Alchem International Drug Master Files (DMF) are prepared in CTD (Common Technical Document format) for submission to regulatory authorities for drug registration underpinning the consistency and quality of our drug APIs for medicine and traditional herbal medicines registrations. Alchem International provides world class technical and regulatory support and has filed DMFs in over 25 countries worldwide.

Tropane Alkaloids

  • Scopolamine Base CTD DMF
  • Scopolamine N Butyl Bromide CTD DMF
  • Scopolamine Hydrobromide CTD DMF
  • Scopolamine Methyl Bromide CTD DMF
  • Cimetropium Bromide CTD DMF
  • Homatropine Methyl Bromide CTD DMF
  • Hyoscyamine Sulphate CTD DMF
  • Atropine Sulphate CTD DMF
  • Digoxin CTD DMF
  • Yohimbine HCl CTD DMF

Nicotine for substitution products
  • Nicotine (EP/USP) CTD DMF
  • Nicotine Polacrilex CTD DMF

Muscle Relaxant/Anti-inflammatory
  • Enoxolone (EP) CTD DMF
  • Thiocolchicoside (IP/FP/KP) CTD DMF

Gout Treatment
  • Colchicine (BP/EP/USP) CTD DMF

  • Sennosides 60% (USP) CTD DMF

Cardiovascular Treatment
  • Digoxin (BP/EP/USP/JP) EU CEP (COS) and DMF
  • Vincamine CTD DMF
  • Vinpocetine CTD DMF
  • Pygeum Extract (CITES certified) DMF under development.