Monthly Archives July 2016

Our Contract Manufacturer of Procaine Hydrochloride Certified By FDA Again With 0-483!

From July 25 to 28, 2016, our contract manufacturer-Chongqing Southwest No.2 Pharmaceutical Factory (hereinafter referred to as ‘SW#2’) passed the U.S. FDA GMP onsite audit with excellent performance. And this was the second time that SW#2 received the highest international standards of quality certification after the first time in 2012. It represented SW#2 became the only procaine hydrochloride manufacturer which passed the United States FDA certification.

In present times, FDA carries out increasingly strict inspections to Chinese pharmaceutical industry and data integrity problems frequently emerge, it is really difficult to reach the “0-483” conclusion. This is the inevitable result of SW#2 firm implementation of cGMP management, technological progress and internationalization strategy, it reflects the strong international competitiveness of their products and lays a solid foundation for their products accessing to the US and European high-end markets. This is also the result of working closely together with Pharmax (Zjpharma) and the long-term win-win model of inter-firm cooperation.

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  Jul 29, 2016   Dynamic News, Uncategorized   Read More

Rainbowlabs passed the U.S. FDA on-site inspection again with Zero 483!

From 27th to 30th June 2016, the inspector of U.S. FDA (Food and Drug Administration) carried out on-site inspection to Shijiazhuang Rainbowlabs Pharmaceutical Technology Co., Ltd (hereinafter referred to as Rainbowlabs) and made Zero 483 conclusion on the date of 30th June. It signifies the Rainbowlabs has passed the U.S. FDA audit again with full marks.

In present times, FDA carries out increasingly strict inspections to Chinese pharmaceutical industry and data integrity problems frequently emerge, it is really difficult to reach the ‘zero 483’ conclusion.

The U.S. FDA is recognized as the most authoritative and strictest global pharmaceutical quality control organization. In July 2013, Rainbowlabs firstly passed the FDA on-site inspection with Zero 483 and became the first high tech company who passed FDA inspection as a third party testing laboratory. Today, Rainbowlabs’ outstanding performance with Zero 483 proved the professionalism of our quality system and detection system. It marks Rainbowlabs has reached the highest international standards of GMP benchmarking Enterprise.

Rainbowlabs passed the U.S. FDA inspection again, which will play a significant and promoting role to help domestic pharmaceutical companies to overcome technical & trade barriers and access to European and American high-end medical market. At the same time, we will set a new quality standard for Chinese bio-pharmaceutical industries in accordance with the highest international standards of quality to proceed new products development and new technology research.

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  Jul 01, 2016   Dynamic News   Read More