Capling Point Laboratories has announced receiving Establishment Inspection Report from the US health regulator for its Gummidopoondi facility in Chennai.
In a filing to BSE and NSE, it said, “Caplin Point has received the Establishment Inspection Report (EIR) from USFDA (The United States Food and Drug Administration) for inspection carried out during Oct 21-27, 2016, at its sterile injectable plant at Gummidopoondi in Tamil Nadu.”
According to Caplin Point Laboratories Chairman C C Paarthipan, “this will pave the way for our entry into the largest pharma market in the world.”
The facility, capable of manufacturing liquid injectables in vials, ampoules, lyophilized vials and ophthalmic dosages, is approved by EU-GMP and ANVISA-Brasil.
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