CDMO Services

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

• Oncology

• Anti-infectives

• CNS & Pain Management

• Endocrinology & Women’s Health

• Cardiology & Critical Care

• Biosimilars & Biologics

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