Drug Master Files
Compilation for open and closed part.
Drug Master File (DMF) is a master document containing complete information on API.
The DMF contains confidential information on a drug product’s chemistry, manufacture, raw materials, stability, purity, impurity profile, and packaging.
Our services cover Type II DMFs for drug substances (APIs) and Type IV DMFs for excipients (inactive ingredients). All DMFs 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).