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Oral Solids, Semi-Solids & Liquids
ACR00
ALM00
ATM00
ATM02
ATM01
CTR00
CTR01
CCR00
CTR02
DMR00
DTM00
DGE00
EMP00
EML00
FTR00
HTR00
ITM00
LTR00
LTL00
MTR00
MTL00
NMM00
NTR00
NTR01
NCB00
NCM00
NMM01
PTS00
RTM00
STX00
STL01
STL00
TTR00
TTR01
VTL01
VTL02
Amantadine Hydrochloride
Amoxicillin Clavulanic Acid
Amoxicillin Clavulanic Acid
Apixaban
Atorvastatin + Ezetimibe
Cabergoline
Carbimazole
Clindamycin
Colchicine
Diprymadole
Dapagliflozin
Diclofenac Potassium
Esomeprazole
Esomeprazole
Fludrocortisone Acetate
Hydrocortisone
Ibuprofen
Levothyroxine Sodium
Linezolid
Macitentan
Moxifloxacin
Naproxen
Naratriptan Hydrochloride
Nefopam Hydrochloride
Nilotinib
Nitrofurantoin
Nitrofurantoin
Paracetamol
Rivaroxaban
Sevelamer Carbonate
Sitagliptin Phosphate Monohydrate + Metformin HCl
Sitagliptin Phosphate Monohydrate
Tadalafil
Ticagrelor
Vildagliptin
Vildagliptin + Metformin
Capsules
Suspension/Sachet
Tablets
FC Tablets
Tablets
Tablets
Tablets
Capsules
Tablets
PR Capsules
FC Tablets
Sachets
Capsules
GR Tablets
Tablets
Tablets
Tablets
Tablets
Tablets
FC Tablets
Tablets
EC Tablets
FC Tablets
FC Tablets
Capsules
Capsules
PR Capsules
Tablets
FC Tablets
Tablets
Tablets
Tablets
FC Tablets
FC Tablets
Tablets
Tablets
100 mg
125/31.25 mg, 250/62.5 mg, 200/28.5 mg, 400/57 mg
250/125 mg, 500/125 mg, 875/125 mg, 500/62.5 mg, 1000/125 mg
2.5 mg, 5 mg
10/10 mg, 20/10 mg, 40/10 mg, 80/10 mg
0.5 mg, 1 mg, 2 mg
5 mg, 20 mg
75 mg, 150 mg, 300 mg
500 mcg
200 mg
5 mg, 10 mg
50 mg
20 mg, 40 mg
20 mg, 40 mg
100 mcg
5 mg, 10 mg, 20 mg
200 mg, 400 mg, 600 mg
25 mcg, 50 mcg, 75 mcg
600 mg
10 mg
400 mg
250 mg, 375 mg, 500 mg
2.5 mg
30 mg
150 mg, 200 mg
50 mg, 100 mg
100 mg
500 mg
10 mg, 15 mg, 20 mg
800 mg
50/500 mg, 50/850 mg, 50/1000 mg
25 mg, 50 mg, 100 mg
5 mg, 20 mg
60 mg, 90 mg
50 mg
50/500 mg, 50/850 mg, 50/1000 mg
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Biowaiver
Yes
Yes
Yes
Yes
Yes
Yes
Biowaiver
Yes
Biowaiver
Yes
Yes
Yes
Yes
Yes
Yes
Biowaiver
Yes
Yes
Yes
Biowaiver
Yes
Yes
Biowaiver
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Selected Products:
Please select a Product to inquire
Add / Remove Product
Code
Product
Dosage Form
Strengths
EUGMP Facility
BE Study
EU CPP
Details
Ready CTD Dossiers
Pipeline
CTS20
ETS20
FTS20
NMM02
OTS20
OCS20
STM00
Cyclophosphamide
Enzalutamide
Fludarabine Phosphate
Naproxen + Esomeprazole
Olaparib
Olaparib
Sacubitril Valsartan
Tablets
Tablets
Tablets
MR Tablets
Tablets
Capsules
Tablets
50 mg
160 mg
10 mg
375/20 mg, 500/20 mg
100 mg, 150 mg
50 mg
24/26 mg, 49/51 mg, 97/103 mg
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Pending
Pending
Pending
Pending
Pending
Pending
Pending
Ready CTD Dossiers
Code | Product | Dosage Form | Strength | EUGMP Facility | CTD Dossier | BE Study |
|---|---|---|---|---|---|---|
ACR00 | Amantadine Hydrochloride | Capsules | 100 mg | Yes | Yes | Yes |
ALM00 | Amoxicillin Clavulanic Acid | Suspension/Sachet | 125/31.25 mg, 250/62.5 mg, 200/28.5 mg, 400/57 mg | Yes | Yes | Yes |
ATM00 | Amoxicillin Clavulanic Acid | Tablets | 250/125 mg, 500/125 mg, 875/125 mg, 500/62.5 mg, 1000/125 mg | Yes | Yes | Yes |
