Catalent Pharma Solutions Further Expands Its High Potency Handling Capability
Somerset, N.J. – January 28, 2015 — Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has today announced the expansion of potent handling and manufacturing capabilities at its Somerset, NJ facility. Together with recently announced investments in high potency clinical packaging, as well as the acquisition of Micron Technologies, this investment further expands Catalent’s extensive suite of solutions for high potency compounds, from optimization through clinical and commercial manufacturing of final dose form.
Catalent has completed the expansion of facility and engineering controls for its high potency tableting and OptiMelt™ Hot Melt Extrusion operations in Somerset to supplement existing potent capabilities in oral solid and Zydis® Fast Dissolve manufacturing. The company is now investing in additional potent containment for large scale blending, fluid bed processing, and high shear granulation, which will come online throughout the first half of 2015.
The expansion creates a manufacturing Center of Excellence for potent handling across Catalent’s portfolio of oral solid manufacturing solutions, which includes hot melt extrusion, high-shear and wet granulation processing, solvent-based capability, extrusion/spheronization, fluid-bed processing, Wurster coating, and compression and encapsulation.
“With the growing pipeline for oncology and other highly potent compounds, industry demand for development and manufacture is increasing,” commented Jonathan Arnold, Vice President and General Manager of Catalent’s Advanced Delivery Technologies business. “Catalent has extensive experience in potent compound handling, now providing analytical, development, manufacturing and packaging services for over 300 Category 3 & 4 potency compounds across our global network. Our continued investment demonstrates our commitment to providing comprehensive solutions across the entire drug development cycle.”
Catalent’s global potent manufacturing capability spans both oral and injectable dose forms, including a full suite of development and manufacturing services for traditional oral solids, Micron Particle Size Engineering, RP Scherer Softgel Technologies, Zydis Fast Dissolve, OptiMelt Hot Melt Extrusion, Blow-Fill-Seal, and ADVASEPT™ glass-free injectable technology. For more on these capabilities please visit www.catalent.com/potent.
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Catalent Pharma Solutions, is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,000 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in fiscal 2014 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
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Forward Looking Statements
This release contains both historical and forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally can be identified by the use of statements that include phrases such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “project,” “foresee,” “likely,” “may,” “will,” “would” or other words or phrases with similar meanings. Similarly, statements that describe our objectives, plans or goals are, or may be, forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Catalent, Inc.’s expectations and projections. Some of the factors that could cause actual results to differ include, but are not limited to, the following: participation in a highly competitive market and increased competition may adversely affect the business of the Company; demand for the Company’s offerings which depends in part on the Company’s customers’ research and development and the clinical and market success of their products; product and other liability risks that could adversely affect the Company’s results of operations, financial condition, liquidity and cash flows; failure to comply with existing and future regulatory requirements; failure to provide quality offerings to customers could have an adverse effect on our business and subject the Company to regulatory actions and costly litigation; problems providing the highly exacting and complex services or support required; global economic, political and regulatory risks to the operations of the Company; inability to enhance existing or introduce new technology or service offerings in a timely manner; inadequate patents, copyrights, trademarks and other forms of intellectual property protections; fluctuations in the costs, availability, and suitability of the components of the products the Company manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials; changes in market access or healthcare reimbursement in the United States or internationally; fluctuations in the exchange rate of the U.S. dollar and other foreign currencies; adverse tax legislation initiatives or challenges to the Company’s tax positions; loss of key personnel; risks generally associated with information systems; inability to complete any future acquisitions and other transactions that may complement or expand the business of the Company or divest of non-strategic businesses or assets and the Company’s ability to successfully integrate acquired business and realize anticipated benefits of such acquisitions; offerings and customers’ products that may infringe on the intellectual property rights of third parties; environmental, health and safety laws and regulations, which could increase costs and restrict operations; labor and employment laws and regulations; additional cash contributions required to fund the Company’s existing pension plans; substantial leverage resulting in the limited ability of the Company to raise additional capital to fund operations and react to changes in the economy or in the industry, exposure to interest rate risk to the extent of the Company’s variable rate debt and preventing the Company from meeting our obligations under our indebtedness. For a more detailed discussion of these and other factors, see the information under the caption “Risk Factors” in our 10-K for the fiscal year ended June 30, 2014, filed with the Securities and Exchange Commission. All forward-looking statements speak only as of the date of this release or as of the date they are made, and Catalent, Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except to the extent required by law.