- Small molecule manufacturer Cambrex Corp. is outfitting a recently opened facility in Milan, Italy, with new equipment that should ramp up R&D and production capabilities.
- The site, which was validated and ISO-certified last October, is getting a 2,800 liter hydrogenator, a centrifuge that measures 1.5 meters at its diameter and analytical equipment for crafting highly potent active pharmaceutical ingredient (HPAPI) — all of which Cambrex believes will provide "increased flexibility and capacity," according to an Oct. 12 statement.
- Cambrex expects the equipment installation and validation processes at the site will wrap up before next year. The East Rutherford, N.J.-based company has other manufacturing projects on its horizons as well, including a $24 million, 4,500-square-foot plant in Charles County, Iowa, meant for HPAPIs.
Between April and June, Cambrex saw its gross sales and net revenue increase roughly 13% year-over-year, driven largely by higher volume for innovator products and controlled substances. While the company has business in North America, Asia and other regions, two-thirds of the $134 million in gross sales it secured during the second quarter came from Europe.
Cambrex has maintained a foothold in Milan for some time, a company spokesperson told BioPharma Dive, but only recently opened the new pilot plant in the city's Paullo municipality.
The plant is compliant with current good manufacturing practices, built for churning out batches ranging in size from 1 kilogram to 15 kilograms. and focused on filling market demand for "small-scale API volumes, both for validation to support a DMF filing for Abbreviated New Drug Applications or generic registrations, and for API supply to niche markets, including ophthalmic drugs," according to a company statement from last year.
Though greater volume for innovator products has helped to boost bottom lines, Cambrex has identified generic manufacturing as a key growth opportunity — and one it hopes to take advantage of by expanding its footprint and capabilities.
"We have seen increased growth of activity among highly potent molecules in the past decade for use in therapeutics for cancer and other indications, and it is now becoming more appropriate in the generic API business as patents on these begin to expire,” Aldo Magnini, managing director of Cambrex Milan, said in the company's Oct. 12 statement.
"This investment is consistent with the Cambrex strategic plan to increase the company’s small molecule development and manufacturing capabilities, ensuring our facilities continue to meet the future demands of the industry," he said.
The added investment in Milan didn't seem to move investors, however. Cambrex shares were down less than 1% to $53.50 apiece on Oct. 12, and have since fallen to around $52.40.