MISSOULA, Mont. (February 14, 2007) – TSI Health Sciences, a leading developer of high-end ingredients, announced today that its wholly owned manufacturing operations, Jiangyin TSI Pharmaceutical Co Ltd in Jiangsu, China has been granted approval from Australia’s Therapeutic Goods Administration (TGA) for the production of Chondroitin Sulfate Sodium.
In addition, the TGA has verified and approved the company’s TSI-Yangzhou Natural Products Co., Ltd. for glucosamine production, and as was the case with Jiangyin TSI Pharmaceutical Co Ltd, the agency audited manufacturing and supply processes thoroughly according to current ICH Good Manufacturing Practices for Active Pharmaceutical Ingredients before granting the approval.
The audit and inspection by Australia’s regulatory authority takes to a new level of verification, the quality control measures and commitment implemented by TSI Health Sciences. The approvals allow TSI Health Sciences to actively pursue world-wide drug business with those companies that require that level of certification.
“We’re now positioned to compete with the elite on a global basis”, observed Larry Kolb, TSI Health Sciences president, U.S. operations. “Being able to pursue drug business as a result of these recent certifications represents huge potential from a business perspective, but it also differentiates our philosophy as an ingredient supplier. The TGA process is among the most stringent in the world. It means we have absolute and total control of our manufacturing processes. It reinforces our USP (United States Pharmacopoeia) ingredient certification for chondroitin sulfate, and where consistent supply of highest quality, safe ingredients is an issue, we should be at the table. Our clients pursuing both supplement and drug business can have the utmost confidence in TSI Health Science products meeting the most rigorous quality parameters anywhere,” Kolb concluded.
TSI Health Sciences
TSI Health Sciences, www.tsiinc.com, has evolved throughout the last decade to focus primarily on in-house, high-end ingredient production and has become a leading developer, producer and marketer of nutraceutical ingredients to the dietary supplement, pharmaceutical and food and beverage industries. With US operations based in Missoula, Mont., TSI was founded in 1996 and has offices worldwide, including a 60-acre, fully integrated manufacturing, research, quality assurance and quality control campus in Jiangyin, China. The company's comprehensive product range includes botanical, marine and natural product extracts, as well as synthesized compounds. TSI guarantees full-service cGMP manufacturing through TSI Manufacturing Systems, with divisions specializing in small and large-scale botanical and natural product extraction, large-scale chemical synthesis production and secondary processing capabilities.
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For more information, contact:
Larry Kolb, President