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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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Injectables

Add / Remove Product
Code
Product
Dosage Form
Strengths
EUGMP Facility
BE Study
Details

Ready CTD Dossiers

AII00

AII01

AIG00

CII00

CII04

CII05

CIG00

CIG01

DIS10

DIC10

EIG00

HIS10

LIC10

LIS10

MIS10

OIG00

PIC10

RIG00

TIG00

TIG01

TIS10

VIG00

Amoxicillin Clavulanic Acid

Ampicillin

Azithromycin

Cefazolin Sodium

Ceftriaxone Sodium

Cefuroxime Sodium

Clarithromycin

Colistimethate

Dexamethasone Sodium Phosphate

Diclofenac Sodium

Esomeprazole

Hydrocortisone Sodium Succinate

Lidocaine (Preservative free)

Lidocaine (with preservative)

Methylprednisolone Sodium Succinate

Omeprazole

Pantoprazole

Rifampicin

Teicoplanin

Tigecycline

Tranexamic Acid

Vancomycin

Powder for Inj.

Powder for Inj.

Powder for Inj.

Powder for Inj.

Powder for Inj.

Powder for Inj.

Powder for Inj.

Powder for Inj.

Liquid Inj.

Liquid Inj.

Powder for Inj.

Powder for Inj.

Liquid Inj.

Liquid Inj.

Powder for Inj.

Powder for Inj.

Powder for Inj.

Powder for Inj.

Powder for Inj.

Powder for Inj.

Liquid Inj.

Powder for Inj.

600 mg, 1.2 g

500 mg, 1g

500 mg

1 g

1 g, 2 g

750 mg, 1.5 g

500 mg

1 MIU, 2 MIU

4 mg/mL

25 mg/mL

40 mg

25 mg, 100 mg, 500 mg, 1 g

1%, 2%

20 mg/mL

20 mg, 40 mg, 125 mg, 500 mg

40 mg

40 mg

300 mg, 600 mg

200 mg, 400 mg

50 mg

500 mg / 5 mL, 1000 mg / 10 mL

500 mg, 1 g

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Nov-25

Yes

Yes

Nov-25

Yes

Yes

Yes

Nov-25

Yes

Yes

Yes

Yes

Yes

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

Selected Products:
Inquire Now

Please select a Product to inquire

Pipeline

AIS10

BII00

BIC10

CIS20

CIS21

CIS10

CIS22

FIS20

KIC10

MIC10

MIS12

PII00

TIC10

OIS20

Atropine

Benzyl Penicillin Sodium

Bupivacaine Hydrochloride

Carfilzomib

Carmustine

Clindamycin

Cytarabine

Fludarabine Phosphate

Ketoprofen

Metoclopramide

Metoprolol

Piperacillin + Tazobactam

Tramadol

Octreotide

Liquid Inj.

Powder for Inj.

Liquid Inj.

Powder for Inj.

Powder for Inj.

Liquid Inj.

Liquid Inj.

Liquid Inj.

Liquid Inj.

Liquid Inj.

Liquid Inj.

Powder for Inj.

Liquid Inj.

Depot Inj.

0.6 mg, 1 mg

0.5 MU, 1 MU, 2 MU, 5 MU

0.5%

60 mg

100 mg

300 mg / 2 mL, 600 mg / 4 mL

100 mg / 1 mL, 500 mg / 5 mL, 1 g / 10 mL, 2 g / 20 mL

50 mg / 2 mL

100 mg / 2 mL

5 mg/mL

1 mg

2.25 g, 4.5 g

50 mg/mL

10 mg, 20 mg, 30 mg

Yes

Yes

Nov-25

Yes

Yes

Yes

Yes

Yes

Nov-25

Nov-25

Yes

Yes

Nov-25

Yes

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

TBD

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
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