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Press release from PR Newswire

SAFC® Manufacturing New High-Quality PharmaGrade Raw Materials at Arklow, Ireland, Plant

Wednesday, October 16, 2013

SAFC® Manufacturing New High-Quality PharmaGrade Raw Materials at Arklow, Ireland, Plant

07:00 EDT Wednesday, October 16, 2013

ST. LOUIS, Oct. 16, 2013 /PRNewswire/ -- Sigma-Aldrich Corporation's (NASDAQ: SIAL) custom manufacturing services business unit, SAFC® Commercial (www.sigma-aldrich.com/safc), has broadened production at its Arklow, Ireland, facility to include new PharmaGrade products. Production of the raw materials began at the site earlier this year and complements the existing offering of highly regulated active and non-active pharmaceutical ingredients manufactured at the site. All products manufactured at the Arklow facility meet and exceed U.S. Food and Drug Administration (FDA) regulations; follow Current Good Manufacturing Practices (cGMPs) for biopharmaceutical production; and comply with International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) requirements.

"Arklow was chosen for this expansion due to its existing specialized and highly regulated manufacturing capability," said James Ennis, Site Manager for SAFC's Arklow Facility. "All PharmaGrade products offer high purity and are manufactured under controlled processes. The PharmaGrade products from Arklow are manufactured under ICH Q7 guidelines."

The new PharmaGrade products manufactured at the Arklow facility include difficult-to-source materials available from research- to commercial-scale volumes. The program takes advantage of Arklow's purification, recrystallization and distillation competencies to manufacture a short list of catalog products in the PharmaGrade line, including benzyl alcohol, ethanolamine, fumaric acid, N-acetyl-DL-tryptophan, sodium benzoate, sodium butyrate and hexylene glycol. These specific products began transitioning to the Arklow facility in Q4 of 2011 and were then upgraded to meet PharmaGrade guidelines before production began this year. There are plans to further expand the PharmaGrade product offering from Arklow with D-galactose expected to launch in Q4 of 2013.

"With the addition of products being made in Arklow, the PharmaGrade line now encompasses just under 100 products that offer the right quality for our biopharma and pharma customers, as well as providing additional value through quality documentation packages, readily-available inventory and multiple batches to support customer qualification activities," said Douglas Bowman, SAFC's Program Manager for PharmaGrade.

SAFC's Arklow facility was originally purpose-built for products that require alkylation, esterification, ester condensation, reduction and Suzuki coupling, and features additional chromatography, crystallization and milling capabilities. With 64,000 cubic meters of space, the Arklow facility is fully cGMP compliant and has consistently passed FDA and Irish Medicines Board (IMB) inspections. It features four separate plants and has reactor capacity of more than 94,000 liters including glass-lined, as well as stainless steel reactors, distillation units, various dryers and ovens and controlled sieving, delumping and packaging space.

You can learn more about the Arklow, Ireland, SAFC facility by clicking here. Visit www.sigma-aldrich.com/safc-pharmagrade  for more information on the PharmaGrade product line.

The foregoing release contains forward-looking statements that can be identified by terminology such as "there are plans," "expected," or similar expressions, or by expressed or implied discussions regarding potential future revenues from products derived there from. You should not place undue reliance on these statements. There can be no guarantee that the products in SAFC's product offering will continue to meet the demands of the marketplace. Nor can there be any guarantee that any of these products will achieve any particular levels of revenue in the future. 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. In particular, management's expectations regarding these products 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.

About SAFC: SAFC Commercial, the custom manufacturing and services business unit of Sigma-Aldrich Corporation, is recognized as a top 10 global specialty chemicals and biologics supplier. As a trusted manufacturer for the life science and high technology industries, SAFC works closely with customers to resolve development challenges and accelerate the product pipeline utilizing its global "Centers of Excellence" and dedicated manufacturing facilities. Its rich portfolio includes high-purity inorganic materials for high technology applications, critical raw materials and extensive biologics safety testing services for biopharmaceutical manufacturing, and complex, high-potent APIs and key intermediates for pharmaceutical manufacturing. For more information, visit www.sigma-aldrich.com/safc.

About Sigma-Aldrich: Sigma-Aldrich is a leading Life Science and High Technology company whose biochemical, organic chemical products, kits and services are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development, the diagnosis of disease and as key components in pharmaceutical, diagnostics and high technology SAFC manufacturing. Sigma-Aldrich customers include more than 1.3 million scientists and technologists in life science companies, university and government institutions, hospitals and industry. The Company operates in 38 countries and has nearly 9,100 employees whose objective is to provide excellent service worldwide. Sigma-Aldrich is committed to accelerating customer success through innovation and leadership in Life Science and High Technology. For more information about Sigma-Aldrich, please visit its website at www.sigma-aldrich.com.

©2013 Sigma-Aldrich Co. LLC. All rights reserved. SAFC is a trademark of Sigma-Aldrich Co. LLC or its Affiliates, registered in the US and other countries. PharmaGrade is a trademark of Sigma-Aldrich Co. LLC.

SOURCE Sigma-Aldrich Corporation

For further information: SAFC INQUIRIES: Kristi Fortschneider, Marketing Communications Coordinator, + (314) 286-8331 x2407; MEDIA INQUIRIES: Beth Willers, Impress Labs, + (415) 846-9891, beth@impresslabs.com

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