Pancreatin

Pancreatin is a standardized, highly active, single-species-derived enzyme combination that is largely identical to the natural physiological pattern of human pancreatic enzymes. These qualities make pancreatin from porcine intestinal mucosa the ideal product for the management of pancreatic dysfunction.

The pancreatic glands used as the starting material for pancreatin production are obtained from slaughtered pigs raised for human consumption.
Sourcing is monitored by veterinary surgeons and takes place under standardized conditions. The sources are selected EU-certified abattoirs. The deep-frozen organs are then transported to the pancreatin plant in Uetersen where active ingredient extraction takes place according to a patented process.

Specification
Our pancreatin complies with the Pancreas Powder PhEur monograph and with the requirements of the "Pancrelipase" monograph in the United States Pharmacopoeia, as revised.

Testing is performed in-house

 

 

Isopropanol is used as a solvent in the manufacturing process. The upper limit is set at 0.5%, ensuring compliance with CPMP/ICH/283/95 Note for Guidance.
Our pancreatin is stable for at least 3 years at 25°C / 60% relative humidity in the intact container.

Pancreatin should be kept in a tightly closed container after opening and protected from damp.

Documentation
We have built up an extensive store of regulatory documentation on the basis of our many years of experience with pancreatin and pancreatin products. Documents on hand include a European Drug Master File which is available upon request.

For more information, please send for our brochure.