Sr. No. |
Product Name |
Therapeutic Category |
DMF |
US DMF |
PMDA |
CADIFA |
CEP/ASMF |
WC |
NMPA |
MFDS |
COFEPRIS |
1 |
Bempedoic Acid |
Lipid Lowering Agent |
Y |
Y |
|
Y |
|
|
Y |
|
|
2 |
Daprodustat |
Anemia with CKD |
Y |
Y |
|
|
|
|
|
|
|
3 |
Finerenone |
Prevention of Kidney Disease |
Y |
Y |
|
|
|
|
|
|
|
4 |
Mirogabalin |
Neuropathic Pain |
Y |
|
|
|
|
|
|
|
|
5 |
Pemafibrate |
Lipid Lowering Agent |
Y |
|
|
|
|
|
|
|
|
6 |
Roxadustat |
Anemia with CKD |
Y |
|
|
|
|
|
|
|
|
7 |
Tegoprazan |
Anti-ulcer |
Y |
|
|
|
|
|
|
Y |
|
8 |
Tegoprazan Benzoate |
Anti-ulcer |
Y |
|
|
|
|
|
|
|
|
9 |
Trelagliptin Succinate |
Anti-diabetic |
Y |
|
|
|
|
|
|
|
|
10 |
Vadadustat |
Anemia with CKD |
Y |
|
|
|
|
|
|
|
|
11 |
Vibegron |
Overactive Bladder |
Y |
|
|
|
|
|
|
|
|
12 |
Vonoprazan Fumarate |
Anti-ulcer |
Y |
Y |
|
|
|
Y |
Y |
Y |
|
APIs with NCE Expired |
Sr. No. |
Product Name |
Therapeutic Category |
DMF |
US DMF |
PMDA |
CADIFA |
CEP/ASMF |
WC |
NMPA |
MFDS |
COFEPRIS |
1 |
Acebrophylline |
Anti-asthmatic/Bronchodilator |
Y |
|
|
|
|
Y |
|
Y |
Y |
2 |
Alpha Lipoic Acid |
Anti-oxidant |
Y |
|
|
|
CEP |
|
|
|
|
3 |
Ambroxol Hydrochloride |
Mucolytic Expectorant |
Y |
|
Y |
|
CEP |
Y |
Y |
Y |
Y |
4 |
Azilsartan Medoxomil Potassium Salt |
Anti-hypertensive |
Y |
|
|
|
|
Y |
Y |
Y |
|
5 |
Benfotiamine |
Vitamin Supplement |
Y |
|
|
|
|
Y |
|
Y |
|
6 |
Benzonatate |
Anti-tussive |
Y |
|
|
|
|
Y |
|
|
|
7 |
Betahistine Dihydrochloride |
Anti-vertigo |
Y |
|
|
Y |
CEP |
Y |
Y |
|
Y |
8 |
Bilastine |
Anti-histaminic |
Y |
|
|
|
|
|
|
|
|
9 |
Bisbentiamine |
Vitamin Supplement |
Y |
|
|
|
|
|
|
Y |
|
10 |
Brivaracetam |
Anti-epileptic |
Y |
Y |
|
|
|
Y |
Y |
|
|
11 |
Choline Fenofibrate |
Lipid Lowering Agent |
Y |
|
|
|
|
Y |
|
Y |
Y |
12 |
Dapagliflozin Amorphous |
Anti-diabetic |
Y |
Y |
|
Y |
|
|
|
|
|
13 |
Dapagliflozin Propandiol Solvate |
Anti-diabetic |
Y |
Y |
|
Y |
|
|
|
|
|
14 |
Dapoxetine Hydrochloride |
Premature Ejaculation |
Y |
|
|
|
|
Y |
Y |
|
Y |
15 |
Desvenlafaxine Succinate |
Anti-depressant |
Y |
Y |
|
|
|
Y |
Y |
Y |
Y |
16 |
Diacerein |
Anti-rheumatic |
Y |
Y |
|
|
CEP |
Y |
Y |
Y |
Y |
17 |
Doxofylline |
Anti-asthmatic/Bronchodilator |
Y |
|
|
|
ASMF |
Y |
Y |
Y |
Y |
18 |
Edoxaban |
Anti-coagulant |
