Pharma CDMO Injectable Services
Your Trusted Partner for End-to-End Injectable Development & Manufacturing
We specialize in providing comprehensive Contract Development & Manufacturing Organization (CDMO) solutions for sterile injectable products across multiple dosage forms and therapeutic categories. Our expertise ensures seamless progression from concept to commercial launch.
Core Service Capabilities
1. Formulation Development
Pre-formulation studies & excipient compatibility
Solubilization, stabilization, and preservative strategies
Novel delivery systems: Liposomes, nanoparticles, microspheres, ISFDs
Long-acting depot injectables & sustained release formulations
2. Analytical & Stability Services
Method development & validation (ICH Q2-compliant)
Comprehensive characterization (HPLC, LC-MS, particle sizing)
Accelerated & long-term stability studies (ICH climatic zones)
3. Sterile Manufacturing
Aseptic processing (liquid, lyophilized, suspensions, emulsions)
Vial, pre-filled syringe, and cartridge filling
Small-scale clinical batches to large-scale commercial production
cGMP-compliant cleanrooms (ISO Class 5 / EU Grade A/B)
4. Packaging & Device Integration
Pre-filled syringes, auto-injectors, dual-chamber systems
Secondary packaging with serialization & aggregation
Cold-chain compatible packaging
5. Regulatory Support
Global regulatory dossier preparation (CTD, ANDA, NDA, IMPD)
Pre-approval inspection readiness
Support for 505(b)(2) and biosimilar pathways
Injectable Dosage Forms We Support
Aqueous & non-aqueous solutions
Lyophilized powders
Suspensions & emulsions
Depot injections (microspheres, gels, implants)
Targeted delivery injectables (antibody-drug conjugates, nanoparticles)
Therapeutic Areas
Why Partner With Us
End-to-end solutions: From early R&D to commercial supply
Flexible batch sizes: Clinical to commercial scale
Regulatory excellence: Global compliance (USFDA, EMA, MHRA, WHO GMP)
Innovation focus: Advanced delivery systems & lifecycle management
