🧪 Manufacturing Capabilities
Aevum Zenth's private-label pharma division operates cGMP-compliant facilities across North America, Europe, and Southeast Asia. We support brands from initial formulation through commercial-scale production, offering flexible MOQs and dedicated project management.
- Oral solids (tablets, capsules, dispersible films)
- Topicals & transdermatics (creams, gels, patches, serums)
- Liquid & semi-solid dosage forms (syrups, suspensions, emulsions)
- Nutraceutical & dietary supplement manufacturing
- Clinical trial supply (Phase I–IV packaging & serialization)
⚙️ Therapeutic & Product Matrix
| Category | Form Types | Regulatory Path | Min. Order Qty |
|---|---|---|---|
| OTC Pharmaceuticals | Tablets, Capsules, Liquids | FDA Monograph / NDA | 10K units |
| Nutraceuticals | Softgels, Powders, Gummies | FDA DSHEA / EU 1925/2006 | 5K units |
| Dermatology & Cosmeceuticals | Emulsions, Serums, Patches | FDA Cosmetic / EU CPNP | 3K units |
| Specialty / Prescription | Controlled Release, Lyophilized | ANDA / MA / BLA | Custom |
| Veterinary | d>Oral, Topical, Injectable | FDA CVM / EMA VMD | Custom |
🔬 End-to-End Development Process
Feasibility & Brief
Active ingredient review, stability profiling, regulatory pathway mapping, and commercial viability assessment.
Formulation R&D
Custom compounding, excipient optimization, bioavailability enhancement, and prototype generation.
Scale-Up & Validation
Pilot batch execution, process validation (PPQ), in-process QC, and analytical method transfer.
Regulatory & Filing
DMF authorizations, labeling review, pharmacovigilance setup, and submission to FDA/EMA/Health Canada.
Commercial Manufacturing
Continuous production, serialization, primary/secondary packaging, and 3PL distribution coordination.
Lifecycle Support
Annual product quality reviews, stability monitoring, formula iterations, and post-market surveillance.
🛡️ Quality, Compliance & Certifications
All private-label operations adhere to stringent global pharmaceutical standards. Third-party audits, batch record reviews, and continuous process verification are standard.