KPPT is one of the very few cGMP facilities with the capabilities to take your products all the way from early development stage through commercial supply — with the fastest turnaround in the industry.

At KPPT we have an extensive line of modern and up-to-date equipment to meet your R&D, Production, Packaging and Analytical requirements in a rapid and cost-efficient manner. Every part of the project is handled in-house, maintaining stringent quality standards at every step.

Full-Spectrum Manufacturing Capabilities

Aseptic Fill & Finish

Class 100 / ISO-5 certified clean rooms for sterile vial, syringe, and cartridge filling under strict cGMP conditions.

Lyophilization

Freeze-drying for biologics, proteins, and small molecules with full cycle development from bench to commercial scale.

Sterile Powder Filling

Aseptic powder filling for moisture-sensitive compounds including antibiotics, enzymes, and biologics.

Solid Oral Dosage Forms

Tablet compression, capsule filling, coating, and granulation under cGMP with full process validation.

Pre-Filled Syringes

Filling, stoppering, crimping, and inspection services for patient-ready primary container systems.

Potent & Cytotoxic Compounds

Isolator technology for safe handling of potent APIs and cytotoxic compounds including DEA scheduled substances.

Facility & Infrastructure

Our state-of-the-art manufacturing campus includes over 60,000 square feet of dedicated cGMP manufacturing and operational support space:

  • Over 10,000 sq.ft of cGMP manufacturing space with dedicated solid dose and sterile products areas
  • Independent HEPA/HVAC air handling systems and dust containment for each manufacturing suite
  • Class 100 / ISO-5 certified clean rooms for aseptic manufacturing
  • Over 50,000 sq.ft of operational support space for R&D, Analytical, and manufacturing logistics
  • Complete in-house QC Laboratory with modern analytical instrumentation
  • Full documentation and batch record management under 21 CFR Part 11 compliant systems

Regulatory Compliance

KPPT's manufacturing operations are designed and operated in full compliance with current Good Manufacturing Practice (cGMP) regulations:

FDA Registered & Inspected

Registered with the US Food and Drug Administration as a drug product manufacturer with a clean inspection history available upon request.

DEA Registered

Dual DEA registration — both "Researcher" (Schedules I–V) and "Manufacturer" (Schedules II–III) — for controlled substance drug products.

EU Annex 1 Compliant

EU cGMP compliant and Qualified Person (QP) inspected facilities, enabling supply to European markets and clinical trials.

ICH Guidelines

Full adherence to ICH Q7, Q8, Q9, Q10, and Q11 guidelines across process development, validation, and quality management.

From Development to Commercial — Seamlessly

1

Technology Transfer

Formal tech transfer from your internal team or from KPPT's own development labs, with full documentation review and gap analysis.

2

Process Validation

Three-batch process validation (PPQ) with pre-approved validation protocols and statistical acceptance criteria per FDA guidance.

3

Commercial Batch Manufacturing

Routine commercial production with full cGMP batch documentation, in-process controls, and QC release testing.

4

QC Release & Distribution

Certificate of Analysis issuance, stability management, and coordination with your logistics team for worldwide distribution.

Complete Confidentiality Guaranteed

All projects are executed under complete confidentiality agreements, tailored to client-specific needs and in strict compliance with cGMP. KPPT's experienced team understands the competitive and time-sensitive nature of pharmaceutical commercialization.

For an updated list of equipment and instruments available in our facility, please contact info@kppt.com.