Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines Episode 28

Ask the Expert

Outsourcing Partnerships Fuel Global Biopharma Discovery and Scale-Up

Drug Digest February 2026 

How It Helps Avoid Facility and Equipment Problems

A “Plan, Prevent, Prove” Approach

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Ask the Expert: Investigating Patient Complaints About Combination Products

Welcome to the Ask the Expert video series. This series is an extension of the PharmTech 

Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

In this episode of Ask the Expert, Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, address the complexities of investigating patient complaints regarding pre-filled syringe (PFS) and combination products. Schniepp and Schmitt make it clear; for manufacturers who purchase commercial syringes for their drug products, the marketing authorization holder (MAH) remains ultimately responsible for product performance, regardless of their level of control over the component manufacturer.

Investigating these types of events comes with complications, such as the lack of physical evidence (eg, returned devices, photos, or videos) when products are self-administered at home. While the rise of home-administered medications like GLP-1s has tempted some firms to cite “human error” as a root cause, manufacturers must ensure devices are “fit for purpose” across diverse populations, including the elderly and those with disabilities. If real-world evidence reveals a performance gap, it may indicate that initial usability testing may not have been sufficiently varied or robust.

There are also limitations with traditional corrective and preventive actions and recall procedures for these types of complaints. Identifying specific patients for recalls is often impossible once a product is dispensed, and privacy laws, such as HIPAA in the United States, can hinder a manufacturer’s ability to gather critical patient-specific investigation data. Furthermore, responding to patient complaints requires different language than communicating with healthcare professionals to ensure the investigation's logic is understood.

To manage these risks, the experts stress the importance of highly granular quality agreements. These agreements must move beyond simple checklists to explicitly define which party takes the lead in investigations, preventing a “blame culture” between drug manufacturers and component suppliers. Finally, companies must regularly revisit complaint procedures to adapt to evolving business environments, such as direct-to-patient shipping, to ensure they can effectively defend their “effectiveness checks” during regulatory inspections.

Watch the video to find out how Sue and Siegfried answer the question, “My company got a complaint from a patient that their prefilled syringe failed to inject. We make the drug product and purchase the syringe. How do we investigate a problem with the commercial syringe component that we used?”

Susan J. Schniepp is distinguished fellow at Nelson Labs and a member of 

Siegfried Schmitt, PhD, is vice president, Technical at Parexel and a member of 

Videos

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how companies can investigate patient complaints involving prefilled syringes and combination products.

Drug manufacturing process. Medical pills, capsules conveyor line at a high-tech pharmaceutical plant. Pharmacology production, medicine industry. Laboratory, factory, pharmacy. Healthcare, pharma 3D | Image Credit: ©Corona Borealis - stock.adobe.com

In the evolving landscape of pharmaceutical manufacturing, the industry is reaching a point where strategic facility design must balance immediate market demands with long-term operational sustainability. Current market drivers are influenced by the twin requirements of cost and speed to market, though these needs are becoming increasingly nuanced depending on the specific drug type and company profile.

Peter Makowenskyj, senior director of Design Consulting at G-CON, and Beata Sweryda-Krawiec, associate director at Boehringer-Ingelheim, took a look at the decisions being made by pharmaceutical companies when it comes to current good manufacturing practice (cGMP) facility design during a Quick Fire discussion, “

” at INTERPHEX on Tuesday, April 21, 2026.

 The event is being held in New York City from April 21-23, 2026.

How Do Engineering and Procedural Controls Conflict?

Tension exists in modern pharmaceutical facility design between engineering-based controls and procedural-based controls.Often, projects facing budget constraints look to “value engineer” designs by reducing engineering controls—such as physical segregation techniques for material and personnel flow—in favor of instituting stricter procedural controls. However, this creates a significant trade-off, as it shifts the burden of criticality onto the quality team and increases long-term operating costs compared to robust upfront engineering.

What About Lifecycle Cost and Material Selection?

Makowenskyj and Sweryda-Krawiecemphasized that the industry is moving away from traditional construction methodologies that relied on readily available materials not originally designed for pharmaceutical use. Instead of selecting the cheapest materials, designers should prioritize cost-effective materials that offer the best performance over the entire lifecycle of the facility. Choosing inferior materials can lead to compounding maintenance costs and higher operational expenses over time.

Operational Efficiency and Capacity Utilization

Operating costs remain a concern, particularly the fixed costs associated with maintaining 24/7 environmental conditions, such as air cycle rates and temperatures. The industry has seen a trend, especially within the advanced therapy medicinal products and contract development and manufacturing organization sectors, where many new facilities were built with low utilization rates due to small product pipelines. Maintaining high utilization rates is essential for facility viability, as low utilization can lead to industry consolidation.

What Roles Do Digitalization, Robotics, and Artificial Intelligence Play?

The future of pharmaceutical facilities is linked to digitalization, which serves as the foundation for leveraging data effectively. Key technological shifts include:

Automated filling lines and robotic systems are now handling everyday tasks, driving down the overall cost of facilities.

