Manufacturers

Cambrex is accelerating API capacity expansion across the US and Europe, advancing a $120m Iowa project and a $30m Milan upgrade as it builds scale in complex chemistries, peptides and high-potency manufacturing amid rising reshoring demand.

“In a very siloed organization made up of a jigsaw of different companies, no one was thinking enterprise first,” says Perrigo CEO Patrick Lockwood-Taylor. “The fundamentals of running operations, brand-building, innovation, they are now as they were.”

Antonio Martinez Descalzo has more than 20 years' experience in life sciences, health and nutraceutical industries, including with food and beverage giant ADM. Israeli firm has completed pilot production and is moving into full manufacturing.

Sandoz has struck a new deal with Samsung Bioepis covering up to five early-stage biosimilars, expanding an existing alliance as the Swiss-based firm ramps up investment, reorganizes its business and targets a wave of upcoming biologics loss-of-exclusivity opportunities.

FY 2026 OMUFA facility fees are $19,188 for OTC monograph drug manufacturers and $12,792 for contract manufacturing organizations also making the products. FY 2025 fees were $37,556 and $25,037.

Industry continues to oppose domestic manufacturing incentives that the FDA wants to include in the PDUFA reauthorization.

Including OTC studies in special protocol assessments will be addressed in FDA guidance required in 15 months on improving predictability of process and standards for approval of OTC drug applications, while stepwise labeling information will be post online to improve visibility and searchability fo

In 2026, the Danish inspectors plan to focus on whether drug manufacturing procedures still match the approved marketing dossier, and will require wholesalers to show that the computerized systems used in distribution are fit for purpose.

“The president is certainly hamstrung in many ways by this ruling. For businesses, there's still just sort of a lot of general uncertainty in regard to what else is the president going to try to do, what other authorities might he try to pull,” says Tax Foundation analyst Alex Durante.

Kenvue’s full-year net sales 2.1% dip to $6.38bn came largely on a 2.2% organic sales decline driven by a 2.3% volume decrease but slightly offset by 0.2% foreign currency benefit.

NPA appoints SVP membership; Edible Brands promotes Angela Johnson to CMO; happyactually has medical chief; Nowadays adds reg affairs director; doTerra appoints EVP, innovation; RäFoods names president/CEO; Genesis Lifestyle Medicine adds VP operations; and Hany Salama leads Nutra-Med Packaging.

“Your firm’s quality systems are inadequate” or “these products are unapproved new drugs” each firm warned with reference to FDA’s regulation for GMPs for pharmaceuticals, supplements or cosmetics. Warnings included 10 to firms about GMP violations topical drugs production.