Pharmaceutical packaging License for SCHOTT in China

SCHOTT Pharmaceutical Packaging in Suzhou, China, has now received the official license to manufacture and supply vials and ampoules to the Chinese pharmaceutical industry by China’s State Food and Drug Administration (SFDA).

The People’s Republic of China recently introduced a rather demanding approval process for suppliers of primary pharmaceutical packaging under the auspices of the “State Food and Drug Administration” (SFDA) in Beijing, an agency comparable to the Food and Drug Administration (FDA) in the United States. To be able to market their products in China, manufacturers who intend to enter the market now have to meet a broad range of strict requirements on material and processing quality. In setting such high standards, industry experts feel that China is setting a clear trend towards quality improvement of pharmaceutical packaging.

SCHOTT Pharmaceutical Packaging in Suzhou, China, has now received the official license to manufacture and supply vials and ampoules to the Chinese pharmaceutical industry by China’s State Food and Drug Administration (SFDA).

The People’s Republic of China recently introduced a rather demanding approval process for suppliers of primary pharmaceutical packaging under the auspices of the “State Food and Drug Administration” (SFDA) in Beijing, an agency comparable to the Food and Drug Administration (FDA) in the United States. To be able to market their products in China, manufacturers who intend to enter the market now have to meet a broad range of strict requirements on material and processing quality. In setting such high standards, industry experts feel that China is setting a clear trend towards quality improvement of pharmaceutical packaging.

“This is good news for our customers in the pharmaceutical industry, because higher quality packaging translates into better protection and storage of medications,” says Bernhard Elsener, Vice President Global Sales & Marketing at SCHOTT Pharmaceutical Packaging.

The Suzhou pharmaceutical packaging plant operates under the umbrella of the existing SCHOTT Glass Technology Company that was founded in 2002. The facility was built in accordance with the same high standards that SCHOTT pharmaceutical packaging production sites adhere to on a global basis, including state of the art production equipment, visual inspection systems, clean room environment and compliance with Good Manufacturing Practices (cGMP). The site in Suzhou also has access to the entire global research and manufacturing expertise that exists at SCHOTT. According to current plans, the plant will employ approximately 50 people.

According to Elsener, the facility uses SCHOTT “Fiolax” Type 1 borosilicate glass, a high quality tubing glass that complies with international standards (USP, EP, and JP) to produce the complete range of ampoules and vials that the Chinese market is currently demanding. Only a few weeks ago, SCHOTT-Rohrglas had become the world’s first certified importer of Type 1 glass tubing in China. All packaging products satisfy the highest international requirements for pharmaceutical primary packaging made of glass and therefore put SCHOTT in the unique position of being able to support the growth of the high quality market segment.

“We can offer our customers a variety of tangible benefits. These include quick delivery, local customer support and services without language barriers, as well as full support from SCHOTT’s global network”, Elsener adds. The site in Suzhou will supply its high quality packaging products to both new and existing customers in China, many of whom have been accustomed to receiving deliveries from various other SCHOTT sites in the past. In addition, the plant will serve as a backup facility for the sister plant SCHOTT Igar Glass in Indonesia.

By obtaining official authorization to manufacture pharmaceutical packaging for the Chinese market, SCHOTT has taken a decisive step towards reinforcing its global presence and improving its position as one of the world’s leading suppliers of parenteral packaging for the pharmaceutical industry.