WHO needs replacement birth control API manufacturer

The World Health Organisation (WHO) is seeking a new manufacturer of the active pharmaceutical ingredient (API) for levonorgestrel, the birth control drug, after the FDA placed the Chinese manufacturer on import alert.

At the beginning of March, Qinhuangdao — the Chinese manufacturer of the API for levonorgestrel — was placed on import alert after the FDA found failures in the level of adherence to current good manufacturing practice (cGMP). “At the moment, there is no alternative levonorgestrel API which has been prequalified,” stated WHO.

Additionally, WHO is requesting that finished pharmaceutical products (FPP) manufacturers of prequalified products using levonorgestrel manufactured by Qinhuangdao take additional measures to ensure batch quality. “Until further notice, procurement agencies may continue to procure FPPs that contain API produced at Qinhuangdao,” reported WHO. The agency has not received any reports of quality issues on levonorgestrel tablets from the market so far.