AI adoption is increasing, with an uptake rate now surpassing 20%. AI is being used for predictive analytics to understand component failure rates, allowing companies to reduce expensive redundancy while avoiding shutdowns.

Leveraging digital twins and cloud-based solutions allows facilities to “flex” their operations, such as decreasing air change rates when appropriate to reduce energy consumption while maintaining compliance.

Regulatory Harmonization and Agile Facilities

As these technologies advance, regulatory harmonization between global agencies remains a challenge. While many enabling technologies for agile and point-of-care manufacturing were discussed a decade ago, only now is the technology and regulatory support from agencies like the FDA catching up to make these independent, decentralized facilities a reality.

The panel suggested the industry shift from focusing solely on CapEx to a focus on the total cost of investment over time. By putting more money into the upfront design and choosing the right technological integrations, companies can ensure their facilities operate with maximum efficiency and lower total costs throughout their functional lifespan.

Makowenskyj P, Sweryda-Krawiec B. Quick Fire: “

https://www.interphex.com/en-us/education/education-schedule/session-details.4766.258095.quick-fire-drivers-for-future-cgmp-facilities.html

Articles

Pharmaceutical cGMP facility strategy is increasingly defined by optimizing speed-to-market and cost while avoiding downstream operational inefficiencies. Budget-driven “value engineering” that replaces engineering controls with procedural controls can shift criticality to Quality and inflate long-term OPEX. Material selection is moving toward lifecycle performance rather than lowest upfront price to limit maintenance escalation. Sustained viability depends on high capacity utilization, particularly in ATMP and CDMO builds. Digitalization, robotics, AI, and digital twins enable predictive maintenance, reduced redundancy, and energy-flexed operations amid evolving regulatory harmonization.

Peter Makowenskyj, senior director of Design Consulting at G-CON, and Beata Sweryda-Krawiec, associate director at Boehringer-Ingelheim, discussed trends influencing the design of pharmaceutical manufacturing facilities during a Quick Fire Learning Lab at INTERPHEX 2026.

The Future of CGMP Facilities

Fellow
Aseptic & Sterile Products
CRB Group

Sr. Fellow 
Aseptic and Sterile Products
CRB Group

At INTERPHEX 2026, Todd Vaughn and Christa Myers of CRB Group discuss rising automation in aseptic manufacturing and growing regulatory focus on sterility.

Robotics in the Aseptic Core: Rising Urgency, Rising Expectations

In part 1 of a multi-part video interview on day one at 

, CRB Fellows Todd Vaughn and Christa Myers discuss the expanding role of robotics and automation within aseptic and sterile pharmaceutical manufacturing, as well as what it means for operations and regulatory compliance.

Both experts note that robotics in the aseptic core is not a new phenomenon but that the pace and urgency have shifted considerably. As Myers explains, "This is not the first period of time that robotics have gone into the aseptic core, but we're seeing a lot more information about it right now, and regulatory is dramatically more interested in it now than they have been in the past." The driving force behind this regulatory interest is sterility assurance and, ultimately, patient safety, moving away from traditional fill lines for which personnel worked in close proximity to the product toward greater separation between operators and the final drug product.

Vaughn highlights that while the direction is clear, execution is complex. "It's not going to be straightforward right away, but it's a challenge I think the industry is ready to take on as a whole." Removing human operators from the process requires anticipating every possible failure scenario and engineering automated solutions to handle them, a significant upfront investment in both planning and cost.

Myers adds another layer of complexity: teams must now plan not just for expected interventions, but for unexpected ones, requiring deeper, earlier engagement in the design process. The industry's response has been a strong appetite for data, with manufacturers and design partners building robustness and data collection into facility and line designs from the outset.

AI-powered pharmaceutical and medical analysis concept with gloved lab hands working with chemical samples and glassware, digital data interface in clinic lab. | Image Credit:  ©TSViPhoto -stock.adobe.com


, which is being held in New York City from April 21-23, the use of artificial intelligence (AI) in pharmaceutical development and manufacturing was a popular topic. The Panel Discussion: “

Closing the AI Adoption Gap in Pharmaceutical Development and Manufacturing

 featured Shane Grosser, executive director, Pharmaceutical Analysis and Digital Technologies at Merck; Nicholas Guros, director, Upstream and CLD Digital and AI Transformation at AstraZeneca; Gorgi Pavlov, principal scientist at Johnson & Johnson (J&J); and Joshua Sperry, associate director, Automation at Regeneron. The panel was moderated by Kiefer Eaton, head of Pharma & Chemicals at Basetwo AI. The discussion centered on the practical application of AI, machine learning (ML), and digital twins to optimize process development and manufacturing while addressing the systemic challenges of data integrity and organizational culture.

What Are AI’s Advanced Applications in Process Development?

A primary focus of the discussion was the move toward hybrid modeling. The experts detailed the use of neural ordinary differential equations (neural ODEs), which combine machine learning with mechanistic understanding to predict bioreactor performance. This approach allows scientists to forecast day 12 titers with high accuracy as early as the beginning of a run by analyzing glucose profiles and environmental conditions.

