Product Name | US DMF USFDA |
CEP / ASMF EDQM |
TGA Australia |
COFEPRIS Mexico |
KOREAN FDA |
SFDA China |
WHO-GMP India |
---|---|---|---|---|---|---|---|
Pentosan Polysulfate Sodium | ✓ | ✓ | ✓ | ✓ | |||
Lidocaine Base | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ * | ✓ |
Lidocaine HCI | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Meloxicam | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Melatonin | ✓ | ✓ * | ✓ | ✓ | ✓ | ✓ | |
Granisetron HCI | ✓ | ✓ * | ✓ | ||||
Prilocaine Base | ✓ | ✓ | ✓ | ||||
Prilocaine HCI | ✓ | ✓ * | ✓ | ||||
Tamsulosin | ✓ | ✓ * | ✓ | ||||
Silodosin | ✓ | ✓ | ✓ |
*Application Filed
Glycopyrronium Bromide
Mirabegron
Articaine HCl
Tetracaine Base/HCl
Sr. No. | Product Name | Grade | WHO-GMP/GMP | Written Confirmation | CEP | JDMF/AFM No. | Korea |
---|---|---|---|---|---|---|---|
Steroids | |||||||
1 | Dutasteride | IP/BP/EP/USP | WHO-GMP/GMP | ✓ | Applied | 230MF10161 | ✓ |
2 | Triamcinolone base | IP/BP/EP/USP | WHO-GMP/ GMP | – | – | – | – |
3 | Triamcinolone acetonide | IP/BP/EP/USP | WHO-GMP/ GMP | ✓ | Applied | – | – |
4 | Halobetasol propionate | IP/BP/EP/USP | WHO-GMP/ GMP | Applied | – | – | – |
5 | Fluocinolone acetonide | IP/BP/EP/USP | WHO-GMP/ GMP | ✓ | – | – | – |
6 | Finasteride | IP/BP/EP/USP | WHO-GMP/ GMP | ✓ | – | – | – |
7 | Deflazacort | IH | WHO-GMP/ GMP | – | – | – | – |
Hormones | |||||||
1 | Drospirenone | IP/BP/EP/USP | WHO-GMP/GMP | ✓ | – | – | – |
2 | Desogestrel | EP/BP/USP | WHO-GMP/ GMP | ✓ | – | – | – |
3 | Dienogest | EP/BP/IP | WHO-GMP/ GMP | ✓ | – | – | – |
4 | Ulipristal acetate | IP/IH | WHO-GMP/ GMP | ✓ | – | – | – |
5 | Levonorgestrel | IP/BP/EP/USP | WHO-GMP/ GMP | ✓ | – | – | – |
6 | Norgestrel | IP/BP/EP/USP | WHO-GMP/ GMP | ✓ | – | – | – |
7 | Gestodene | EP/BP | WHO-GMP/ GMP | ✓ | – | – | – |
8 | Estradiol hemihydrate | EP/BP/USP | WHO-GMP/ GMP | ✓ | – | – | – |
9 | Ethinyl Estradiol | EP/BP/USP | WHO-GMP/ GMP | ✓ | – | – | – |
10 | Cyproterone Acetate | IP/BP/EP | WHO-GMP/ GMP | ✓ | – | – | – |
11 | Tibolone | BP/EP | GMP | 2023-24 | – | – | – |
Pipeline | |||||||
1 | Clascoterone | ||||||
2 | Fluticasone Propionate | ||||||
3 | Difluprednate | ||||||
4 | Budesonide | ||||||
5 | Dydrogesterone |