This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

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

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.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG

Markets

Chart of I:DJI
DOW 16,643.01 -11.76 -0.07%
S&P 500 1,988.87 +1.21 0.06%
NASDAQ 4,828.3250 +15.6170 0.32%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs