Novasep manufactures and sells a wide range of cGMP pre-formulated nitroglycerin. We can provide you with customized formulations meeting your specifications and production needs.
With more than 140 years of experience with explosives and energetic chemical reactions, Novasep’s Leverkusen site (founded in 1871 and taken over by Alfred Nobel in 1873) is one of the preferred manufacturers of pre-formulated nitroglycerin for pharmaceutical applications.
Our nitroglycerin formulations are:
| Excipient | Maximum Assay
(w/w) |
Formulations |
| Lactose anhydrous | 10% | Solid |
| Lactose monohydrate | 2% | Solid |
| Glucose anhydrous | 2% | Solid |
| Ethanol absolute | 5% | Liquid |
| Ethanol absolute | 1% | Liquid |
| Ethanol 96% | 1% | Liquid |
| 1,2-Propandiol | 10% | Liquid |
| Miglyol 812 | 5% | Liquid/Gel |
| Adhesives | Customized | Viscous |
| Ready-to-fill solution | Customized | Liquid/Gel/Paste |
Our pre-formulated nitroglycerin is produced in strict compliance with current Good Manufacturing Practices and the manufacturing site has a strong track record of high quality production including many successful inspections by FDA and German Health Authorities. We hold a drug manufacturing license according to the German Drug Law. The site also holds other certifications such as ISO 14001/9001, Korean FDA, and Japan PMDA.
Beyond the quality aspects, our customers will benefit from our strength in safety, based on our extensive experience in handling explosives according to the German Explosive Acts. Thus we can help to guarantee your supply chain.
We hold a CEP for nitroglycerin ethanolic solutions and various EU and US DMFs. Through our regulatory experts and our documentation at hand, we support you to be compliant with the regulatory requirements in the pharmaceutical market.
Our nitroglycerin is used as solid, gel, or liquid for applications including:
- Adhesive solutions for patches
- Pastes for reservoir patches
- Gelatinous capsules
- Spray solution
- Pre-mixes for vials, tablets and capsules
- Gels and ointments
Upon customer request, we can, together, develop customized solutions, like specific pre-formulations or packaging solutions. We are equipped to manufacture pre-formulations up to several tons.
