| Sr. No. |
API Name |
DMF |
USDMF |
PMDA |
CADIFA |
CEP/ASMF |
NMPA |
MFDS |
COFEPRIS |
Indication |
| 1 |
Acebrophylline |
Y |
|
|
Y |
|
|
Y |
Y |
Anti-asthmatic / Bronchodilator |
| 2 |
Ambroxol Hydrochloride |
Y |
|
Y |
|
Y |
Y |
Y |
Y |
Mucolytic Expectorant |
| 3 |
Azilsartan Medoxomil Potassium Salt |
Y |
|
|
|
|
|
Y |
|
Anti-hypertensive |
| 4 |
Bempedoic Acid |
Y |
Y |
|
|
|
Y |
|
|
Lipid Lowering Agent |
| 5 |
Benfotiamine |
Y |
|
|
|
|
|
Y |
|
Vitamin Supplement |
| 6 |
Benserazide |
U |
|
|
|
|
|
|
|
Parkinson's Disease |
| 7 |
Benzonatate |
Y |
Y |
|
|
|
|
|
|
Anti-tussive |
| 8 |
Betahistine Dihydrochloride |
Y |
|
|
Y |
Y |
Y |
Y |
Y |
Anti-vertigo |
| 9 |
Bilastine |
Y |
|
|
|
ASMF |
|
|
|
Anti-histaminic |
| 10 |
Bisbentiamine |
Y |
|
|
|
|
|
Y |
|
Vitamin Supplement |
| 11 |
Brivaracetam |
Y |
Y |
|
Y |
CEP / ASMF |
|
Y |
|
Anti-epileptic |
| 12 |
Choline Fenofibrate |
Y |
|
|
|
|
|
Y |
Y |
Lipid Lowering Agent |
| 13 |
Colesevelam Hydrochloride |
Y |
|
|
|
|
|
|
|
Lipid Lowering Agent |
| 14 |
Dapagliflozin Amorphous |
Y |
Y |
|
|
Y |
|
|
|
Anti-diabetic |
| 15 |
Dapagliflozin Propandiol Solvate |
Y |
Y |
|
|
Y |
|
Y |
|
Anti-diabetic |
| 16 |
Dapoxetine Hydrochloride |
Y |
|
|
|
|
Y |
Y |
Y |
Premature Ejaculation |
| 17 |
Daprodustat |
Y |
Y |
|
|
|
|
|
|
Anemia with CKD |
| 18 |
Desvenlafaxine Succinate |
Y |
Y |
|
Y |
|
|
Y |
Y |
Anti-depressants |
| 19 |
Diacerein |
Y |
Y |
|
|
Y |
Y |
Y |
Y |
Anti-rheumatic |
| 20 |
Dicyclomine Hydrochloride |
Y |
Y |
|
|
Y |
|
|
|
Anti-spasmodic |
| 21 |
Doxofylline |
Y |
|
|
|
ASMF |
Y |
Y |
Y |
Anti-asthmatic / Bronchodilator |
| 22 |
Edoxaban Tosylate |
Y |
Y |
|
|
|
|
Y |
|
Anti-coagulant |
| 23 |
Empagliflozin Crystalline |
Y |
Y |
|
|
|
|
Y |
|
Anti-diabetic |
| 24 |
Eslicarbazepine Acetate |
Y |
Y |
|
|
ASMF |
|
Y |
Y |
Anti-epileptic |
| 25 |
Febuxostat |
Y |
Y |
|
|
|
|
Y |
Y |
Anti-gout |
| 26 |
Fenofibrate |
Y |
|
|
|
|
|
|
|
Lipid Lowering Agent |
| 27 |
Fexofenadine Hydrochloride |
Y |
|
|
|
|
|
|
|
Anti-histaminic |
| 28 |
Fezolinetant |
U |
|
|
|
|
|
|
|
Vasomotor Symptoms due to Menopause |
| 29 |
Fimasartan Potassium |
Y |
|
|
|
|
|
Y |
|
Anti-hypertensive |
| 30 |
Finerenone |
Y |
Y |
|
|
|
|
Y |
|
Prevention of Kidney Disease |
| 31 |
Flavoxate Hydrochloride |
Y |
|
|
|
ASMF |
|
|
Y |
Anti-muscarinic |
| 32 |
Fluvoxamine Maleate |
Y |
|
|
|
|
|
|
|
Obsessive Compulsive Disorder |
| 33 |
Fursultiamine Hydrochloride |
Y |
|
|
|
|
|
Y |
|
Vitamin Supplement |
| 34 |
Gadobutrol |
U |
|
|
|
|
|
|
|
MRI Contrast Agent |
| 35 |
Hydralazine Hydrochloride |
Y |
Y |
|
|
Y |
|
|
|
Anti-hypertensive |
