cGMP FDA

Sterile & Non-Sterile cGMP Manufacturing

We provide state-of-the-art manufacturing for both sterile and non-sterile pharmaceutical products under full cGMP compliance. Our facility features ISO-class cleanrooms for aseptic processing of sterile injectables, as well as dedicated suites for non-sterile production. With capabilities spanning small-scale clinical batches to larger commercial runs, we ensure rigorous quality control at every step:

  • Sterile Manufacturing: Aseptic fill-finish of injectables (such as vials and syringes) with meticulous environmental monitoring to ensure sterility.
  • Non-Sterile Manufacturing: Preparation of oral, topical, and other non-sterile dosage forms under strict hygiene and quality protocols.
  • Process Development: Optimization and scale-up of manufacturing processes from pilot batches to commercial production, ensuring efficiency and reproducibility.
Sterile & Non-Sterile cGMP Manufacturing