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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 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 35576 | TENELIGLIPTIN HYDROBROMIDE HYDRATE | 2021-03-29 | Active | II | N/A | ||
| 31/10/2025 | Metrochem API Private Limited |
India |
METROCHEM API PRIVATE LTD | 39822 | TENELIGLIPTIN HYDROCHLORIDE HYDRATE | 2024-04-13 | Active | II | N/A |
