Drug Master File (DMF)
Drug Master File (DMF)
Compilation for open and closed part.

Drug Master File (DMF) is a master document containing complete information on  API.

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, NMR 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).


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