“Solara Visakhapatnam facility completes USFDA Inspection with Zero 483 inspectional observations,” said the company in a filing to the stock exchange.
The inspection established that the site is in an “Acceptable State of Compliance” with Zero Form 483 inspectional observations from the US FDA.
The US FDA agency with their designated investigator inspected the facility from 14th to 17th May. Solara’s Visakhapatnam (Vizag) facility is a green field project spread over an area of 40 acres and has dedicated facilities for the manufacture of Ibuprofen API.
Solara Active Pharma Sciences Limited (Solara) is an Active Pharmaceutical Ingredient (API) provider and works with pharma companies.
“We are very happy with the successful inspection outcome of our Visakhapatnam API site with Zero 483 inspectional observations. This is the second US FDA inspection we have undergone at this site” said Poorvank Purohit, MD & CEO, Solara.The company now has two FDA-inspected manufacturing sites (Puducherry and Visakhapatnam) for Ibuprofen drug substance.The facility also manufactures its key starting material for Ibuprofen and thus achieves backward integration of its critical supply chain and ensures business continuity for its customers. Solara’s (Vizag) facility has also started validation of other API’s to register in various regulated markets across the globe.
Solara has 6 manufacturing facilities and an R&D Centre. Its API facilities are approved by various international regulatory agencies including the USFDA, EDQM, MFDS, WHO, PMDA etc.
The shares of Solara Active Pharma Sciences Ltd closed at Rs 482 during the last trading session at the National Stock Exchange.
