APIs

Active Pharmaceutical Ingredients List

Plant I

S. No. Product Name GMP DMF USDMF CEP
1 Erythromycin Base PIC/S, USFDA, EUGMP      
2 Erythromycin Base Dihydrate PIC/S, USFDA, EUGMP      
3 Erythromycin Estolate PIC/S, EUGMP ASMF ⸻ ⸻
4 Erythromycin Ethyl Succinate PIC/S, USFDA, EUGMP      
5 Erythromycin Stearate PIC/S, USFDA, EUGMP      
6 Clarithromycin PIC/S, EUGMP   ⸻  
7 Azithromycin Dihydrate PIC/S – NPRA   ⸻ Submitted Jan 2024
8 Azithromycin Coated Granules PIC/S – NPRA   ⸻ ⸻
9 Clarithromycin Coated Granules 27.5%, 33% & 42% PIC/S – NPRA   ⸻ ⸻

Plant II

S. No. Product Name GMP DMF USDMF CEP
10 Erythromycin Lactobionate PIC/S – NPRA   ⸻ ⸻
11 Deferasirox PIC/S – NPRA   ⸻ Submitted March 2024
12 Cinacalcet Hydrochloride PIC/S – NPRA   ⸻ ⸻
13 Dexamethasone Sodium Phosphate PIC/S – NPRA   ⸻ Submitted Jan 2024
14 Betamethasone Valerate PIC/S – NPRA   ⸻  
15 Betamethasone Sodium Phosphate PIC/S – NPRA   ⸻ Submitted Oct 2024
16 Betamethasone Dipropionate PIC/S – NPRA   ⸻ ⸻
17 Fluocinolone Acetonide PIC/S – NPRA   ⸻ ⸻