Injectables

Pipeline

Code	Product	Dosage Form	Strength	EUGMP Facility	CTD Dossier	CTD Dossier
CTS30	Cyclophosphamide	Tablets	50 mg	Yes	2027	2027
ETS30	Enzalutamide	Tablets	160 mg	Yes	2027	2027
FMM00	Fampridine	PR Tablets	10 mg	Yes	2027	2027
FTS30	Fludarabine Phosphate	Tablets	10 mg	Yes	2027	2027
IGM00	Ivacaftor	Sachets / Granules	25 mg, 50 mg, 75 mg	Yes	2027	2027
MMM00	Mirabegron	PR Tablets	25 mg, 50 mg	Yes	Q3 2026	Q3 2026
NMM02	Naproxen + Esomeprazole	MR Tablets	375/20 mg, 500/20 mg	Yes	Q4 2026	Q4 2026
OTS30	Olaparib	Tablets	100 mg, 150 mg	Yes	2027	2027
OCS30	Olaparib	Capsules	50 mg	Yes	2027	2027
PMM00	Paliperidone	ER Tablets	1.5 mg, 3 mg, 6 mg, 9 mg ,12 mg	Yes	Q4 2026	Q4 2026
PTM00	Perindopril Arginine + Amlodipine	Tablets	3.5/2.5 mg, 7/5 mg, 14/10 mg	Yes	Q4 2026	Q4 2026
STM00	Sacubitril + Valsartan	Tablets	24/26 mg, 49/51 mg, 97/103 mg	Yes	Q3 2026	Q3 2026
SMM00	Solifenacin + Tamsulosin	MR Tablets	6/0.4 mg	Yes	2027	2027
VTM00	Vortioxetine	Tablets	5 mg, 10 mg, 15 mg, 20 mg	Yes	Q4 2026	Q4 2026
ZTM00	Zofenopril	Tablets	4.5 mg, 15 mg, 30 mg, 60 mg	Yes	2027	2027

Add / Remove Product

Code

Product

Dosage Form

Strengths

EUGMP Facility

CTD Dossier

EU/UK CPP

Details

Ready CTD Dossiers

AII00

AII01

AIS30

CIS33

CIS30

CII00

CII04

CII05

CIS32

DIS10

DIC10

DIS30

DIS31

FIS30

FIS31

HIS10

LIC10

LIS10

MIS30

MIS10

PIC10

TIC10

TIS10

VIS30

Amoxicillin Clavulanic Acid

Ampicillin

Azacitidine

Cabazitaxel

Carfilzomib

Cefazolin Sodium

Ceftriaxone Sodium

Cefuroxime Sodium

Cytarabine

Dexamethasone Sodium Phosphate

Diclofenac Sodium

Docetaxel

Doxorubicin Liposomal

Fludarabine Phosphate

Fulvestrant

Hydrocortisone Sodium Succinate

Lidocaine (Preservative free)

Lidocaine (with preservative)

Methotrexate

Methylprednisolone Sodium Succinate

Pantoprazole

Tramadol

Tranexamic Acid

Vincristine

Powder for Inj.

Soln for Infusion

Powder for Inj.

Liquid Inj.

Soln for Infusion

Liquid Inj.

Powder for Inj.

Liquid Inj.

Soln for Infusion

Powder for Inj.

Liquid Inj.

600 mg, 1200 mg

500 mg, 1000 mg

100 mg

60 mg / 1.5 mL

60 mg

1000 mg

1000 mg, 2000 mg

750 mg, 1500 mg

100 mg / 1 mL, 500 mg / 5 mL, 1000 mg / 10 mL, 2000 mg / 20 mL

4 mg/mL

25 mg/mL

20 mg/mL, 40mg/mL, 80 mg / 2 mL, 120 mg / 3 mL, 160 mg / 8 mL

20 mg / 10 mL, 50 mg / 25 mL

50 mg / 2 mL

250 mg / 5 mL

25 mg, 100 mg, 500 mg, 1000 mg

1%, 2%

20 mg/mL

15 mg / 3 mL, 50 mg / 2 mL, 100 mg / 4 mL, 500 mg / 20 mL, 1000 mg / 40 mL

20 mg, 40 mg, 125 mg, 500 mg

40 mg

50 mg/mL

500 mg / 5 mL, 1000 mg / 10 mL

1 mg / 1 mL, 2 mg / 2 mL, 5 mg / 5 mL

Yes

EU CPP

Inquire Now

Selected Products:

Please select a Product to inquire

Pipeline

AIS10

BIC10

CIS31

CIS10

CIW00

KIS10

KIC10

MIC10

OIS30

TIS30

VIW00

Atropine

Bupivacaine Hydrochloride

Carmustine

Clindamycin

Colistimethate

Ketorolac Tromethamine

Ketoprofen

Metoclopramide

Octreotide

Trabectedin

Vancomycin

Liquid Inj.

