Sandoz responds to FDA warning letter

Sandoz responds to FDA warning letter

Holzkirchen, June 04, 2013
Sandoz and Novartis announced today that the U.S. Food and Drug Administration (FDA) issued a Warning Letter concerning the company's Unterach, Austria site.

The warning letter observations by the FDA follow an agency inspection at the site in October 2012, and are related to visual inspection of products manufactured at the site. The site became part of Sandoz and Novartis through the acquisition of EBEWE Pharma in 2009. 

"We take seriously the warning letter observations cited by the FDA and will work closely and expeditiously to address these concerns to the agency's full satisfaction," said Ameet Mallik, Sandoz' Head of Biopharmaceuticals & Oncology Injectables.  "Sandoz has made strong progress in strengthening operations in Unterach through significant investments in both resources and state-of-the-art technologies. We remain deeply committed to fully addressing all outstanding issues and meeting all quality standards."

Providing patients with high-quality medicines is the company's highest priority.  Since 2011, Sandoz is not aware of any adverse events in products manufactured at the Unterach site associated with the observations in the letter. The company does not anticipate any related product supply issues at this time.  

About Sandoz

Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the rapidly growing generics industry. Sandoz offers a broad range of about 1,100 high-quality, affordable products that are no longer protected by patents. With nearly 26,000 employees in approximately 140 countries, Sandoz holds the #1 position globally in biosimilars, injectables, ophthalmics and dermatology as well as a strong global #5 position in inhalables. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments, and hormone therapies. Sandoz develops, produces, and markets these medicines along with pharmaceutical and biotechnological active substances and anti-infectives. In addition to strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US). In 2012, Sandoz posted sales of USD 8.7 billion.

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For further information

Sandoz Global Communications:
Neil Moorhouse
+49 8024 476 2597; [email protected]

Sandoz Global Communications:
Sreejit Mohan
+49 8024 476 2550; [email protected]

Sandoz Global Communications:
Michael Amos
+49 8024 476 2896; [email protected]