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Sun Pharma Advanced Research Company (SPARC) rallied 7% to Rs 328 on the BSE in early morning trade after the company said it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (USFDA) for New Drug Application (NDA) for Xelpros, Latanoprost BAK-free eyedrops.
“The CRL reference the recent inspection of the Sun Pharmaceutical Industries Halol manufacturing plant site by USFDA and indicates that satisfactory resolution of the deficiencies identified during the inspection is required before the final approval of Xelpros,” SPARC said in a statement.
There are no requirements of any additional data from USFDA in the CRL.
SPARC had out-licensed Xelpros to a subsidiary of Sun Pharmaceutical Industries in June 2015.
At 09:27 am; the stock of SPARC was up 4% at Rs 320 on the BSE as compared to 0.39% decline in the S&P BSE Sensex. The trading volumes on the counter nearly doubled with a combined 483,290 equity shares changed hands on the BSE and NSE.
Sun Pharma was up 1% at Rs 622 on the BSE after hitting high of Rs 625 in early morning trade. The stock had underperformed the market by falling 15% in past 14 trading days, as compared to 1.2% decline in the benchmark index till Wednesday.
“The CRL reference the recent inspection of the Sun Pharmaceutical Industries Halol manufacturing plant site by USFDA and indicates that satisfactory resolution of the deficiencies identified during the inspection is required before the final approval of Xelpros,” SPARC said in a statement.
There are no requirements of any additional data from USFDA in the CRL.
SPARC had out-licensed Xelpros to a subsidiary of Sun Pharmaceutical Industries in June 2015.
At 09:27 am; the stock of SPARC was up 4% at Rs 320 on the BSE as compared to 0.39% decline in the S&P BSE Sensex. The trading volumes on the counter nearly doubled with a combined 483,290 equity shares changed hands on the BSE and NSE.
Sun Pharma was up 1% at Rs 622 on the BSE after hitting high of Rs 625 in early morning trade. The stock had underperformed the market by falling 15% in past 14 trading days, as compared to 1.2% decline in the benchmark index till Wednesday.