ATM02 | Apixaban | FC Tablets | 2.5 mg, 5 mg | Yes | Yes | Yes |
ATM01 | Atorvastatin + Ezetimibe | Tablets | 10/10 mg, 20/10 mg, 40/10 mg, 80/10 mg | Yes | Yes | Yes |
CTR00 | Cabergoline | Tablets | 0.5 mg, 1 mg, 2 mg | Yes | Yes | Yes |
CTR01 | Carbimazole | Tablets | 5 mg, 20 mg | Yes | Yes | Yes |
CCR00 | Clindamycin | Capsules | 75 mg, 150 mg, 300 mg | Yes | Yes | Yes |
CTR02 | Colchicine | Tablets | 500 mcg | Yes | Yes | Yes |
DMR00 | Diprymadole | PR Capsules | 200 mg | Yes | Yes | Yes |
DTM00 | Dapagliflozin | FC Tablets | 5 mg, 10 mg | Yes | Yes | Yes |
DGE00 | Diclofenac Potassium | Sachets | 50 mg | Yes | Yes | Biowaiver |
EMP00 | Esomeprazole | Capsules | 20 mg, 40 mg | Yes | Yes | Yes |
EML00 | Esomeprazole | GR Tablets | 20 mg, 40 mg | Yes | Yes | Yes |
FTR00 | Fludrocortisone Acetate | Tablets | 100 mcg | Yes | Yes | Yes |
HTR00 | Hydrocortisone | Tablets | 5 mg, 10 mg, 20 mg | Yes | Yes | Yes |
ITM00 | Ibuprofen | Tablets | 200 mg, 400 mg, 600 mg | Yes | Yes | Yes |
LTR00 | Levothyroxine Sodium | Tablets | 25 mcg, 50 mcg, 75 mcg | Yes | Yes | Yes |
LTL00 | Linezolid | Tablets | 600 mg | Yes | Yes | Biowaiver |
MTR00 | Macitentan | FC Tablets | 10 mg | Yes | Yes | Yes |
MTL00 | Moxifloxacin | Tablets | 400 mg | Yes | Yes | Biowaiver |
NMM00 | Naproxen | EC Tablets | 250 mg, 375 mg, 500 mg | Yes | Yes | Yes |
NTR00 | Naratriptan Hydrochloride | FC Tablets | 2.5 mg | Yes | Yes | Yes |
NTR01 | Nefopam Hydrochloride | FC Tablets | 30 mg | Yes | Yes | Yes |
NCB00 | Nilotinib | Capsules | 150 mg, 200 mg | Yes | Yes | Yes |
NCM00 | Nitrofurantoin | Capsules | 50 mg, 100 mg | Yes | Yes | Yes |
NMM01 | Nitrofurantoin | PR Capsules | 100 mg | Yes | Yes | Yes |
PTS00 | Paracetamol | Tablets | 500 mg | Yes | Yes | Biowaiver |
RTM00 | Rivaroxaban | FC Tablets | 10 mg, 15 mg, 20 mg | Yes | Yes | Yes |
STX00 | Sevelamer Carbonate | Tablets | 800 mg | Yes | Yes | Yes |
STL01 | Sitagliptin Phosphate Monohydrate + Metformin HCl | Tablets | 50/500 mg, 50/850 mg, 50/1000 mg | Yes | Yes | Yes |
STL00 | Sitagliptin Phosphate Monohydrate | Tablets | 25 mg, 50 mg, 100 mg | Yes | Yes | Biowaiver |
TTR00 | Tadalafil | FC Tablets | 5 mg, 20 mg | Yes | Yes | Yes |
TTR01 | Ticagrelor | FC Tablets | 60 mg, 90 mg | Yes | Yes | Yes |
VTL01 | Vildagliptin | Tablets | 50 mg | Yes | Yes | Biowaiver |
VTL02 | Vildagliptin + Metformin | Tablets | 50/500 mg, 50/850 mg, 50/1000 mg | Yes | Yes | Yes |
Pipeline
Code | Product | Dosage Form | Strength | EUGMP Facility | CTD Dossier | CTD Dossier |
|---|---|---|---|---|---|---|
CTS20 | Cyclophosphamide | Tablets | 50 mg | Yes | TBD | TBD |
ETS20 | Enzalutamide | Tablets | 160 mg | Yes | TBD | TBD |
FTS20 | Fludarabine Phosphate | Tablets | 10 mg | Yes | TBD | TBD |
NMM02 | Naproxen + Esomeprazole | MR Tablets | 375/20 mg, 500/20 mg | Yes | Q4 2026 | Q4 2026 |
OTS20 | Olaparib | Tablets | 100 mg, 150 mg | Yes | TBD | TBD |
OCS20 | Olaparib | Capsules | 50 mg | Yes | TBD | TBD |
STM00 | Sacubitril Valsartan | Tablets | 24/26 mg, 49/51 mg, 97/103 mg | Yes | Q3 2026 | Q3 2026 |
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