This approval is from Sun Pharmaâ€™s Halol (Gujarat, India) facility.
Shares of Sun Pharmaceutical Industries and Sun Pharma Advanced Research Company gained 3-7 percent in the opening trade on Friday on the back of USFDA approval for Xelpros which is used to treat open-angle Glaucoma or Ocular Hypertension.
The company announced USFDA (US Food and Drug Administration) approval for the new drug application (NDA) of Xelprostm (latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Sun Pharma in-licensed Xelprostm from SPARC in June 2015 and this approval will trigger a milestone payment to SPARC. SPARC is also eligible for milestone payments and royalties on commercialization of Xelprostm in the US.
Xelprostm is the first and only form of latanoprost that is not formulated with benzalkonium chloride (BAK), a preservative commonly used in topical ocular preparations. Xelprostm is developed using SPARCâ€™s proprietary Swollen Micelle Microemulsion (SMM) technology.
At 09:18 hrs Sun Pharmaceutical Industries was quoting at Rs 664.10, up 2.19 percent and Sun Pharma Advanced Research Company was quoting at Rs 401.75, up 4.77 percent on the BSE.