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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | Aurobindo Pharma Limited |
India |
APITORIA PHARMA PRIVATE LTD | 27106 | PITAVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE) | 2013-05-07 | Active | II | Complete | 2013-09-14 | 2013-05-07 |
| 31/10/2025 | Fuxin Long Rui Pharmaceutical |
China |
FUXIN LONG RUI PHARMACEUTICAL CO LTD | 33489 | PITAVASTATIN CALCIUM | 2019-05-30 | Active | II | N/A |
