Anise manufacturers

About alpha-amylase

Alpha-amylase manufacturers include industrial enzyme producers such as Novonesis, IFF and Amano Enzyme, and Opella (Sanofi's consumer health business), which sells Maxilase in France. Alpha-amylase is an enzyme that breaks down starch. As a medicine, it is used in Maxilase tablets and syrup as an anti-inflammatory adjunct for sore throat. It is also a component of pancreatic enzyme products. Pharmaceutical companies can source alpha-amylase tablets, syrup and enzyme API through out-licensing, supply or technology transfer.

Alpha-amylase key facts

Alpha-amylase manufacturers and licensing history

Maxilase has been sold in France since the late 1960s and is now marketed by Opella Healthcare France, Sanofi's consumer health business. The syrup was first authorised in 1968, and the 3,000 U CEIP coated tablets in 1998 and 2010.

Industrial alpha-amylase is produced in large volumes by fermentation, mainly using Bacillus bacteria or Aspergillus fungi. Novonesis (formerly Novozymes and Chr. Hansen), IFF and Amano Enzyme are among the major producers. Most output goes to food, brewing and starch processing, so pharmaceutical-grade material is a small share.

Buyers should confirm pharmaceutical grade, enzyme activity in Ph. Eur. units, the microbial source, allergen data and GMP status before choosing a supplier.

Alpha-amylase dosage forms and dossier types

Alpha-amylase is marketed as coated tablets and syrup for sore throat, and as a component of pancreatic enzyme products.

Alpha-amylase regulatory and patent status

Alpha-amylase is off-patent. In France, Maxilase tablets and syrup are authorised as non-prescription medicines and are not reimbursed. Labels limit use to 5 days without medical advice and warn about hypersensitivity, including anaphylaxis. Enzyme activity is expressed in CEIP units on the label, with conversion to Ph. Eur. units.

Alpha-amylase mechanism of action and therapeutic use

Alpha-amylase breaks down starch into smaller sugars. In throat preparations, it is used for its anti-inflammatory effect, which helps relieve the swelling and discomfort of a sore throat without fever. Maxilase tablets are for adults, and the syrup is for children and infants. If a bacterial infection is suspected, antibiotic treatment should be considered instead.

Alpha-amylase licensing and sourcing

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

Frequently asked questions about alpha-amylase

Who are the main alpha-amylase manufacturers? Opella, Sanofi's consumer health business, sells Maxilase in France. Industrial alpha-amylase is made by enzyme producers such as Novonesis, IFF and Amano Enzyme.

What is alpha-amylase used for in medicine? Alpha-amylase is used in Maxilase tablets and syrup as an adjunct treatment for sore throat. It is also one of the enzymes in pancreatic enzyme products for digestion.

What is the difference between alpha-amylase and amylase? Alpha-amylase is the main type of amylase in humans and most medicines. "Amylase" can also refer to other types, such as beta-amylase in plants.

What forms and strengths of alpha-amylase are available? Alpha-amylase is available as 3,000 U CEIP coated tablets and 200 U CEIP/ml syrup, in the Maxilase range.

Is alpha-amylase safe? Alpha-amylase is generally well tolerated, but it can cause allergic reactions, including anaphylaxis, sometimes from the first dose.