Joseph Keenan

Eurofins CDMO Alphora has expanded its Mississauga, Canada, facility with additional development and production suites covering 627 square feet to meet rising demand for non-potent and high-potency active pharmaceutical ingredients. The expansion includes walk-in fume hoods supporting reactors of up to 100 liters, an analytical laboratory, a GMP warehouse and expanded kilolab capacity. The site employs about 250 people and will support the production of linkers and payloads for the company’s integrated antibody-drug conjugate offering. The project follows Eurofins’ 2024 launch of a $64.1 million, 50,000-square-foot facility for monoclonal antibodies and protein therapies; financial details for the latest expansion were not disclosed.

Maja Pedersen has been appointed president of Fujifilm Biotechnologies while retaining her chief operating officer role, following the retirement of the CDMO’s CEO title. Former CEO Lars Petersen will remain as a strategic advisor through September, while chairman Toshihisa Iida continues overseeing alignment with Fujifilm Holdings’ global strategy. Pedersen, who previously led quality at Fujifilm Biotechnologies and external manufacturing at Biogen, will focus on quality, operational excellence, customer delivery and growth. The leadership change comes as the company expands major manufacturing capacity, including its $3.2 billion antibody-focused cell culture facility in Holly Springs, North Carolina.

German packaging company Gerresheimer is selling Centor US Holding and its Primary Packaging Plastics division to private equity group Apax Partners in transactions valued at €1.5 billion. The Centor deal is expected to close by the end of 2026, while the Primary Packaging transaction is expected to conclude by the end of 2027. Gerresheimer plans to use the proceeds to reduce debt and strengthen its capital structure after reporting a €318.7 million net loss in 2025, amid a BaFin investigation, acquisition-related debt and weaker demand. The divestments are also intended to refocus the company on drug delivery, medical devices and injectable-drug packaging.

Baxter International is voluntarily recalling one U.S. lot of cefazolin in dextrose injection after cardboard was found in an IV infusion bag. The affected lot, LD175708, expires in February 2027 and was distributed nationwide between March and June 2025. Baxter warned that contaminated particles could block blood vessels, activate the immune system, impair organs and cause blood-cell breakdown, although no related adverse events had been reported as of July 24. The recall follows earlier safety issues involving Baxter’s Novu IQ infusion pump administration set, which were linked to 79 serious injuries and two deaths.

The FDA issued separate warning letters to Indian API manufacturers Almon Healthcare and Shimoga Chemicals following inspections that found serious manufacturing and quality-control deficiencies. Almon was cited for failing to identity-test raw materials, accepting deliberately mislabeled materials to circumvent licensing requirements, inadequately validating testing methods, and using contaminated equipment. Shimoga was criticized for weak analytical-data controls, inadequate sampling and records, unverified testing methods, insufficient process validation, and poor cleaning of non-dedicated equipment used to produce clomiphene citrate for U.S. pharmacy compounding.

Lupin Pharmaceuticals, the U.S. unit of India’s Lupin Limited, is voluntarily recalling more than 2.5 million bottles of prednisolone acetate ophthalmic suspension after the discovery of an unspecified foreign substance. The prescription steroid eye drops were manufactured in Pithampur, India, distributed across the United States, and sold in 5-, 10-, and 15-milliliter bottles. The FDA classified the action as a Class II recall, and no related adverse effects had been reported as of the latest enforcement update. The recall follows earlier quality and product-effectiveness concerns involving Lupin, while the company is also planning a proposed $250 million manufacturing facility in Florida.