For more than 50 years, Axplora has been a leader in the production of small molecule APIs for the generic industry. We offer drug products to generic pharmaceutical Drug manufacturers (MAHs)for applications including respiratory, inflammatory, and liver diseases. We have a recognized expertise in the pre-formulated nitroglycerin production (also called Glyceryl Trinitrate or GTN) for pharmaceutical application thanks to more than 150 years of experience in explosives and energetic chemistry.
A demonstrable expertise in preformulated nitroglycerin production
As a world leading API products manufacturer for more than 75 years, we offer Nitroglycerin drug with very high quality. Nitroglycerin production is located in our facility in Leverkusen in Germany, and we also have a backup nitration plant at the same site for business continuity and that enables us to cover all demands from our customers worldwide.
Our Nitroglycerin production is GMP certified, and we are holding a manufacturing license according to the German drug law. We have been successfully certified several times by world leading organizations like US FDA, European Medicines Agency and Japanese PMDA.
In addition, we have a strong regulatory affairs assistance to support our customers worldwide.
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.
Our preformulated Nitroglycerin generic product
Our preformulated nitroglycerin drug is used as solid, gel, or liquid forms:
- Adhesive solutions for patches
- Pastes for reservoir patches
- Solutions for Gelatinous capsules
- Spray solution
- Pre-mixes for parenteral products, tablets and capsules
- Gels and ointments
Nitroglycerin drug product is used in various therapeutic areas including:
- Angina pectoris
- Acute Myocardial Infarction
- Severe Hypertension
- Acute Coronary Artery Spasms
- Heart diseases
- Anal fissures and hemorrhoids
Our center of excellence for energetics chemistry
The site holds certifications such as ISO 9001/50001, Korean FDA, and Japan PMDA.
The pre-formulated nitroglycerin drug is produced in strict compliance with current Good Manufacturing Practices (cGMP) in our manufacturing site in Leverkusen in Germany where we have a specific expertise in handling shock, friction, and thermal sensitive chemicals such as nitroglycerin.
Our Leverkusen manufacturing site has a strong track record of high-quality production including many successful inspections by FDA and German Health Authorities.
If you are interested in speaking with one of our experts about our generic drug needs, connect with us now!
If you want to get more information about our API portfolio, download our full catalog.