At Munit, we offer fully GMP-compliant micronization services designed to meet the highest pharmaceutical standards. With over 60 years of experience in particle engineering, our facilities provide secure, traceable, and efficient API size reduction — from early-stage development to commercial scale.
Why Choose GMP API Micronization?
Micronization under GMP ensures that every batch meets regulatory and quality standards. It’s not just about reducing particle size — it’s about delivering consistency, safety, and performance for every formulation. Munit’s expertise in spiral jet milling provides an optimal balance between performance and control.
Technologies and Equipment
Munit utilizes proprietary spiral jet mill systems, engineered in-house and continuously improved for better yields and tighter particle distribution. Our cleanroom-classified environments support processing under full GMP, ensuring reproducibility and contamination control. Our facilities also offer batch-specific containment, nitrogen inerting, and real-time analytical support.
Regulatory Compliance and Traceability
Each micronization process is fully documented, including batch records, cleaning validation, and QC testing. We support regulatory inspections and customer audits, maintaining certifications aligned with EU GMP and ISO 9001 standards. Our system ensures traceability from raw material to final API output.
Scalability from R&D to Commercial Production
From milligram-scale feasibility studies to ton-scale production, Munit ensures scalability without compromising quality. This is essential for maintaining consistency across development stages, particularly in the production of HPAPIs and complex formulations.
Ensure regulatory success and particle precision.
Contact Munit to discuss your GMP API micronization needs.