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TPI > SEC Filings for TPI > Form 8-K on 7-Apr-2014All Recent SEC Filings




Other Events

Item 8.01. Other Events

As an effort to expand generic market amid the pricing pressure of its generic division, Tianyin Pharmaceutical Inc. (the "Company" or "TPI") has explored the strategic reduction of the tendering price of its Hugan Tablets (for liver conditions, approximately $0.6 million sales per year) in order to compete in Zhejiang province of China. The competitive tender price has helped TPI to successfully secure the right of sales for Hugan Tablets in Zhejiang province. However, as a part of the government's regulatory procedure, the China Food and Drug Administration (the "CFDA") normally conducts examination on the production process and the cost of sales for competitive (low) tendering price bidders. Currently TPI is under such examination for quality and pricing tests that are conducted by the CFDA of Sichuan province. During the examination period, the Company's Good Manufacturing Practice ("GMP") certificate granted by the CFDA on August 27, 2013 is being administrated by Sichuan provincial CFDA and the sale of our Hugan Tablets are temporarily halted, pending the results of quality and pricing tests. We expect the tests will be completed in late April. Management is confident that TPI will pass the quality and pricing tests successfully and be able to resume sales of Hugan Tablets.

The Company is currently assessing the impact on sales of Hugan Tablets as a result of this event, as well as indirect impact on the sales of our other generic products, if any. We will promptly file an amendment to this Form 8-K when a status update is available.

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