| 36 |
Indapamide |
Y |
|
|
|
|
|
|
|
Anti-hypertensive |
| 37 |
Itopride Hydrochloride |
Y |
|
|
Y |
ASMF |
Y |
Y |
Y |
Non-ulcer Dyspepsia |
| 38 |
Levocloperastine Fendizoate |
Y |
|
|
|
|
|
|
|
Anti-tussive |
| 39 |
Mirabegron |
Y |
Y |
|
|
Y |
|
Y |
|
Urinary Infrequency |
| 40 |
Mirogabalin Besylate |
Y |
Y |
|
|
|
|
Y |
|
Neuropathic Pain |
| 41 |
Oxcarbazepine |
Y |
Y |
|
|
Y |
Y |
|
|
Anti-epileptic |
| 42 |
Pamabrom |
Y |
|
|
|
|
|
|
Y |
Diuretic |
| 43 |
Pemafibrate |
Y |
|
|
|
|
|
|
|
Lipid Lowering Agent |
| 44 |
Resmetirom |
U |
|
|
|
|
|
|
|
Metabolic Dysfunction-associated Steatohepatitis |
| 45 |
Rifampicin |
Y |
|
|
|
|
|
|
|
Anti-tubercular |
| 46 |
Rifapentine |
Y |
|
|
|
|
|
|
|
Anti-tubercular |
| 47 |
Rivaroxaban |
Y |
Y |
|
|
Y |
|
Y |
|
Anti-coagulant |
| 48 |
Roxadustat |
Y |
|
|
|
|
|
|
|
Anemia with CKD |
| 49 |
R-thioctic Acid Tromethamine |
Y |
|
|
|
|
|
Y |
|
Anti-oxidant |
| 50 |
Sacubitril Calcium |
|
|
|
|
|
|
|
|
Anti-hypertensive / Heart Failure |
| 51 |
Sacubitril Sodium |
Y |
Y |
|
|
|
|
|
|
Anti-hypertensive / Heart Failure |
| 52 |
Sacubitril Valsartan Trisodium Pentahemihydrate |
Y |
Y |
|
|
|
|
Y |
|
Anti-hypertensive / Heart Failure |
| 53 |
Salcaprozate Sodium |
Y |
Y |
|
|
|
|
Y |
|
Intestinal Permeability Enhancer |
| 54 |
Sevelamer Carbonate |
Y |
Y |
|
|
|
Y |
Y |
|
Anti-hyperphosphatemia |
| 55 |
Sevelamer Hydrochloride |
Y |
Y |
|
|
|
|
|
|
Anti-hyperphosphatemia |
| 56 |
Sitagliptin Hydrochloride |
Y |
|
|
|
|
|
Y |
|
Anti-diabetic |
| 57 |
Sitagliptin Phosphate Monohydrate |
Y |
Y |
|
|
Y |
|
|
|
Anti-diabetic |
| 58 |
Tadalafil |
Y |
Y |
|
Y |
Y |
Y |
Y |
Y |
Erectile Dysfulction |
| 59 |
Tapentadol Hydrochloride |
Y |
|
|
|
Y |
Y |
|
|
Analgesic |
| 60 |
Tapentadol Phosphate |
Y |
|
|
|
ASMF |
|
|
|
Analgesic |
| 61 |
Tegoprazan Amorphous |
Y |
|
|
|
|
|
Y |
|
Anti-ulcer |
| 62 |
Tegoprazan Crystalline |
Y |
Y |
|
|
|
|
|
|
Anti-ulcer |
| 63 |
Tegoprazan Salicylate |
Y |
|
|
|
|
|
Y |
|
Anti-ulcer |
| 64 |
Teneligliptin Hydrobromide Hydrate |
Y |
|
|
|
|
Y |
Y |
|
Anti-diabetic |
| 65 |
Tolvaptan |
Y |
Y |
|
|
|
|
|
|
Hyponatremia |
| 66 |
Tranexamic Acid |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Y |
Anti-fibrinolytic |
| 67 |
Trelagliptin Succinate |
Y |
|
|
|
|
|
|
|
Anti-diabetic |
| 68 |
Vadadustat |
Y |
Y |
|
|
|
|
Y |
|
Anemia with CKD |
| 69 |
Vibegron |
Y |
Y |
|
|
|
|
Y |
|
Overactive Bladder |
| 70 |
Vildagliptin |
Y |
|
Y |
Y |
|
Y |
Y |
|
Anti-diabetic |
| 71 |
Vonoprazan Fumarate |
Y |
Y |
|
Y |
|
Y |
Y |
|
Anti-ulcer |
| 72 |
Xanthinol Nicotinate |
Y |
|
|
|
|
|
|
|
Vasodilator |