Generic API: Nitroglycerin

Production and pre-formulation of a generic active ingredient: Nitroglycerin

Novasep is a leading manufacturer of pre-formulated nitroglycerin (glycerol trinitrate) under cGMP conditions, a major API used in cardiology, e.g. acute heart attack and angina pectoris.

Novasep’s Leverkusen site has an extensive track record in producing and pre-formulating nitroglycerin at production scale (100’s of tons of formulated product per year). The safe production and pre-formulation of nitroglycerin requires all the know-how of Novasep in safety-critical reactions, gained over 135 years in doing hazardous chemistry. Based on this experience, Novasep has developed its own equipment to ensure a safe and efficient production and pre-formulation of glycerol trinitrate as per customer requirements.

Novasep can supply you with nitroglycerin as pre-formulation in adhesives for patches and liquid formulations; sprays; injections and infusions; mixtures in solids for tablets and premixes; or pre-formulations for gels and ointments.

DMFs are filed for pure nitroglycerin and some of the pre-formulations in many countries. For nitroglycerin in ethanol, a CEP has been granted by EDQM. Novasep is an Accredited Foreign Manufacturer for Japan.

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