Capability
Sterile Injectable CDMOs
Compare CDMOs with sterile injectable manufacturing capabilities. Filter by container type, aseptic technology, and regulatory approvals.
50 companies listed
About Sterile Injectable Manufacturing
Sterile injectable manufacturing produces parenteral drug products -- formulations administered by injection (intravenous, subcutaneous, intramuscular, intrathecal). These products require the highest level of manufacturing control because they bypass the body's natural defense barriers. Any microbial, particulate, or endotoxin contamination can be life-threatening.
The sterile injectable market is growing faster than overall pharma, driven by biologics (monoclonal antibodies, ADCs), specialty injectables (long-acting formulations, complex generics), and the shift toward self-administered subcutaneous products. Capacity remains constrained globally, with lead times of 12-24 months at many CDMOs.
Companies (50)
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CellPharma AG
Switzerland
CellPharma AG is a leading contract development and manufacturing organization headquartered in Switzerland. We specialize in Cell & Gene Therapy, Formulation Development, Small Molecule API Manufacturer with state-of-the-art facilities serving clients globally.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
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GlobalPharma AG
Italy
GlobalPharma AG is a leading contract development and manufacturing organization headquartered in Italy. We specialize in Small Molecule API Manufacturer, Biologics Manufacturer with state-of-the-art facilities serving clients globally.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Lonza
China
Lonza is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Revatis
Belgium
Revatis is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Eskay Iodine Pvt Ltd
India
Eskay Iodine Pvt Ltd is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
GC Cell
South Korea
GC Cell is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Recipharm (Rechon Life Science AB)
Sweden
Recipharm (Rechon Life Science AB) is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Elementis Pharma GmbH
Germany
Elementis Pharma GmbH is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Emergent BioSolutions
Canada
Emergent BioSolutions is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Synbias Pharma AG (Synbias–Gemini Group)
Germany
Synbias Pharma AG (Synbias–Gemini Group) is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Fraunhofer-Gesellschaft
Germany
Fraunhofer-Gesellschaft is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Integer Holdings Corporation
China
Integer Holdings Corporation is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Fabtech Technologies Limited
India
Fabtech Technologies Limited is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Exemed Pharmaceuticals
India
Exemed Pharmaceuticals is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Altruist Biologics
China
Altruist Biologics is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
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GenePharma B.V.
France
GenePharma B.V. is a leading contract development and manufacturing organization headquartered in France. We specialize in Small Molecule API Manufacturer, Clinical Trial Materials with state-of-the-art facilities serving clients globally.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Gennex Laboratories Limited
India
Gennex Laboratories Limited is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
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Chengdu Pukang Biotechnology Co., Ltd.
China
Chengdu Pukang Biotechnology Co., Ltd. is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Morepen Laboratories Limited
India
Morepen Laboratories Limited is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
ITW Reagents (PanReac AppliChem)
Germany
ITW Reagents (PanReac AppliChem) is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
FREZYDERM S.A.
Greece
FREZYDERM S.A. is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
PENMIX Co. Ltd.
South Korea
PENMIX Co. Ltd. is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
M
Mytos Bio Ltd
United Kingdom
Mytos Bio Ltd is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
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Grace Fine Chemical Manufacturing Services
China
Grace Fine Chemical Manufacturing Services is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Salinen Austria AG
Austria
Salinen Austria AG is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Edelmann GmbH
Brazil
Edelmann GmbH is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Vijayasri Organics Private Limited
India
Vijayasri Organics Private Limited is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
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CoastalPharma Inc.
South Korea
CoastalPharma Inc. is a leading contract development and manufacturing organization headquartered in South Korea. We specialize in Packaging, Small Molecule API Manufacturer with state-of-the-art facilities serving clients globally.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
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BioPharma B.V.
United States
BioPharma B.V. is a leading contract development and manufacturing organization headquartered in United States. We specialize in Clinical Trial Materials, Commercial Manufacturing with state-of-the-art facilities serving clients globally.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
P
PrecisionPharma Pty Ltd
Sweden
PrecisionPharma Pty Ltd is a leading contract development and manufacturing organization headquartered in Sweden. We specialize in Formulation Development, Commercial Manufacturing with state-of-the-art facilities serving clients globally.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Quasar Medical
China
Quasar Medical is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
MabPlex International
China
MabPlex International is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Custom Pharma Services
United Kingdom
Custom Pharma Services is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
TSafe GmbH
Germany
TSafe GmbH is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Pinnacle Life Science
India
Pinnacle Life Science is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
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Anhui Qingyun Pharmaceutical and Chemical Co., Ltd.
China
Anhui Qingyun Pharmaceutical and Chemical Co., Ltd. is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Argonaut Manufacturing Services
United States
Argonaut Manufacturing Services is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
C
CHANGZHOU UNITED CHEMICAL CO., LTD
China
CHANGZHOU UNITED CHEMICAL CO., LTD is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
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Berry Global
China
Berry Global is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Leadcandidate
United Kingdom
Leadcandidate is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Eurotherm Ltd
United Kingdom
Eurotherm Ltd is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Capsulit S.P.A.
Italy
Capsulit S.P.A. is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Pfizer CentreOne
Belgium
Pfizer CentreOne is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
India Phosphate
India
India Phosphate is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
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Shenzhen Hybio Pharmaceutical Co. Ltd.
China
Shenzhen Hybio Pharmaceutical Co. Ltd. is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
AmbioPharm
China
AmbioPharm is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
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Neville and More
United Kingdom
Neville and More is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Ten23 Health
Switzerland
Ten23 Health is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Gland Pharma
Belgium
Gland Pharma is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Taiwan Hopax Chemicals Mfg. Co., Ltd
China
Taiwan Hopax Chemicals Mfg. Co., Ltd is a pharmaceutical CDMO offering comprehensive services.
Sterile InjectableSterile Fill/FinishFill/Finish (Vials)
Frequently Asked Questions
What are the key quality considerations for sterile injectables?+
Critical quality attributes include: sterility (no viable microorganisms), endotoxin levels (below specified limits per dose), particulate matter (visible and sub-visible particle counts), container closure integrity (preventing microbial ingress), potency/assay (active ingredient content), pH, osmolality, and appearance. Each attribute requires validated analytical methods and in-process controls.
How do you assess a CDMO's sterile manufacturing capability?+
Key indicators include: recent regulatory inspection history (FDA, EMA), media fill success rates, environmental monitoring data trends, contamination investigation track record, facility design (isolator vs RABS vs conventional cleanroom), equipment age and maintenance programs, and personnel training/qualification programs. Ask for their most recent media fill reports and environmental monitoring trending data.
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