The US Food and Drug Administration (FDA) has approved a new drug application (NDA) for Xelprostm (latanoprost ophthalmic emulsion) 0.005%, an eye-pressure reducer, from Sun Pharmaceutical Industries, a Mumbai, India-headquartered pharmaceutical company, to be produced at the company’s facility in Halol (Gujarat, India). The company recently resumed the product-approval process from the facility following a series of manufacturing issues.

The FDA issued a Warning Letter to Sun Pharma in 2015 as a result of a September 2014 inspection for the company’s facility located at Halol, Gujarat, which manufactures injectable products for the US market. Following the September 2014 inspection, the FDA withheld future product approvals from the Halol facility. The company had been taking steps to remediate the facility since receiving the Warning Letter from the FDA in December 2015. In June 2018, the FDA issued an Establishment Inspection Report to Sun Pharma for its injectables facility in Halol (Gujarat) India and closed its inspection. With the issuance of the report, the product-approval process was able to be resumed at the facility.

Xelprostm is a prostaglandin analogue that is used as first-line treatment for open-angle glaucoma or ocular hypertension. Sun Pharma in-licensed Xelprostm from Sun Pharma Advanced Research Company (SPARC), a biopharmaceutical company formed through a demerger from Sun Pharma, in June 2015. The  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 developed using SPARC’s proprietary Swollen Micelle Microemulsion technology. The drug will be commercialized in the US by Sun Ophthalmics, the branded ophthalmic division of Sun Pharmaceutical Industries’ wholly owned subsidiary.

Source: Sun Pharmaceutical Industries