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SPARC seeks approval for drugs from alternate sites

Elepsia, Xelpros failed to receive approval from US drug regulator

SPARC seeks approval for drugs from alternate sites
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Aneesh Phadnis Mumbai:
Failing to receive product approval from US drug regulator (US FDA), Sun Pharma's research arm will initiate site transfer for its anti epilepsy drug Elepsia and eye drop Xelpros.

Both products were filed from Sun Pharma's Halol plant which received US Food and Drug Administration's warning letter in 2015. The two products did not receive approval. Sun Pharmaceutical Advanced Research Company (SPARC) now plans to resubmit its application for product approval to the regulator from an alternate site, chief executive officer Anil Raghavan said on Thursday.

SPARC licensed these products under development drugs to Sun Pharma in lieu of an