Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
News|Articles|June 19, 2019
Catalent to Purchase BMS Manufacturing Site in Anagni, Italy
Author(s)Pharmaceutical Technology Editors
Catalent will manufacture products for Bristol-Myers Squibb while adding sterile biologics fill/finish and oral solids manufacturing and packaging capacity.
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Catalent has agreed to purchase Bristol-Myers Squibb’s oral solid, biologics, and sterile product manufacturing and packaging facility in Anagni, Italy. The 19,300-square-meter facility, located 100 kilometers southeast of Rome, opened in 1966.
The site is used to manufacture and package cardiovascular, neuroleptics, anticancer, metabolic and anti-inflammatory medicines, non-penicillin-based antibiotics, antivirals, and analgesics. Catalent reports it will continue to manufacture Bristol-Myers Squibb’s current product portfolio at the site.
The transaction is expected to be completed by the end of 2019, subject to regulatory approvals, consultation with the unions, and other customary closing conditions.
In a June 19, 2019 press statement announcing the pending sale, Catalent said the company will bring new customers to the site for biologics and oral solid-dose manufacturing and packaging; the facility will provide Catalent biologics customers with access to sterile drug product fill/finish and packaging capacity in Europe to complement the company’s existing capabilities in Belgium.
“The addition of the Anagni facility provides our European customers with great biologics and oral dose capabilities to accelerate their development programs and improve commercial supply,” said Alessandro Maselli, Catalent’s president and chief operating officer, in the press statement. “Bristol-Myers Squibb has invested in the facility to create a center of excellence for new product launches with a robust quality and delivery record, and an employee base who shares Catalent’s operational excellence and patient focus.”
“We believe that the sale to Catalent will continue the vital role the Anagni facility plays for its workforce, the community, and patients,” said Lou Schmukler, president, global product development and supply, Bristol-Myers Squibb. “This marks an important step in the ongoing evolution of our manufacturing network to support the company’s innovative product portfolio. Bristol-Myers Squibb has a long history in Italy, and we intend to maintain a continued strategic presence in Italy, which is critical for our ability to deliver transformational medicines to patients.”
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