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Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
29/07/2025 Fresenius Kabi AB Brunna
Sweden
FRESENIUS KABI IPSUM SRL 39510 AVIBACTAM SODIUM STERILE 2024-02-09 Active II Complete 2024-02-20 2024-02-08
29/07/2025 Orchid Pharma
India
ORCHID PHARMA LTD 39355 AVIBACTAM SODIUM STERILE 2024-01-23 Active II Complete 2024-03-06 2024-02-23