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Schott becomes first importer to be certified by Chinese FDA

Based in Mitterteich, Germany, SCHOTT-Rohrglas GmbH is now officially authorized to export “Fiolax” specialized glass tubing to China that can then be processed into ampoules, cartridges, vials and syringes. Due to its high hydrolytic stability and ease of processing, customers all over the world consider this specialized glass from SCHOTT to be an ideal starting material for premium quality primary pharmaceutical packaging.

SCHOTT has been supplying “Fiolax” specialized glass tubing to China for four years now. The total market for pharmaceutical glass tubing is estimated to be more than 150,000 tons. Today the premium segment for high-quality packaging is still relatively small. But it is expected grow strongly within the next years.

“This certification is extremely important for us, because it underscores to our customers in China that we meet China’s demanding requirements for quality with our products,” explains Peter Scherer, Vice President Marketing & Sales at SCHOTT-Rohrglas.

The State Food and Drug Administration (SFDA) in the People’s Republic – comparable to the Food and Drug Administration (FDA) in the United States – is currently implementing an ambitious licensing procedure for pharmaceutical products and setting the highest possible standards for quality. “In our opinion, China is sticking to its quality-oriented course very consistently. We appreciate this, due to the fact that demands for food and pharmaceutical drug safety can hardly be set high enough,” Scherer says.

Experts expect double-digit growth in pharmaceutical packaging to continue in China over the next few years. “The fact that we are the world’s first supplier to become certified in China underlines the strategic importance of this market. In addition, it demonstrates how we are seeking to establish enduring customer relationships in China,” Scherer says.