Ipca's small-scale API producer in U.K. expanding

India's Ipca Laboratories is facing FDA regulatory actions at plants in India, but the drugmaker's small-scale API and CRO operation in the U.K. intends to again increase capacity, this time by about 30%.

Onyx Scientific is investing in a new facility at its site Northeast England, the company says in a statement. The expansion will primarily be used to expand GMP suites and labs but the company also intends to use some of the space for storage of GMP materials. The expansion follows another last year as demand for the manufacturing increased, the company said.

"The decision to expand into an additional building has been driven by increased demand for GMP services as well as continuous flow projects and solid state chemistry, which has fully utilized our resources over the past 12 months," Denise Bowser, commercial director at Onyx Scientific, said in a statement.

Onyx's parent Ipca reported this week that the FDA has issued it a warning letter for three of its Indian plants that had been placed last year on the FDA import alert list. The plants were actually tagged for concerns during inspections in 2014 and none of them have shipped products to the U.S. since then. Ipca said Monday in a filing to the Bombay Stock Exchange that it has already laid out its remediation plan for the FDA and has been working with outside consultants to help get the facilities back on track.

- read the statement

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