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    Sapropterin Dihydrochloride

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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
    28/03/2025 Biophore India Pharmaceuticals Pvt Ltd
    India
    		 BIOPHORE INDIA PHARMACEUTICALS PVT LTD 36147 SAPROPTERIN DIHYDROCHLORIDE 2021-07-31 Active II Complete 2021-10-18 2021-09-28
    28/03/2025 Asymchem Laboratories
    China
    		 ASYMCHEM LABORATORIES TIANJIN CO LTD 28416 SAPROPTERIN 2014-06-20 Active II N/A