US FDA warns compounders of contaminated baclofen API from China

By Dan Stanton

- Last updated on GMT

Photo - iStock
Photo - iStock

Related tags Pharmaceutical drug Us

The US FDA has alerted compounders of potential particulate matter in an API sourced from Chinese drugmaker Taizhou Xinyou Pharmaceutical & Chemical.

Certain lots of baclofen active pharmaceutical ingredient (API) manufactured by Taizhou from its facility in Zhejiang, China could be at risk for contamination with particulates, the US Food and Drug Administration (FDA) said in safety alert issued Saturday.

Baclofen is used as a central nervous system depressant, and the firm supplies a number of US compounding facilities which were recommended not to use the API after Taizhou “confirmed that, due to the level of controls in the manufacturing process, the baclofen API it manufactures is not suitable for use in injectable drugs,”​ the Agency said.

“The affected API may potentially pose serious safety risks for US patients who use or receive injectable drug products compounded with the affected baclofen, especially when administered directly into the spinal column.”

The FDA continues to investigate the issue.

Chinese Activities

Taizhou was established in 1995 and manufactures various APIs including phenibut, sodium sulbactam, and nomegestrol, according to chemical sourcing website​. Efforts to contact the firm for more information by this publication proved unsuccessful.

Contaminated crude heparin sourced by a number of Chinese ingredient makers is suspected to have caused more than 80 deaths in the US in 2008​, and tarnished the reputation of the Chinese API industry.

The industry has recovered and China continues to be a major source of APIs for the US and worldwide. However, the Taizhou alert is the latest regulatory action in China over the past few weeks.

Pfizer’s facility in Dalian, north China, received an FDA Form 483 citing various violations of GMP, including the firm hiding documents “inside a crate”​ and one plant having just “one stand-alone toilet in significant disrepair, 50 yards from the aseptic manufacturing unit.”

And in Tianjin, fellow Big Pharma firm GSK had its GMP certificate revoked by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA)​ after a June inspection at its plant uncovered “a critical deficiency”​ related to stability problems with some of the non-sterile products made there.

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