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SPARC gains on receiving CRL from USFDA for Latanoprost NDA

Sun Pharma Advanced Research Company Ltd. | Business Support | Miscellaneous | BSE: 532872 | NSE: SPARC

03 Aug 2015 Evaluate

Sun Pharma Advanced Research Company (SPARC) is currently trading at Rs. 414.00, up by 5.20 points or 1.27% from its previous closing of Rs. 408.80 on the BSE.

The scrip opened at Rs. 409.50 and has touched a high and low of Rs. 414.75 and Rs. 409.50 respectively. So far 6.416 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 1 has touched a 52 week high of Rs. 598.00 on 10-Mar-2015 and a 52 week low of Rs. 158.90 on 13-Aug-2014.

Last one week high and low of the scrip stood at Rs. 415.10 and Rs. 396.10 respectively. The current market cap of the company is Rs. 9,757.00 crore.

The promoters holding in the company stood at 67.13% while Institutions and Non-Institutions held 7.29% and 25.58% respectively.

Sun Pharma Advanced Research Company (SPARC) has received Complete Response letter (CRL) from U.S. Food and Drug Administration (USFDA) to its New Drug Application (NDA) for Xelpros, Latanoprost BAK-free eyedrops. The company has submitted a response to an earlier CRL it had received from the USFDA, wherein no additional preclinical or clinical data was required. While the USFDA has accepted the clarifications and changes to the labeling, company has now received another CRL from the USFDA seeking minor changes to the proposed labeling. The company hopes to address these requirements soon.

This product is to be manufactured at SPIL’s Halol facility and the USFDA has indicated that a satisfactory resolution of the cGMP deficiencies at this facility is a prerequisite for the final approval of Xelpros. SPARC had recently out-licensed this product to a subsidiary of Sun Pharmaceutical Industries (SPIL).

Sun Pharma Advanced Research Company is an international pharmaceutical company engaged in research and development of drugs and delivery systems.

Sun Pharma Adv. Res Share Price

147.90 -4.25 (-2.79%)

17-Apr-2026 16:59 View Price Chart

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SPARC gains on receiving CRL from USFDA for Latanoprost NDA

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