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WHO-GMP & cGMP Certified CDMO
Contract Development & Commercial Manufacturing Services
Altora Lifesciences accelerates pharmaceutical commercialization for leading domestic brands, export distributors, and healthcare innovators. State-of-the-art automated lines, strict beta-lactam segregation, and end-to-end regulatory dossiers.
2.5B+
Annual Units Output
9 Lines
Dosage Form Facilities
35+
Export Market Dossiers
99.8%
Right-First-Time Yield
Core Competencies
The 4 Pillars of Altora CDMO Services
Turnkey pharmaceutical manufacturing solutions designed to eliminate supply chain volatility and provide uncompromised therapeutic compliance.
Pillar 01
Commercial Manufacturing
High-speed rotary presses, automatic blister packing, and isolated cleanrooms across 9 dosage forms.
✓ 2.5B+ units annual capacity
✓ Segregated beta-lactam suites
Pillar 02
Technology Transfer
Pre-formulation studies, analytical method development (AMD), and 3-batch commercial validation.
✓ 3 to 6 weeks transfer time
✓ HPLC & GC validation
Pillar 03
Regulatory Dossiers
State FDA third-party licensing, loan licenses, and ready ACTD/eCTD dossiers for global export markets.
✓ Zone IVb stability testing
✓ COPP & FSC certification
Pillar 04
Custom Packaging
High-barrier Alu-Alu blister foil, glass ampoules, pre-filled syringes, and GS1 2D DataMatrix serialization.
✓ Anti-counterfeiting tracking
✓ Turnkey brand cartons
Manufacturing Portfolio
Commercial Formulation Capabilities
Automated cGMP production lines covering oral solids, sterile parenterals, oral liquids, and topical formulations. Click any card to request a batch quote.
Tablets & Capsules
Solid Oral Dosages
High-speed rotary compression and encapsulation lines for immediate, sustained, modified, and enteric-coated release profiles.
Annual Capacity
1.2B+ Units
Quality Standard
cGMP / WHO-GMP
- Coated, uncoated & bilayer release tablets
- Hard gelatin & vegetarian (HPMC) capsules
- High-barrier Alu-Alu & PVC blister packaging
Softgel Capsules
Soft Gelatin Formulations
Precision continuous rotary die encapsulation lines designed for oil-based liquids, lipid emulsions, paste suspensions, and poorly soluble APIs.
Annual Output
600M+ Softgels
Fill Accuracy
±1.5% Precision
- Oily solutions, suspensions & self-emulsifying systems
- Gelatin & plant-based vegan tapioca/carrageenan shells
- Nitrogen-blanketed gelatin melting & oxygen-barrier sealing
Syrups & Liquids
Oral Liquid Solutions
Closed-loop automated sugar dissolution, homogenization, and multi-head sterile filling lines delivering particulate-free liquid suspensions.
Line Output
120 Bottles/min
Fill Volume
30ml – 500ml
- Pediatric drops, cough syrups & antacid suspensions
- 0.2 micron sterile multi-stage membrane filtration
- Nitrogen purging, induction sealing & ROPP cap sealing
Dry Syrups
Reconstitutable Oral Powders
Ultra-low humidity sterile suites for free-flowing antibiotic and sensitive pediatric dry powder suspensions reconstituted with purified water.
RH Level
< 20% Controlled
Dosing Accuracy
±1% Auger Fill
- Beta-lactam & Non-beta-lactam segregated filling zones
- Precision servo auger powder dosing with micro-weight feedback
- Supplied with sterile water for injection (WFI) ampoules
Pediatric & Ophthalmic Drops
Liquid Oral & Ocular Dosages
Precision sterile micro-volume liquid formulations engineered for pediatric administration, ocular ophthalmic relief, and otic/nasal applications.
Bottle Sizes
5ml – 30ml
Sterility Assured
0.22μm Filtered
- Calibrated drop-by-drop medical grade rubber & glass droppers
- Preservative-free and multi-dose buffered physiological osmolarity
- Blow-Fill-Seal (BFS) and conventional sterile dropper bottle packaging
Dry Powder Injections
Sterile Parenteral Powders
Ultra-pure aseptic powder micro-dosing and lyophilization suites for critical antibiotics, beta-lactams, and freeze-dried biological parenterals.
Filling Zone
Grade A / ISO 5
Leak Detection
100% High-Voltage
- Sterile Cephalosporin & Carbapenem dedicated isolated suites
- Precision auger & vacuum-wheel sterile micro-powder filling
- Bromobutyl rubber stoppers with aluminum flip-off seals
Ampoule Injections
Hermetic Glass Ampoules
Continuous automated ultrasonic washing, depyrogenating tunnel, and high-speed hermetic flame-sealing lines for sterile liquid parenterals.
Line Speed
240 Ampoules/min
Ampoule Sizes
1ml – 20ml OPC
- One-Point Cut (OPC) & color break ring Type I glass ampoules
- Pre- & post-filling inert nitrogen (N₂) purging loops
- Terminal steam sterilization & 100% optical leak testing
Vial Injections & Infusions
Sterile Parenteral Solutions
Advanced isolator-based aseptic processing and terminal sterilization lines producing glass infusion vials, small-volume parenterals, and PFS.
Cleanroom Class
ISO 5 / Grade A
Sterility Assurance
SAL 10⁻⁶ Level
- Sterile liquid vials (2ml to 100ml) & infusion bottles
- Pre-filled Syringes (PFS) & Form-Fill-Seal compatibility
- Automated high-speed optical particulate & cosmetic inspection
Ointments & Creams
Topical Semi-Solids
Planetary vacuum homogenizers and precision high-speed tube filling lines for dermatological creams, ophthalmic ointments, and medicinal gels.
Batch Range
50kg – 1,000kg
Tube Sizes
5g – 200g
- Hydrophilic creams, lipophilic ointments & clear gels
- Deaerated micronized active ingredient sub-micron dispersion
- Laminated, aluminum & plastic tube hermetic ultrasonic sealing
Execution Roadmap
5-Stage Tech Transfer & Batch Release Workflow
From confidentiality agreement to validated commercial batch release and temperature-controlled dispatch.
STAGE 01 · WK 1
Feasibility & NDA
Master formula evaluation, API compatibility, and raw material qualification under mutual NDA.
STAGE 02 · WK 2-3
Method Validation
GLP analytical method verification (HPLC/GC) and pilot scale trial batch execution.
STAGE 03 · WK 3-4
Regulatory Licensing
Submission for state FDA loan license or third-party license endorsement and dossier compilation.
STAGE 04 · WK 4-6
Process Validation
Commercial scale-up with 3 consecutive validation batches, IPQC, and sterility incubation.
STAGE 05 · WK 6+
QA Release & Dispatch
Final COA clearance, Zone IVb stability chamber charging, and temperature-controlled dispatch.
Altora Lifesciences Quality Assurance Guarantee
Custom formulation, technology transfer, and commercial-scale batch manufacturing
WHO-GMP Approved
cGMP Compliant
ISO 9001:2015
GLP Certified Labs
Partner with Altora Lifesciences Today
Contact our commercial development team for confidential formulation assessment, regulatory filings, or loan license procurement.