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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

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    Onglyza Hydrate

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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
    28/11/2024 TAPI Technology & API Services
    Israel
    		 TEVA PHARMACEUTICAL INDUSTRIES LTD 27174 SAXAGLIPTIN MONOHYDRATE 2013-06-27 Active II Complete 2013-09-13 2013-06-17
    28/11/2024 Aurobindo Pharma Limited
    India
    		 APITORIA PHARMA PRIVATE LTD 27111 SAXAGLIPTIN MONOHYDRATE (NON-STERILE DRUG SUBSTANCE) 2013-05-09 Active II Complete 2013-09-16 2013-05-07