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The United States Food and Drug Administration (USFDA) inspected the Unit III, Limbasi Sojitra Road, Taluka- Matar, Kheda, Gujarat manufacturing facility from 26 June 2023 to 30 June 2023.
The company received the establishment inspection report (EIR) indicating closure of inspection and classifying the facility as ‘no action indicated' (NAI).
The company stated that based on this inspection and the USFDA NAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP).
Concord is an India-based R&D-driven biopharma company. The company is ranked among the leading global developers and manufacturers of select fermentation-based active pharmaceutical ingredients (API) across immunosuppressants and oncology in terms of market share, based on volume in 2022.
Shares of Concord Biotech debuted on the bourses on 18 August 2023. The scrip was listed at Rs 900.05, representing a 22.31% premium to the issue price of Rs 741.
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