Concord Biotech gets USFDA EIR for Limbasi facility
Ahmedabad: Through a recent BSE filing, Concord Biotech Limited has notified that the Company has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) indicating closure of inspection and classifying the Limbasi (Unit III) facility as "no action indicated" ("NAI").
NAI means no objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action).
USFDA inspected the Company’s Manufacturing Unit III, Plot No. 84 And 668, Ranasar and Malawada, Limbasi Sojitra Road, Near Limbasi, Taluka- Matar, Kheda, Gujarat from Monday, 26th June, 2023 to Friday 30th June, 2023.
Read also: Concord Biotech up 33 percent in debut, nets over USD 1 billion in valuation
Concord Biotech Limited is a R&D driven biopharma Company that manufactures Active Pharmaceutical Ingredients (API) through fermentation & semi-synthetic process and finished formulations. Concord, founded in the 2000, has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord has a presence in more than 70 countries worldwide with efficient distribution infrastructure in markets like the USA, Europe, Japan, Latin America, Africa, Asia, besides significant presence in Indian market. The Company has two API manufacturing units and one finished formulation unit, all located near Ahmedabad, Gujarat, India
Read also: Concord Biotech files IPO papers with SEBI
