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What’s New at SST Corporation

GDUFA
SST is working closely with all of our Supplier Partners to ensure that they are compliant with the new GDUFA regulations. We anticipate that all of the Suppliers that we represent will meet each GDUFA mandated deadline. For additional information, please contact your SST representative.

Erregierre Successfully Audited By US FDA
Erregierre announced it successfully underwent a 4-day US FDA inspection from May 17-20, 2010. Manufacturing sites at San Paolo d'Argon and Sovere in Bergamo, Italy were both judged in compliance with the profile class covered during the inspection. Confirmation came from the FDA in late September that the Establishment Inspection Report (EIR) review had been completed, and Erregierre remains in compliance with current good manufacturing practices (cGMPs).

This result confirms, once again, the high level of compliance that represents one of the key assets of Erregierre, which is committed to supplying a wide range of pharmaceutical active ingredients to the worldwide pharmaceutical industry.

Shilpa Medicare Limited Receives EU GMP Approval from Afssaps
The following was an independent announcement by SST partner, Shilpa Medicare Limited:

Shilpa Medicare Limited successfully underwent a 2-day inspection by The French Health Products Safety Agency (Afssaps), ending on March 10, 2010. The Oncology manufacturing site located at Deosugur Industrial Area was considered to be in full compliance with the principles of Good Manufacturing Practice (EU GMP Part II) for the active substance Gemcitabine Hydrochloride. This outcome marks another milestone in compliance, reflecting Shilpa Medicare Limited’s continued commitment to supplying high-quality pharmaceutical active ingredients to the highly regulated markets of the European Union.

SST receives award
SST Corporation received a supplier award from Banner Pharmacaps, Inc. in May 2009.
Read the full story.

Upcoming Events
SST is attending CPhI 2010, October 5-7, at Paris Nord Villepinte, France.

Please contact us to arrange a meeting with one of our representatives.

New Products
SST now offers Colesevelam, Progesterone, Ezetimibe, Imatinib, Cinacalcet and Salmon Calcitonin for customers in the United States.

Patented products available for R&D use as permitted under 35 USC ¶ 271 (e) (1).

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