Livingston, United Kingdom, 21st November 2008

 

Encap Drug Delivery, the leading provider of development and manufacturing services to the pharmaceutical industry, has received official notification from the US Food and Drug Administration (FDA) that its facility is now classified as acceptable based on the facility inspection which took place earlier this year.

 

Encap’s state-of-the-art facility in the UK is the world’s largest development and manufacturing facility dedicated to liquid filled hard capsules.  The company has 20 years experience of providing formulation, clinical and commercial manufacturing services to companies worldwide and is already the approved manufacturing site for 8 products that are commercially licensed in Europe.  The FDA decision will enable Encap to work with companies who already have products on the US market or are seeking to launch products there in the future.

 

“Following our first ever pre-approval inspection earlier this year, we are delighted that Encap Drug Delivery has received notification that the facility is ‘classified as acceptable’ by the FDA.” said Encap’s Chief Operating Officer, Dr. Stephen Brown.  “This is a significant achievement for Encap Drug Delivery and a key milestone as we start to increase our focus on the US market." 

 

Encap’s facility already has full approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom and holds licences for the manufacture of Investigational Medicinal Products (IMPs) and commercial products.

 

The company has recently invested $5million in the UK facility enabling it to provide both clinical development and commercial scale manufacturing for companies developing highly potent or cytotoxic drugs.  “With our continued investment in the facility, the advanced, high quality infrastructure of Encap can meet the stringent challenges set by the most regulated markets of the world.” said Dr. Brown.

 

Liquid fill hard capsule technology is one of the fastest growing sectors of the drug delivery market, increasing at a rate of 30% per annum. The technology offers a solution to pharmaceutical companies facing difficulties in obtaining adequate and reproducible absorption from the gastrointestinal tract after oral administration, as the bioavailability of many drugs can be enhanced using liquid fill formulations.  The technology is also ideally suited to the vast number of oral anti-cancer treatments being developed today as it offers a safer and more reproducible manufacturing process.

 

About Encap Drug Delivery

Encap was established in 1989 and is a global provider of oral drug delivery and pharmaceutical development services.  The company is the acknowledged world leader in the speciality technology of liquid filled hard capsules and provides clients with fully integrated analytical and formulation development services, clinical trial manufacturing and high volume commercial manufacturing. 

 

Encap also provides a range of proprietary formulation and encapsulation technologies which can be used for new product concepts or to extend the life cycle of existing brands. DuoCap™ and LayerCap™ for controlled release combination products and Abusolve™ for controlled drug products are three examples of novel encapsulation technologies that have been developed.  Encap also has expertise in the development and application of enteric coating technologies and has developed and patented a proprietary food grade enteric coat.