US raw materials supplier Originates has boosted its pharmaceutical bovine hide gelatin manufacturing capacity with the addition of two new ISO 9000/9001 certified, GMP-standard production facilities in South America.
Gelatin is the leading excipient in the pharmaceutical industry and is used in a wide variety of applications ranging from the production of hard and soft drug capsules to film formation and tablet binding.
While surveys like Freedonia’s “Excipients to 2011” report predict that cellulose derivatives will eventually take the top spot, gelatin is expected to maintain a major share of the $2.3bn (€1.6bn) a year pharma excipients market for years to come.
Gelatin also has uses in the food, cosmetics and dietary supplements industries as anything from a flavour enhancer, a source of collagen and the amino acids L-proline, L-hydroxyproline and glycine.
Florida-based Originates, previously known as GMI Gelatin, specializes in the production of hydrolised type B bovine hide-derived gelatins for pharmaceutical and food technology applications.
In a press statement operations manager Daniel Minski said that the expansion reinforces Originates “position as a leading supplier of gelatin in North America and the rest of the world.”
Originates believes that locating the new plants close to its raw materials source allows it to be more selective of which raw materials it uses, helping ensure a consistent product that meets with the requirements of industry customers.
This approach, coupled with the use of hide as a source, fits with the US Food and Drug Administration’s (FDA) guidance on the use of gelatin in pharmaceutical products in light of concerns about bovine spongiform encephalopathy (BSE).
Current agency guidance states that as long as manufacturers ensure the hides are not contaminated with brain, spinal cord, or ocular tissues “there does not appear to be a basis for objection to the use of gelatin produced from bovine hides from any source country.”
Originates already has extensive experience in South America through its manufacturing and distribution operations in Columbia and Ecuador for it omega-3 fish oils business.