Taro Resolves FDA Warning Letter
Regarding Canadian Manufacturing Facility
HAWTHORNE, N.Y.--(BUSINESS WIRE)--Apr 25, 2011 - Taro Pharmaceutical Industries Ltd. (“Taro” or the “Company”, Pink Sheets: TAROF) today announced that the U.S. Food and Drug Administration (“FDA”) has informed the Company that after a February 2011 re-inspection of its Canadian manufacturing facility, the site has an acceptable regulatory status. Therefore, the issues noted in the February 5, 2009 warning letter are considered to be resolved.
“We have worked diligently at the Brampton facility to resolve the issues noted in the last inspection and are pleased that our efforts have brought the facility back into good standing with the Agency. We are dedicated to developing and manufacturing quality products for our customers while meeting and exceeding all Good Manufacturing Practices (GMP) standards set by the FDA and Health Canada,” said James Kedrowski, Interim Chief Executive Officer of Taro.
Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products. For further information on Taro Pharmaceutical Industries Ltd., please visit the Company's website at www.taro.com.
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements that do not describe historical facts and statements that refer or relate to events or circumstances the Company "estimates," "believes," or "expects" to happen, "should" happen, or similar language. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurances that its expectations will be attained. Factors that could cause actual results to differ include regulatory actions taken by the FDA, general domestic and international economic conditions, industry and market conditions, changes in the Company's financial position, regulatory actions, and other risks detailed from time to time in the Company's SEC reports, including its Annual Reports on Form 20-F.
Contact: Taro Pharmaceutical Industries Ltd.
William J. Coote, 914-345-9001
VP and Treasurer
Posted: April 2011