BackSun Pharma, SPARC shares fall after US FDA revokes approval for drug
Agency says it has revoked the approval issued to SPARC, a subsidiary of Sun, in March 2015 over compliance issues at Sun's Halol plant in Gujarat
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Mumbai: Shares of Sun Pharmaceutical Industries Ltd (SPIL) on Monday fell 3.26% to close at ₹ 862.2 a piece on BSE after the US Food and Drugs Administration (US FDA) withdrew its approval for anti-epileptic drug made by its subsidiary Sun Pharma Advanced Research Company Ltd (SPARC).
The US FDA has issued a Complete Response Letter (CRL) to SPARC on its New Drug Application for Elepsia XR (Levetiracetam extended-release tablets 1,000mg and 1,500mg).
In a note, the agency said it has revoked the approval issued to SPARC in March 2015, citing compliance issues at Sun’s Halol plant in Gujarat.
On Friday, shares of SPARC fell 2.29% to close at ₹ 377.05 apiece on the BSE, while the benchmark Sensex lost 0.95% to 25,616.84 points. SPARC shares fell 4.5% to ₹ 368.5 in morning trade.
“SPARC had earlier received a final approval from US FDA in March 2015 for this product and was evaluating several marketing partners for commercialization. However SPARC has now received a CRL (Complete Response Letter) from the US FDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval," the company said in a statement.
SPIL is working with US FDA in resolving the CGMP (current good manufacturing practices) deviations at the facility and has taken several corrective measures, it added.
“This is a near-term setback to the company’s plan to launch the product, as we believe that once the facilities are approved the company will be able to launch the product. However, it is indicative of the fact that the company’s Halol facilities will take time to resolve (compliance issues), though company has indicated that it is taking corrective actions for rectifying the same," said Sarabjit Kour Nangra, vice-president-research (pharma) at Angel Broking Privte Ltd.
The withdrawal of US FDA approval comes at a time when SPARC is evaluating marketing partners for commercialization of the drug.
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