New Delhi: US Food and Drug Administration (US FDA) has successfully completed the inspection of the multipurpose API Manufacturing Facility Of Solara Active Pharma Sciences Ltd (on solara) VisakhapatnamAndhra Pradesh.
,Solara Visakhapatnam Facility Completes USFDA inspection with 0 483 observational comments” the company said 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 comments from the US FDA.
The US FDA agency along with its designated investigator inspected the facility from 14 to 17 May. Solara’s Visakhapatnam (Vizag) facility is a green field project spread over an area of 40 acres and has dedicated facilities for manufacturing. ibuprofen api,
Solara Active Pharma Sciences Ltd. (Solara) is an active pharmaceutical ingredient (API) provider and works with pharma companies.
“We are very pleased with the successful inspection result of our Visakhapatnam API site zero 483 observational Overview. This is another America FDA inspection We have worked on this site” said Purvank Purohit, MD and CEO, Solara.
The company now has two Manufacturing sites inspected by FDA (For Puducherry and Visakhapatnam) ibuprofen drug substance,
The facility also produces its key starting material for ibuprofen and thus achieves its backward integration. critical supply chain and ensures business continuity for its customers. The Solara (Vizag) facility has also begun validation of other APIs to register in various regulated markets around the world.
Solara has 6 manufacturing facilities and a R&D centre. Its API facilities are approved by various international regulatory agencies including USFDA, EDQM, MFDS, WHO, PMDA, etc.
shares of Solara Active Pharma Sciences Ltd. closed at Rs 482 during the last trading session on the National Stock Exchange.
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