Certain excipients have been exclusively developed for a few drug formulations that would go off-patent in the coming years. These excipients are Type IV DMF filed with USFDA & CHINA NMPA to aid to the NDA / ANDA filing planned by the drug formulators.
| Drug Formulation | Excipient offered by Actylis | Regulatory Status/Grade |
|---|---|---|
|
Amphoterecin B |
di-Sodium succinate hexahydrate HP |
USDMF, CDMF |
|
Bendamustine |
tert-Butanol HP |
USDMF, CDMF |
|
Acetonitrile HP |
USDMF, CDMF |
|
|
Acetone |
USP-NF, Ph.Eur, BP, CDMF |
|
|
Bortezomib |
Acetonitrile HP |
USDMF, CDMF |
|
tert-Butanol HP |
USDMF, CDMF |
|
|
Buprenorphine patch |
Levulinic acid |
USDMF, CDMF |
|
Busalfan |
N,N-Dimethyl acetamide HP |
USDMF, Ph.Eur, CDMF |
|
PEG 400 |
USP, Ph.Eur |
|
|
Carmustine |
tert-Butanol HP |
USDMF, CDMF |
|
Cisatracurium besilate (Nimbex) |
Benzene sulphonic acid HP |
USDMF, CDMF |
|
Cyclophosphamide |
tert-Butanol HP |
USDMF, CDMF |
|
Decitabine |
Acetonitrile HP |
USDMF, CDMF |
|
Dihydroergotamine |
Methane sulphonic acid HP |
USDMF, CDMF |
|
Dimethyl fumarate |
Fumaric acid |
CDMF |
|
Doxorubicin |
tert-Butanol HP |
USDMF, CDMF |
|
Gadopentate dimeglumine |
Diethylene triamine pentaacetic acid (Pentetic acid) |
USP |
|
Octreotide acetate |
n-Heptane HP |
USDMF |
|
Octreotide capsule |
Sodium caprate |
Excipient Grade |
|
Para-Effervescent tablets (Paracetamol) |
Monosodium glycine carbonate |
USDMF |
|
Teriparatide |
meta-Cresol |
USP, Ph.Eur, BP, CDMF |
**DMF under filing
*API ingredient
