Indoco Remedies receives EIR from USFDA for sterile, solid dosages facility in Goa
The inspection was held from May 27-June 4, 2019 and the company received four Form 483 observations, Indoco Remedies said in a filing to BSE.
NEW DELHI: Drug firm Indoco Remedies on Friday said it has received establishment inspection report from the US health regulator for its sterile facility and solid dosages facility in Goa. The inspection was held from May 27-June 4, 2019 and the company received four Form 483 observations, Indoco Remedies said in a filing to BSE.
"We are happy to receive the EIR in less than two months from the date of inspection," Indoco Remedies MD Aditi Kare Panandikar said.
This is encouraging, as the site has been endorsed with the Voluntary Action Indicated (VAl) status twice this year, by the United States Food and Drug Administration (USFDA), she added.
Read Also: Indoco Remedies gets USFDA warning letter for significant violations at Goa facility
"The recent inspection was a pre-approval inspection for 3 abbreviated new drug applications (ANDAs) of injectable products filed through our partners," Aditi said.
The company has 33 ANDAs pending for approval, out of which, 17 are for ophthalmics, 5 are for injectables and 11 are for solid dosages from the site, Indoco Remedies said.
Read Also: USFDA issues warning letter to Indoco Remedies for Goa plant
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