Powder for Inj.

Liquid Inj.

Powder for Inj.

Liquid Inj.

Depot Inj.

Soln for Infusion

Powder for Inj.

0.6 mg, 1 mg

0.25 mg/mL, 0.5mg/mL

100 mg

300 mg / 2 mL, 600 mg / 4 mL

1 MIU, 2 MIU

30 mg/mL

100 mg / 2 mL

5 mg/mL

10 mg, 20 mg, 30 mg

0.25 mg, 1 mg

500 mg, 1000 mg

Yes

Jun-26

Yes

Jun-26

2027

Q3 2026

Q4 2026

2027

Q4 2026

Q3 2026

2027

Q4 2026

Back to Products

Ready CTD Dossiers

Code	Product	Dosage Form	Strength	EUGMP Facility	CTD Dossier
ATM03	Amitriptyline	Tablets	10 mg, 25 mg, 50 mg	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
ATM00	Amoxicillin Clavulanic Acid	Tablets	250/125 mg, 500/125 mg, 875/125 mg, 500/62.5 mg, 1000/125 mg	Yes	Yes
ATM02	Apixaban	FC Tablets	2.5 mg, 5 mg	Yes	Yes
ATM01	Atorvastatin + Ezetimibe	Tablets	10/10 mg, 20/10 mg, 40/10 mg, 80/10 mg	Yes	Yes
BTM00	Bilastine	Tablets	20 mg	Yes	Yes
CTM00	Clarithromycin	Tablets	250 mg, 500 mg	Yes	Yes
CTM01	Clopidogrel	Tablets	75 mg	Yes	Yes
DTM00	Dapagliflozin	FC Tablets	5 mg, 10 mg	Yes	Yes
DGE00	Diclofenac Potassium	Sachets	50 mg	Yes	Yes
ETM00	Edoxaban	Tablets	15 mg, 30 mg, 60 mg	Yes	Yes
ETM01	Empagliflozin	Tablets	10 mg, 25 mg	Yes	Yes
EMP00	Esomeprazole	Capsules	20 mg, 40 mg	Yes	Yes
EML00	Esomeprazole	GR Tablets	20 mg, 40 mg	Yes	Yes
ITM00	Ibuprofen	Tablets	200 mg, 400 mg, 600 mg	Yes	Yes
LTL00	Linezolid	Tablets	600 mg	Yes	Yes
LCM00	Loperamide	Capsules	2 mg	Yes	Yes
NCB00	Nilotinib	Capsules	150 mg, 200 mg	Yes	Yes
NCM00	Nitrofurantoin	Capsules	50 mg, 100 mg	Yes	Yes
NMM01	Nitrofurantoin	PR Capsules	100 mg	Yes	Yes
PTS00	Paracetamol	Tablets	500 mg	Yes	Yes
PTM01	Phenytoin	Tablets	25 mg, 50 mg, 100 mg	Yes	Yes
PTM02	Primidone	Tablets	50 mg, 125 mg, 250 mg, 500 mg	Yes	Yes
RTW10	Riociguat	Tablets	0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg	Pending	Yes
RTM00	Rivaroxaban	FC Tablets	10 mg, 15 mg, 20 mg	Yes	Yes
STX00	Sevelamer Carbonate	Tablets	800 mg	Yes	Yes
STL01	Sitagliptin Phosphate Monohydrate + Metformin HCl	Tablets	50/500 mg, 50/850 mg, 50/1000 mg	Yes	Yes
STL00	Sitagliptin Phosphate Monohydrate	Tablets	25 mg, 50 mg, 100 mg	Yes	Yes
TTM00	Ticagrelor	FC Tablets	60 mg, 90 mg	Yes	Yes
VTL01	Vildagliptin	Tablets	50 mg	Yes	Yes
VTL02	Vildagliptin + Metformin	Tablets	50/500 mg, 50/850 mg, 50/1000 mg	Yes	Yes