Drug Master Files

Your Partner in Pharmaceutical Regulatory Service


Drug Master File (DMF) is a master document containing complete information on API compliance for open and closed part.

The DMF contains confidential information on a drug product’s chemistry, manufacture, raw materials, stability, purity, impurity profile, and packaging.

Our service covers Type II DMF’s for drug substances (API’s) and Type IV DMF’s for excipients (inactive ingredients). All DMF’s are prepared in the Common Technical Document (CTD) format stipulated by the FDA.

It is a submission to FDA covering factual and complete information on its chemistry, stability, purity, impurity profile, packaging and cGMP status of any API.

We also perform the following studies, in co-operations to DMF preparation

  • Structural Elucidation Studies (Elemental Analysis, IR, Mass, MR C & H, XRD, DSC),
  • Analytical Report (COA)
  • Analytical Method Validation
  • Process Validation
  • Stability data studies
  • Determination & Validation of Potential Impurities & Solvent Impurities

We have tie-ups with well established labs (NABL Certified) to carry out such analytical testing. (All the data supported by necessary Chromatograms & Spectrums).