U.S. FDA Clears Indoco's Goa Plants, an Industrial Info Market Brief

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India's leading pharmaceutical company, Indoco Remedies Limited, announced it has received an establishment inspection report (EIR) from the U.S. Food and Drug Administration (FDA) for its sterile manufacturing facility (Plant II) and solid dosages facility (Plant III), co-located at Verna Industrial Estate, Goa. The inspection was held from May 27, 2019 through June 04, 2019, wherein the company had received four Form 483 observations, said the company in a news media release.

Indoco has 33 abbreviated new drug applications (ANDAs) pending for approval, out of which 17 are for ophthalmics, five are for injectables and 11 are for solid dosages from the site. Industrial Info is tracking six Indoco manufacturing assets involving oral formulations, topical medication, injectables and active pharmaceutical ingredients (API) units. Industrial Info's database includes 834 pharmaceutical and biotech plant records in India, with 3,533 functional management contacts. Click here for the list of plants, and see map below.