Dosage Form
Sterile Injectable CDMOs
Compare CDMOs manufacturing sterile injectable products for IV, subcutaneous, and intramuscular administration. Filter by container type, aseptic technology, and capacity.
50 companies listed
About Sterile Injectable Manufacturing
Sterile injectable manufacturing produces parenteral products administered by injection. These products bypass the body's natural defense barriers, making sterility the paramount quality attribute. Manufacturing must occur in classified cleanroom environments with validated aseptic processes.
The sterile injectable market is growing faster than overall pharma, driven by biologics (monoclonal antibodies, ADCs, vaccines), complex generics (liposomal formulations, microspheres), and the shift toward self-administered subcutaneous products. CDMOs with modern isolator-based filling lines, lyophilization capability, and multiple container format experience are the most competitive.
Companies (50)
N
NovaPharma B.V.
Netherlands
NovaPharma B.V. is a leading contract development and manufacturing organization headquartered in Netherlands. We specialize in Commercial Manufacturing, Small Molecule API Manufacturer with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
IGS B.V.
Netherlands
IGS B.V. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Osmopharm S.A.
Switzerland
Osmopharm S.A. is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
H
Himachal Polyolefins Ltd
India
Himachal Polyolefins Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
ChemCon GmbH
Germany
ChemCon GmbH is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
AM Instruments
Italy
AM Instruments is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Matrix Fine Chemical
Switzerland
Matrix Fine Chemical is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
Bend Bioscience
United States
Bend Bioscience is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
ABFEN FARMA
Turkey
ABFEN FARMA is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
C
Coriolis Pharma Research GmbH
Germany
Coriolis Pharma Research GmbH is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
L
Laboratorio Reig Jofre, S.A.
Spain
Laboratorio Reig Jofre, S.A. is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
L
Luina Bio (now AcuraBio)
Australia
Luina Bio (now AcuraBio) is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
G
Grace Davison Chemicals (India) Pvt Ltd
India
Grace Davison Chemicals (India) Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
P
Praveen Laboratories Pvt Ltd
India
Praveen Laboratories Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Cleo Singapore
Singapore
Cleo Singapore is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Kekule Pharma Limited
India
Kekule Pharma Limited is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Nanomol Technologies S.A.
Spain
Nanomol Technologies S.A. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Gattefossé S.A.
China
Gattefossé S.A. is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
OPKO HEALTH
Israel
OPKO HEALTH is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
P
PrimePharma GmbH
Ireland
PrimePharma GmbH is a leading contract development and manufacturing organization headquartered in Ireland. We specialize in Formulation Development, Clinical Trial Materials, Biologics Manufacturer with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Adelco SA
Greece
Adelco SA is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
BioFusion JSC
Poland
BioFusion JSC is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Bruker Corporation
Switzerland
Bruker Corporation is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
C
Chemoforma AG
Switzerland
Chemoforma AG is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Loxim Industries Limited
India
Loxim Industries Limited is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
P
PurCell Bio
United States
PurCell Bio is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
C
Caplin Point Laboratories / Caplin Steriles
India
Caplin Point Laboratories / Caplin Steriles is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
A
ApexPharma Corp.
Belgium
ApexPharma Corp. is a leading contract development and manufacturing organization headquartered in Belgium. We specialize in Small Molecule API Manufacturer, Commercial Manufacturing, Packaging with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
I
ITECO Engineering
Italy
ITECO Engineering is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Centroflora Group
Brazil
Centroflora Group is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Cellab CDMO
Andorra
Cellab CDMO is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
Macleods Pharmaceuticals Ltd
India
Macleods Pharmaceuticals Ltd is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
A
AdvancedPharma GmbH
Spain
AdvancedPharma GmbH is a leading contract development and manufacturing organization headquartered in Spain. We specialize in Small Molecule API Manufacturer, Biologics Manufacturer with state-of-the-art facilities serving clients globally.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Peter Greven Nederland C.V.
Netherlands
Peter Greven Nederland C.V. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
M
Mithra Biotechnology Inc
Taiwan
Mithra Biotechnology Inc is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
Bliss GVS Pharma Ltd.
India
Bliss GVS Pharma Ltd. is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
R
RNP Pharmachem
India
RNP Pharmachem is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Fabtech Technologies International Ltd.
India
Fabtech Technologies International Ltd. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Bioprox SA (Bioprox Cultures / Bioprox Healthcare)
France
Bioprox SA (Bioprox Cultures / Bioprox Healthcare) is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
Interos Inc.
France
Interos Inc. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
YCP Consus / Consus Global
Indonesia
YCP Consus / Consus Global is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
GL Biochem (Shanghai) Ltd.
China
GL Biochem (Shanghai) Ltd. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
CBL Patras S.A.
Greece
CBL Patras S.A. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
UPM Pharmaceuticals
United States
UPM Pharmaceuticals is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
Macrocyclics, Inc.
United States
Macrocyclics, Inc. is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
Kinaxis
Canada
Kinaxis is a pharmaceutical CDMO offering comprehensive services.
Oral Solid DoseSolid Dose ManufacturingFormulation Development
A
Aptuit LLC
Italy
Aptuit LLC is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
Oleochemicals India Pvt. Ltd.
India
Oleochemicals India Pvt. Ltd. is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics Drug ProductBiologics Manufacturing
LOTTE BIOLOGICS
South Korea
LOTTE BIOLOGICS is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
TekniPlex (TekniPlex Healthcare)
Italy
TekniPlex (TekniPlex Healthcare) is a pharmaceutical CDMO offering comprehensive services.
Biologics Drug SubstanceBiologics ManufacturingFormulation Development
Frequently Asked Questions
What container formats are used for sterile injectables?+
Primary containers include: glass vials (2-50mL), ampoules (1-20mL), pre-filled syringes (0.5-2.25mL), cartridges (1.5-3mL), and IV bags (50-1000mL). Container selection depends on route of administration, dose volume, storage requirements, and whether the product is administered by healthcare professionals or self-administered by patients.
How do you assess sterility assurance at a CDMO?+
Key indicators: media fill (process simulation) success rates, environmental monitoring trending data, contamination investigation track record, facility design (isolator vs RABS vs conventional cleanroom), cleaning validation approach, and regulatory inspection history. Ask for the CDMO's most recent media fill reports and annual product review data showing contamination-related deviations.
Need help finding the right CDMO?
Our AI Matchmaker analyzes your project requirements and matches you with qualified manufacturing partners. Free for buyers.