Yongxin Pharmaceuticals (1716) today announced that it passed the FDA factory inspection again with zero 483 missing. After the completion of this factory inspection, the company will continue to sell products in the United States and accept the entrustment of IMPAX and the United States Pharmaceutical Factory. The new products can also be sold in the United States market. It is expected that the company's export sales performance will also have significant growth opportunities.
Form 483 indicates that the defects registered by the FDA factory inspection personnel need to be improved at a specific time and then reviewed by FDA.
The company said that the factory inspection was the most severe challenge in the company's history. In 2009, FDA officials inspected 18 pharmaceutical companies, 15 of which were issued Form 483, and more world-class pharmaceutical companies were issued a warning letter.
The FDA official used a variety of unique audit techniques to verify the consistency and control ability of the factory's production process one by one for a total of five days. Finally, in the summary meeting, he affirmed the company under investigation with no 483 missing. During the five-day inspection, FDA officials affirmed Yongxin and the inspected team with the words "Great Company, Great People", confirmed that Yongxin's GMP has reached the international standard, and indeed prepared for the corporate vision of globalization.
Yongxin's turnover last year was 3.267 billion yuan, up 3% compared with the previous year's turnover, and the long-term investment benefits gradually showed up, accounting for about 35% of the company's surplus; China Kunshan Yongxin Pharmaceutical Factory passed the FDA inspection of the United States in March 2009, and obtained the first company certified in China. At the same time, Yongxin also passed the PIC/S GMP certification on July 24, 2009, and passed the PMDA inspection entrusted by the Ministry of Health and Welfare of Japan. The level of drug GMP management system is sufficient to meet the international standards.