Y |
Y |
|
|
|
|
|
|
|
19 |
Empagliflozin Crystalline |
Anti-diabetic |
Y |
Y |
|
Y |
|
|
|
|
|
20 |
Eslicarbazepine Acetate |
Anti-epileptic |
Y |
Y |
|
|
ASMF |
Y |
Y |
Y |
Y |
21 |
Febuxostat |
Anti-gout |
Y |
Y |
|
|
|
Y |
Y |
Y |
Y |
22 |
Fenofibrate |
Lipid Lowering Agent |
Y |
|
|
|
|
|
|
|
|
23 |
Fexofenadine Hydrochloride |
Anti-histaminic |
Y |
|
|
|
|
|
|
|
|
24 |
Fimasartan Potassium |
Anti-hypertensive |
Y |
|
|
|
|
Y |
|
Y |
|
25 |
Flavoxate Hydrochloride |
Anti-muscarinic |
Y |
|
|
|
|
Y |
|
|
Y |
26 |
Fursultiamine |
Vitamin Supplement |
Y |
|
|
|
|
|
|
|
|
27 |
Gliclazide |
Anti-diabetic |
Y |
|
|
|
CEP |
|
|
|
|
28 |
Imeglimin Hydrochloride |
Anti-diabetic |
Y |
|
|
|
|
|
|
|
|
29 |
Itopride Hydrochloride |
Non-ulcer Dyspepsia |
Y |
|
|
|
ASMF |
Y |
Y |
Y |
Y |
30 |
Levocloperastine Fendizoate |
Anti-tussive |
Y |
|
|
|
|
Y |
|
|
|
31 |
Mirabegron |
Urinary Infrequency |
Y |
|
|
|
|
|
|
|
|
32 |
Oxcarbazepine |
Anti-epileptic |
Y |
Y |
|
|
CEP |
|
|
|
|
33 |
Pamabrom |
Diuretic |
Y |
|
|
|
|
Y |
|
|
Y |
34 |
Rivaroxaban |
Anti-coagulant |
Y |
Y |
|
|
CEP |
|
|
|
|
35 |
Sacubitril Calcium |
Anti-hypertensive/Heart Failure |
|
|
|
|
|
|
|
|
|
36 |
Sacubitril Sodium |
Anti-hypertensive/Heart Failure |
Y |
Y |
|
|
|
|
|
|
|
37 |
Sacubitril Valsartan Trisodium Pentahemihydrate |
Anti-hypertensive/Heart Failure |
Y |
Y |
|
|
|
Y |
Y |
Y |
|
38 |
Sevelamer Carbonate |
Anti-hyperphosphatemic |
Y |
Y |
|
|
|
Y |
Y |
|
|
39 |
Sevelamer Hydrochloride |
Anti-hyperphosphatemic |
Y |
Y |
|
|
|
Y |
|
|
|
40 |
Sitagliptin Hydrochloride |
Anti-diabetic |
Y |
|
|
|
|
|
|
|
|
41 |
Sitagliptin Phosphate Anhydrous |
Anti-diabetic |
Y |
|
|
|
|
|
|
|
|
42 |
Sitagliptin Phosphate Monohydrate |
Anti-diabetic |
Y |
Y |
|
|
CEP |
|
|
|
|
43 |
Tadalafil |
Erectile Dysfunction |
Y |
Y |
|
|
CEP |
Y |
Y |
Y |
Y |
44 |
Tapentadol Hydrochloride |
Analgesic |
Y |
|
|
|
CEP |
Y |
Y |
Y |
|
45 |
Tapentadol Phosphate |
Analgesic |
Y |
|
|
|
|
|
|
|
|
46 |
Teneligliptin Hydrobromide Hydrate |
Anti-diabetic |
Y |
|
|
|
|
Y |
Y |
Y |
|
47 |
Tranexamic Acid |
Anti-fibrinolytic |
Y |
Y |
|
|
CEP |
Y |
Y |
|
Y |
48 |
Vildagliptin |
Anti-diabetic |
Y |
|
Y |
Y |
|
Y |
Y |
Y |
|
49 |
Xanthinol Nicotinate |
Vasodilator |
Y |
|
|
|
|
|
|
|
|