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Sun Pharma's arm receives USFDA’s approval for ELEPSIA XR 1000mg, 1500mg

21 Dec 2018 Evaluate

Sun Pharmaceutical Industries’ wholly owned subsidiary has received approval from US Food and Drug Administration (USFDA) for the New Drug Application (NDA), for Elepsia XR 1000 mg (levetiracetam 1000 mg) and Elepsia XR 1500 mg (levetiracetam 1500 mg). This product was filed from SPIL’s Halol facility in the state of Gujarat.

The company’s wholly owned subsidiary had in-licensed ELEPSIA XR from Sun Pharma Advanced Research Company (SPARC) in July 2016.

Sun Pharmaceutical Industries (SPIL) is the world’s fourth largest specialty generic pharmaceutical company and India’s top pharmaceutical company.

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Company Name CMP
Sun Pharma. Inds. 1788.00
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Cipla 1330.05
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