Manufacturing & Packaging

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.

This episode of Pharma Pulse discusses a new executive order to build a domestic API stockpile, Eli Lilly’s 170% price increase for Mounjaro in the UK, and long-term research confirming the safety of aluminum in childhood vaccines.

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.

This episode of Pharma Pulse explores AbbVie’s $195 million investment to expand US API production, new survey results showing mail-order and supermarket pharmacies outpacing traditional chains in customer satisfaction, and rising affordability pressures as insurers restrict GLP-1 coverage.

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.

In the first part of his Pharma Commerce video interview, Dave Malenfant, a healthcare supply chain expert, explains how steep pharmaceutical import tariffs might affect costs at different points in the supply chain, why component pricing poses a bigger risk than active ingredients, and how insurers, distributors, and manufacturers may negotiate to shield patients from price increases.

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.

These innovations are revolutionizing pharmaceutical packaging by enhancing drug safety, combating counterfeiting, ensuring regulatory compliance, and improving patient adherence across the supply chain.

Cellular Origins, CGT Catapult, and Resolution Therapeutics partner up to design a fully automated, scalable CGT manufacturing solution, with the goal of accelerating patient access to cell therapies.

The company joins a wave of global pharma companies reshoring operations to strengthen the US supply chain and meet patient needs through domestic innovation and capacity.

In the second part of this roundtable discussion, a panel of key opinion leaders dive into the key risk factors impacting the pharma manufacturing space, and how the industry should aim to address them.

The collaborative research initiative will be focused on advancing approaches to enhance the therapeutic efficacy of regulatory T cells and tumor-infiltrating lymphocytes.

In the second part of his Pharma Commerce video interview, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, explains how recent shifts in FDA leadership, funding constraints, and evolving CMC standards have each played a role in this process.

In the first part of his Pharma Commerce video interview, Mark Sawicki, PhD, Cryoport Systems’ president and CEO, discusses both the successes and challenges in commercializing cell and gene therapies.

The new system meets the increasing demand for faster, more precise processes that enhance quality while boosting efficiency in the pharma manufacturing industry.