SAFC Officially Opens New $30 Million High Potency API Facility in Madison
SAFC, a member of the Sigma-Aldrich® Group (NASDAQ: SIAL), today announced the opening of a $30 million expansion to its Madison manufacturing facility in Verona, Wisconsin. Designed to significantly increase the capacity to produce commercial scale high potency active pharmaceutical ingredients (HPAPIs), the 51,000ft² expansion was unveiled at an official ceremony attended by Wisconsin state governor Jim Doyle, mayor Jon Hochkammer from the City of Verona and secretary Dick Leinenkugel from the Wisconsin department of commerce.
The new facility complements SAFC’s existing 63,000ft² HPAPI site in Madison and houses commercial scale reactors capable of producing HPAPI batch sizes up to 4,000 liters, which is up to 10 times greater than the capacity of the Madison site. Constructed specifically to support pharmaceutical manufacturers with their Phase III and commercial HPAPI needs, the Verona plant features the same state-of-the-art facility design and containment engineering as the Safebridge® certified Madison facility on a larger scale.
The site is designed to maximize efficiencies and safe handling in high potency development and to adhere to Category IV standards, the highest guideline for HPAPI handling and containment. The facility includes state-of-the-art development laboratories, a 150-liter mini-processing plant and two large-scale cGMP manufacturing suites. Specially designed quality control laboratories, a potent compound packaging area and warehouse and office space, plus expansion space, are also featured in the building.
“With the high potency market continuing to experience double-digit growth and ongoing significant advances in clinical pharmacology and oncology, there is a significant need for the large-scale production of HPAPIs,” said Gilles Cottier, SAFC president. “This new facility represents a significant step toward addressing that market demand and supports SAFC’s desire to maintain a leadership position in commercial scale high potency manufacture.”
At the opening ceremony, governor Doyle stated, “Sigma-Aldrich continues to invest significantly in the state of Wisconsin and we are delighted that they have chosen this location for what is a truly world class facility. I am also pleased that 45 to 50 jobs will ultimately be created as a result of its construction.”
The foregoing release contains forward-looking statements that can be identified by terminology such as ‘significantly increase its capacity to produce,’ ‘maximize efficiencies,’ ‘represents a major step,’ ‘maintain a leadership position’ or similar expressions, or by express or implied discussions regarding the Madison facility and its products, or regarding potential future revenues from information derived therefrom. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements.
There can be no guarantee that produce manufactured at the Madison facility will continue to meet the demands of the marketplace. Nor can there be any guarantee that the products manufactured at the Madison facility will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding the new Madison facility could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the Company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Company’s assets and liabilities as recorded in its consolidated balance sheet, and other risks and factors referred to in Sigma-Aldrich’s current Form 10-K on file with the US Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Sigma-Aldrich is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.