Active Pharmaceutical Ingredients (APIs)
Plant I
| S. No. | Product Name | Structure | GMP | Documentation |
|---|---|---|---|---|
| 1 | Erythromycin base CAS No. [114-07-8] |
 Chemical Formula: C37H67NO13 Molecular Weight: 733.93 |
PIC/S, USFDA, EUGMP | DMF, USDMF, CEP |
| 2 | Erythromycin base dihydrate CAS No. [59319-72-1] |
 Chemical Formula: C37H71NO15 Molecular Weight: 769.96 |
PIC/S, USFDA, EUGMP | DMF, USDMF, CEP |
| 3 | Erythromycin Estolate CAS No. [3521-62-8] |
 Chemical Formula: C52H97NO18S Molecular Weight: 1056.39 |
PIC/S, EUGMP | DMF |
| 4 | Erythromycin ethyl succinate CAS No. [1264-62-6] |
 Chemical Formula: C43H75NO16 Molecular Weight: 862.05 |
PIC/S, USFDA, EUGMP | DMF, USDMF, CEP |
| 5 | Erythromycin Stearate CAS No. [643-22-1] |
 Chemical Formula: C55H103NO15 Molecular Weight: 1018.40 |
PIC/S, USFDA, EUGMP | DMF, USDMF, CEP |
| 6 | Clarithromycin CAS No. [81103-11-9] |
 Chemical Formula: C38H67NO13 Molecular Weight: 747.95 |
PIC/S, EUGMP | DMF, CEP |
| 7 | Azithromycin dihydrate CAS No. [117772-70-0] |
 Chemical Formula: C37H74N2O14 Molecular Weight: 770.99 |
PIC/S, EUGMP | DMF, CEP |
| 8 | Azithromycin Coated Granules | ⸻ | PIC/S – NPRA | DMF |
| 9 | Clarithromycin coated granules (27.5%, 33% & 42%) |
⸻ | PIC/S – NPRA | DMF |
Plant II
| S. No. | Product Name | Structure | GMP | Documentation |
|---|---|---|---|---|
| 10 | Erythromycin Lactobionate CAS No. [3847-29-8] |
 Chemical Formula: C49H89NO25 Molecular Weight: 1092.22 |
PIC/S – NPRA | DMF |
| 11 | Deferasirox CAS No. [201530-41-8] |
 Chemical Formula: C21H15N3O4 Molecular Weight: 373.36 |
PIC/S – NPRA | DMF |
| 12 | Quetiapine fumarate CAS No. [111974-72-2] |
 Chemical Formula: C25H29N3O6S Molecular Weight: 499.58 |
PIC/S – NPRA | DMF |
| 13 | Cinacalcet Hydrochloride CAS No. [364782-34-3] |
 Chemical Formula: C22H23CIF3N Molecular Weight: 393.87 |
PIC/S – NPRA | DMF |
| 14 | Lisdexamfetamine dimesylate CAS No. [608137-33-3] |
 Chemical Formula: C17H33N3O7S2 Molecular Weight: 455.59 |
PIC/S – NPRA | DMF |
| 15 | Dexamethasone sodium Phosphate CAS No. [2392-39-4] |
 Chemical Formula: C22H28FNa2O8P Molecular Weight: 516.40 |
PIC/S – NPRA | DMF |
| 16 | Betamethasone 17-Valerate CAS No. [2152-44-5] |
 Chemical Formula: C27H37FO6 Molecular Weight: 476.58 |
PIC/S – NPRA | DMF, CEP |
| 17 | Betamethasone Sodium Phosphate CAS No. [151-73-5] |
 Chemical Formula: C22H28FNa2O8P Molecular Weight: 516.40 |
PIC/S – NPRA | DMF |
| 18 | Betamethasone dipropionate CAS No. [5593-20-4] |
 Chemical Formula: C28H37FO7 Molecular Weight: 504.59 |
PIC/S – NPRA | DMF |
| 19 | Fluocinolone acetonide CAS No. [67-73-2] |
 Chemical Formula: C24H30F2O6 Molecular Weight: 452.49 |
PIC/S – NPRA | DMF |
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