Ingredient maker Dishman Pharmaceuticals has confirmed that it may offload its Chinese API (active pharmaceutical ingredients) factory.
Earlier this month Dow Jones Newswires reported that Dishman is in ‘advanced talks with a prospective buyer” for the facility at the Shanghai Chemical Industry Park, suggesting that failure to gain local regulatory approval promoted the move.
The newswire quotes company CFO V.V.S. Murthy as saying that: “If we get the price we are seeking, we’ll dispose it off and use the proceeds to reduce our debt.”
Dishman has pumped $20m (€15m) into the Shanghai plant since 2007, adding four segregated suites; two of which are dedicated solely to the production of category III HPAPIs (high potency API) with the plan being to supply drugmakers in Europe and the US.
The India-headquartered contract manufacturing organisation (CMO) originally predicted that the facility would gain Chinese Food and Drug Administration (SFDA) approval for manufacturing in September 2008.
However, according to Dishman spokesman Christian Dowdeswell SFDA approval was not achieved in line with the expected timescale, which prompted the firm to start examining its options.
He told in-PharmaTechnologist.com that: “It is estimated that it will take up to 3 years for the SFDA to grant GMP status” adding that “Dishman is therefore working on two options.
“The first option is to retain the Shanghai plant for the production of category III HAPI (Safebridge Category III) and the second option would be to divest the Shanghai plant and focus on API manufacture in India."