Manufacture of Active Pharmaceutical Ingredients (APIs)

All APIs manufactured at SPL comply with the current GMP guideline - ICH Q7A. The facility and process go through a systematic protocol of validation prior to commercial production. All of the products manufactured by SPL will be supported by Drug Master Files to be filed in USA or EU.

We are involved in the manufacturing of Specialty Pharmaceutical and Fine Chemical Intermediates, Contrast Media Compounds, CNS products and few customer specific API molecules.

  Phase 1 API products       Phase 2 API Products
  Iopamidol      Modafinil
  Iohexol      Pentosan Polysulfate
  Propyphenazone      Olsalazine Sodium
  Ioversol      Balsalazide
        Sodium Phenyl Butyrate