Production of Active Pancreatin
Production of active pharmaceutical ingredient
The extraction and purification of complex mixtures of substances and substances of biological origin while maintaining their functionality is one of Nordmark's core competences. Worldwide drug licenses, such as the FDA approval for the US market, confirm our highly qualified manufacturing process.
High-quality starting material
Nordmark uses only pancreas glands from animals that are under constant veterinary control and approved for food purposes as raw material for pancreatin manufacturing. We additionally audit the certified supplier slaughterhouses.
Extraction and purification
The active ingredient pancreatin is obtained from the porcine pancreatic glands by extraction, purification and subsequent drying of the extract.
Due to its sensitivity to temperature and moisture, a finely tuned and gentle treatment of the enzyme mixture of lipase, amylase and proteases is required. Our company-owned, optimised manufacturing process allows us to produce pancreatin with a high specific activity.
The solvent used for pancreatin purification is recycled at Nordmark with the help of a recovery facility and reused after corresponding quality control.
After purification, the pancreatin is separated from the solvent and dried. This is particularly challenging due to the temperature sensitivity of the enzymes.
With our special Nordmark expertise, we control the drying process in such a way that it preserves their activity.
API as powder or pellet
Nordmark produces the active ingredient pancreatin as a powder and in the form of pellets. Both forms of the active ingredient can be processed into finished medicinal products in our own manufacturing plant via intermediate stages.
Nordmark pancreatin powder has excellent technical application properties due to our special manufacturing process. It is characterised by its good flowability and high bulk density. After addition of tabletting excipients, it can be processed directly on high-performance tablet presses. We supply various product qualities according to customer requirements and in compliance with PhEur or USP.
The core of our pancreatin pellets is free of any additional excipients and consists of 100 per cent active pharmaceutical ingredient. Therefore, high specific enzyme activities can be achieved, resulting in the opportunity to produce small patient-friendly capsules with high pancreatin dosage.
Qualities with defined specifications
With the different enzyme activities of our pancreatin active ingredients, we can serve the most diverse enzyme specification needs of our customers.
Nordmark carries out extensive stability studies for the various API qualities, intermediate and finished medicinal products of the pancreatin. All stability storages of active ingredients and medicinal products takes place in Nordmark's own climate chambers.
Approvals and documentation
Extensive regulatory documentation is available for our pancreatin products, from the active pharmaceutical ingredient to the finished medicinal product.