KPPT offers comprehensive pharmaceutical packaging services under cGMP conditions, ensuring your drug products are properly protected, accurately labeled, and compliant with all regulatory requirements — from early clinical supply through commercial distribution.
Our packaging capabilities are fully integrated with our manufacturing operations, allowing seamless handoff from production to packaging without the risk, delay, or cost of third-party logistics. Every packaging operation is executed under strict quality controls with full documentation.
Primary Packaging — Sterile Container Systems
Pre-Filled Syringes
Aseptic filling, stoppering, crimping, and visual inspection of pre-filled syringes using primary containers from leading global suppliers. Ready for labeling and secondary packaging.
Cartridges & Autoinjectors
Cartridge filling and assembly for autoinjector systems, meeting patient-ready delivery requirements for parenteral biologics and small molecules.
Vials & Ampules
Sterile vial and ampule filling, stoppering, and crimp sealing in Class 100 / ISO-5 certified clean rooms under stringent aseptic conditions.
HDPE Dropper Bottles
Filling and sealing of HDPE dropper bottles for ophthalmic, otic, and nasal preparations under appropriate cleanroom conditions.
Secondary & Clinical Trial Packaging
- Customized blister card packaging for oral solid dosage forms
- Single and double-blinded clinical study kit assembly and labeling
- Placebo kit packaging matching active drug product appearance
- Randomization-level labeling support for blinded clinical studies
- Comparator product over-encapsulation and matching packaging
- Patient wallet cards and dispensing units
- Multi-dose and unit-dose packaging configurations
- Bulk drug product packaging for distribution
Labeling & Regulatory Compliance
All KPPT labeling operations comply with 21 CFR Part 201 requirements for prescription drug labeling, as well as applicable clinical trial labeling requirements under ICH E6(R2) Good Clinical Practice guidelines.
- IND clinical trial labeling per FDA and ICH requirements
- NDA and ANDA commercial labeling support
- Comparator product relabeling for clinical trials
- Multi-language label design and application
- Bar coding and serialization support
- Label reconciliation and line clearance documentation
CTM Repository & Distribution Services
Clinical Supply Storage
Temperature-controlled storage (frozen, refrigerated, controlled room temperature) for clinical trial materials with full chain-of-custody documentation and quarterly inventory reporting.
Clinical Site Distribution
Worldwide distribution coordination from KPPT's facility directly to clinical trial sites, with temperature monitoring during shipment and import/export documentation support.
Inventory Management
Real-time inventory tracking, expiry management, and resupply coordination to ensure clinical sites maintain adequate drug supply throughout the study.
Returns & Reconciliation
Receipt and reconciliation of returned clinical trial materials with full documentation for trial closeout and regulatory inspection readiness.
Container Closure Integrity & Quality
All packaging operations at KPPT include rigorous quality controls to ensure container closure integrity and product protection:
- Container closure compatibility studies with drug product
- Visual inspection of all filled and sealed primary containers
- Leak testing and headspace gas analysis where applicable
- Torque and crimp force verification
- In-process checks and AQL sampling per batch specifications
- Packaging validation studies in support of regulatory submissions
Integrated Manufacturing to Packaging — No Handoffs
Because KPPT handles both manufacturing and packaging in-house, your drug product never leaves our cGMP environment between production and final labeled package. This eliminates transfer risk, preserves the integrity of your product, and dramatically reduces total cycle time to clinical site delivery or commercial distribution.