 "Sun Pharma's manufacturing plant")
Shares of Sun Pharmaceutical Industries and Sun Pharma Advanced Research Company (SPARC) were down 4% each after the US Food and Drugs Administration (USFDA) withdrew an approval granted in March to SPARC’s anti-epileptic drug due to regulatory compliance issues at Sun Pharma's Halol plant.
Among individual stocks, SPARC has dipped 4.4% at 369, while Sun Pharma was down nearly 4% to Rs 858 on the BSE. The S&P BSE Sensex was down 0.34% at 25,776 points at 10:02 a.m.
"The USFDA have issued a Complete Response letter (CRL) to the company's new drug application (NDA) for Elepsia XR (Levetiracetam extended-release tablets 1000 mg and 1500 mg)," SPARC said in a statement.
The company had earlier received a final approval from USFDA in March 2015 for this product and was evaluating several marketing partners for commercialization.
However, SPARC has now received a CRL from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval, it added.
Elepsia XR is to be manufactured at Sun Pharma’s Halol facility. The company is working with USFDA in resolving the current good manufacturing practice (cGMP) deviations at the facility and has taken several corrective measures.
Among individual stocks, SPARC has dipped 4.4% at 369, while Sun Pharma was down nearly 4% to Rs 858 on the BSE. The S&P BSE Sensex was down 0.34% at 25,776 points at 10:02 a.m.
"The USFDA have issued a Complete Response letter (CRL) to the company's new drug application (NDA) for Elepsia XR (Levetiracetam extended-release tablets 1000 mg and 1500 mg)," SPARC said in a statement.
The company had earlier received a final approval from USFDA in March 2015 for this product and was evaluating several marketing partners for commercialization.
However, SPARC has now received a CRL from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility was not acceptable on the date of approval, it added.
Elepsia XR is to be manufactured at Sun Pharma’s Halol facility. The company is working with USFDA in resolving the current good manufacturing practice (cGMP) deviations at the facility and has taken several corrective measures.
"This is a near-term setback to the companies 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 companies Halol facilities will take time to resolve, though company has indicated that it is taking corrective actions for rectifying the same. Though a setback, we have not factored in the same in our numbers. We maintain our accumulate rating on the stock with a price target of Rs 950," said Sarabjit Kour Nangra, Vice-President - Research (Pharma) at Angel Broking in a note.
