Lipase manufacturers

About amylase

Amylase manufacturers in pharmaceuticals mainly supply pancreatic enzyme products (pancrelipase or pancreatin), such as Creon, Zenpep and Pancreaze, which combine amylase with lipase and protease. Amylase is the digestive enzyme that breaks down starch. In medicine, it is used as part of enzyme replacement therapy for exocrine pancreatic insufficiency and in digestive aids. Pharmaceutical companies can source pancreatic enzyme capsules, digestive enzyme products and amylase API through out-licensing, supply or technology transfer.

Amylase key facts

Amylase manufacturers and licensing history

Amylase is used in medicine mainly as part of pancreatic enzyme products, made from pig pancreas. These products were sold for decades in the US without approval. Because enzyme content varied, the FDA required all makers to obtain approval, with a final deadline of 28 April 2010.

The FDA approved Creon in May 2009, Zenpep in August 2009 and Pancreaze in April 2010. Ultresa and Viokace followed in March 2012, and Pertzye was also approved. Outside the US, Creon and similar pancreatin products are widely sold.

Amylase from fungi, such as Aspergillus oryzae, is used in over-the-counter digestive aids. In Japan, diastase is a pharmacopoeial digestive enzyme. Buyers should confirm the enzyme source, activity, viral safety for porcine material and GMP status before choosing a supplier.

Amylase dosage forms and dossier types

Amylase is supplied mainly as part of pancreatic enzyme capsules, and as fungal enzymes in digestive aids.

Amylase regulatory and patent status

In the US, all pancreatic enzyme products must have FDA approval, and unapproved products have been off the market since 28 April 2010. The approved products are not interchangeable, because their enzyme content and formulations differ. In the EU, pancreatin products are authorised nationally. Amylase itself is off-patent, but formulation patents may apply to specific products.

Amylase mechanism of action and therapeutic use

Amylase breaks down starch into smaller sugars that can be absorbed. In pancreatic enzyme products, it works together with lipase, which digests fat, and protease, which digests protein. These products are taken with meals to treat exocrine pancreatic insufficiency, for example in cystic fibrosis, chronic pancreatitis or after pancreas surgery. Dosing is usually based on lipase units.

Amylase licensing and sourcing

Amylase suppliers and licensing partners typically offer pancreatin API supply, finished-product supply or dossier out-licensing. Buyers usually compare GMP status, enzyme source and activity, viral safety data and territory availability. Current offers and supplier contacts are listed among the amylase manufacturers on Pipelinepharma.

Frequently asked questions about amylase

Who are the main amylase manufacturers? In medicine, amylase is supplied mainly in pancreatic enzyme products such as Creon, Zenpep and Pancreaze. Fungal amylase for digestive aids comes from industrial enzyme producers.

What is amylase used for in medicine? Amylase is part of pancreatic enzyme products used to treat exocrine pancreatic insufficiency, together with lipase and protease. It is also used in digestive aids.

Are pancreatic enzyme products interchangeable? No. The FDA states that approved pancreatic enzyme products are not interchangeable, because their enzyme content and formulations differ.

What forms of amylase products are available? Amylase is available mainly in delayed-release pancreatic enzyme capsules, non-coated pancrelipase tablets and fungal enzyme digestive aids.

What is the difference between amylase and alpha-amylase? Alpha-amylase is the main type of amylase in humans and in most medicines. The general term "amylase" also covers other types, such as beta-amylase in plants.