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Italy’s Flamma quadruples R&D space to support API production in U.S.

Italian contract development and manufacturing organization Flamma SpA has spent the past three years boosting its pharmaceutical ingredient business in China, Italy and the U.S. Now, it’s breaking ground at a massive R&D facility on the company’s home turf.

The new facility on Flamma’s headquarters campus in Chignolo D’Isola, Italy, will quadruple its R&D space, the company said in a release, and provide enough real estate for 50 new employees. The building will house R&D and analytical development labs, plus offices and meeting rooms. High containment and special chemistries labs will round out the site. 

It will also complement R&D work at Flamma’s American site in Malvern, Pennsylvania, and help it amp up active pharmaceutical ingredient (API) production there at a time when officials are calling for stepped-up drug manufacturing on U.S. soil. Flamma makes several generic drugs, key intermediates and more, but one of its chief businesses is small molecule APIs.

Flamma bought the Philadelphia-area facility from Teva Pharmaceuticals last year—one of three Good Manufacturing Practice (cGMP) facilities the company established ahead of the new Chignolo project. But the company had a headquarters expansion in its sights from the start, even as it grew its network beyond Italy.

In March 2019, when the company announced its Flamma Honkei site in Dalian, China had passed a Chinese FDA (CFDA) inspection, it was quick to point out that the expansion into Asia was a step toward a broader R&D overhaul. At the time, Flamma said it planned to plow $20 million into R&D buildings over the next two years and earmarked $9 million for the new HQ building.

On the same day, Flamma finished construction of its first cGMP Kilo Lab in Chignolo, and a few months later, the CDMO snatched up Teva’s Chemical Synthesis Center outside of Philadelphia to cater to its customers in the U.S.

The site pivoted to make active pharmaceutical ingredients (APIs), and the company made plans to grow the site by 60 employees by 2023. That facility—the company calls it “Flamma-Delphia”—will work in tandem with the Chignolo site once construction is done. 

As Flamma wraps up its push to boost R&D capacity, the pharma industry has been thrust into unfamiliar territory by COVID-19. Many drugmakers source their pharmaceutical ingredients from China and India, and as the novel coronavirus wreaks havoc on global supply chains, several Big Pharma executives have called for greater API manufacturing power close to home. 

For its part, Flamma said its employees in Italy and China have worked tirelessly to supply drugmakers with the vital ingredients they need to make COVID-19 treatments and vaccines.