Manufacturing & Packaging

In the fourth part of his Pharma Commerce video interview, Dave Malenfant, a healthcare supply chain expert, cautions that stockpiling to offset tariffs could backfire for pharma companies, leading to expired inventory, higher waste, and costly trade-offs, unless renegotiation strategies are pursued.

As of today, Aug. 27, wholesale distributors must fully comply with the Drug Supply Chain Security Act’s enhanced drug distribution requirements, closing the FDA’s exemption period and advancing efforts to strengthen patient safety and supply chain integrity.

This episode of Pharma Pulse covers the FDA’s new daily adverse event reporting initiative, the CDC’s appointment of an mRNA vaccine critic to lead its COVID-19 immunization workgroup, and Genentech’s $700 million investment in a North Carolina biologics facility.

The new 700,000-square-foot Holly Springs site—part of Roche’s $50 billion US investment plan—will focus on metabolic and obesity treatments, create 400 jobs, and strengthen domestic biopharma manufacturing amid shifting tariff and drug pricing policies.

An FDA Form 483 cited unaddressed contamination, pest infestations, and equipment failures at manufacturer’s Bloomington, IN facility, which was acquired in the Catalent buyout.

Addressing the most common concerns surrounding the legislation intended to establish interoperability within the pharma supply chain.

The new framework, set to take effect Sept. 1, limits tariffs on pharmaceutical imports to 15% but follows months of shifting proposals, including threats of tariffs as high as 250%.

In the fourth part of his Pharma Commerce video interview, Mark Lee, MarqVision’s founder and CEO, discusses how healthcare companies and regulators can strengthen defenses against counterfeit drugs by integrating AI with physical authentication methods and enabling secure, anonymized data sharing across the pharm sector.

The company will be heavily investing over the next decade to build a new biopharmaceutical facility in Holly Springs, NC, creating 120 jobs and reinforcing its $55 billion pledge to strengthen US manufacturing, R&D, and innovation.

In the third part of his Pharma Commerce video interview, Dave Malenfant, a healthcare supply chain expert, discusses how predictive analytics, AI, and automation are streamlining US pharmaceutical manufacturing—cutting overhead, boosting efficiency, and enhancing safety.

The CDMO will be cutting 350 jobs at its Baltimore gene therapy site after a major client’s demand shift, less than a year after Novo Holdings’ $16.5 billion acquisition.

The EQUIP-A-Pharma program will combine Battelle’s synthesis platform and Aprecia’s 3D printing technology to produce APIs and finished drugs at the same site, aiming to strengthen US pharma supply resilience and support essential medicines.

In the eighth part of this roundtable discussion, supply chain experts emphasize that effective manufacturing strategies depend on product type, market location, and regulatory complexity, requiring a careful balance between outsourcing, internal production, regional distribution, and patient-centric priorities.

In the second part of his Pharma Commerce video interview, Dave Malenfant, a healthcare supply chain expert, outlines how the impact of a steep pharmaceutical import tariff varies across raw materials, components, and finished products, along with why such a policy could incentivize companies to shift production to the US.

The directive calls for building a six-month Strategic Active Pharmaceutical Ingredients Reserve, updating the essential medicines list, and prioritizing US-made APIs.

Despite the ongoing turmoil over tariffs, medicine costs, and FDA policy, US wholesalers are performing well.

The new North Chicago facility, slated to open in 2027, will boost domestic production of key drug ingredients for immunology, neuroscience, and oncology therapies, reinforcing US pharmaceutical capacity amid industry reshoring and tariff concerns.

The CDMO’s new services at its Hopewell, NJ facility delivers scalable, phase-appropriate production, in-house quality control, and domestic sourcing to help gene therapy developers reduce complexity, speed timelines, and ensure regulatory compliance.

A new two-phase initiative aims to streamline facility approvals, reduce reliance on foreign pharmaceutical production, and bolster domestic supply chain resilience amid rising tariffs and reshoring investments.

Meanwhile, drugmakers ramp up US manufacturing investments to navigate policy shifts and protect supply chain resilience, as the Trump administration enacted tariff rates between 10% to 50% on various trading partners early this morning.

With 14 new lawsuits filed and 132 total complaints across 40 states, Novo Nordisk is intensifying efforts to protect patients from unapproved compounded semaglutide products by targeting pharmacies, telehealth providers, and deceptive marketing practices that compromise safety, mislead consumers, and violate FDA regulations.

The Spain-based CDMO strengthens its North American presence and capabilities through its purchase, while also acquiring a new rare disease treatment from Sanofi one month prior.

The letters demand US drug prices match or undercut global lows, triggering a 60-day compliance timeline, and prompting strategic responses from players in the space, including Celltrion.

Regeneron has received a second complete response letter from the FDA for odronextamab and anticipates delays for Eylea HD due to inspection findings at a Catalent manufacturing site, despite continued strong revenue growth and pipeline momentum.

The new deal imposes 15% tariffs on most EU exports, including pharmaceuticals.