.

The group now has 297 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.

UNI JS SB 1249

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