The use of modeling to bridge gaps between experimental and theoretical work, specifically aiming to predict critical quality attribute (CQA) failures, was highlighted. For high-value products, where batch failure is not an option, these models serve as a tool to translate laboratory insights to commercial-scale manufacturing. At AstraZeneca, the focus includes using digital twins to reduce the volume of analytical assays required, thereby streamlining the development lifecycle.

What Is the Most Significant Barrier to AI Adoption?

Despite the promise of AI, the panel unanimously identified data foundations as the most significant barrier to progress. While advanced ML models exist, the lack of structured metadata and the prevalence of data silos—spanning PDFs, Excel files, and SharePoint—hinder scalability.

To combat this, the panelists proposed two distinct strategies:

Automated data structuring. Manual data structuring may create an undue burden on scientists. Intelligent controls and instruments can automatically generate machine-readable, structured data at the point of collection.

Unified namespaces: There is a need for digital shadows and a unified namespace across sites to eliminate data transients and transcription errors, ultimately aiming for a vendor-agnostic digital ecosystem.

The transition to AI-driven manufacturing requires a cultural shift, as well as a technical one. The panel discussed the higher bar of trust applied to AI systems compared to humans; while a human error might be overlooked, a single AI hallucination can trigger skepticism. Building trust requires the following:

Incremental validation. Starting with low-risk applications, such as clone selection, and proving statistical confidence before scaling up.

QA collaboration. Engaging quality assurance colleagues early through computer software assurance (CSA) frameworks to ensure that AI-driven, risk-based decisions meet regulatory standards.

The return on investment for these technologies extends beyond simple cost-cutting. Panelists highlighted that AI could lower the cognitive load on scientists by automating bookkeeping and data parsing, allowing them to focus on the high-level research they were trained for.

Furthermore, with a reported 20% year-over-year increase in data integrity observations across the industry, AI is increasingly viewed as a defensive necessity. By “hardening” data through automated pipelines and AI-driven scripts, companies can support increasingly complex pipelines with existing staff levels while maintaining rigorous compliance.

The path forward for the adoption of AI in pharma processes may involve moving away from manual data management toward integrated, automated systems that empower human expertise with predictive, machine-led insights.

 for more from INTERPHEX 2026 and other conferences.

Eaton K, Sperry J, Grosser S, Guros N, Pavlov G. Panel Discussion: Closing the AI Adoption Gap in Pharmaceutical Development and Manufacturing. INTERPHEX 2026. New York, NY. April 21, 2026. 

https://www.interphex.com/en-us/education/education-schedule/session-details.4766.258092.panel-discussion-closing-the-ai-adoption-gap-in-pharmaceutical-development-and-manufacturing.html

AI deployment in biopharma is shifting from exploratory analytics to hybrid, mechanistic-ML approaches such as neural ODEs and digital twins that can forecast bioreactor performance and anticipate CQA risk early in a run. The dominant constraint is not algorithm availability but data readiness—unstructured, siloed content and weak metadata limiting scale and transferability across sites. Progress depends on automating structured data capture at collection and establishing unified namespaces. Cultural adoption hinges on incremental validation and early QA partnership via CSA, with ROI framed as productivity, compliance defense, and workforce scalability.

Panelists at INTERPHEX 2026 talked about the move to hybrid modeling for process development and the barriers to the adoption of artificial intelligence in pharmaceutical manufacturing.

Addressing the AI Adoption Gap

Drug manufacturing process. Conveyor with medical ampoules line at a modern pharmaceutical plant. Pharmacology production, medicine industry from laboratory 2 factory, pharmacy. Healthcare, pharma 3D | Image Credit: ©Corona Borealis -stock.adobe.com

The International Society of Pharmaceutical Engineering (ISPE) has announced the 2026 ISPE Facility of the Year (FOYA) Category Winners at the 2026 ISPE Europe Annual Conference. The FOYA program recognizes excellence in innovation, operations, supply chain, Pharma 4.0, and social impact by taking into account the way facilities are designed, delivered, and operated.

 The ISPE FOYA program was established in 2005 to recognized state-of-the-art facilities that incorporate innovative technologies.

Companies were noticed for their modular and digital manufacturing approaches, sustainability-focused infrastructure, accelerated project execution, and integrated quality and supply strategies. The way the companies used engineering solutions, advanced technologies, and cross-functional collaboration to address regulatory, operational, and societal requirements was also taken into consideration when deciding on winners of each category.

"This year's FOYA Category Winners illustrate how pharmaceutical manufacturing is evolving to meet some of the industry's most complex challenges," said Parag Sane, AVP, Global Capital Projects, Amgen, and FOYA Judging Chair, in a press release.

 "These projects reflect bold thinking, disciplined execution, and a strong commitment to agility, sustainability, and patient-focused outcomes. Together, they set new benchmarks for excellence in regulated manufacturing and exemplify the purpose of the FOYA program—to recognize engineering achievements that advance our industry and benefit patients worldwide."

Who Are the Winners of the ISPE Facility of the Year Awards?

The following are the winners of the 2026 FOYA Awards:

2026 Category Winner – Innovation – Novel Technology


Project Name: Shenzhen Hepalink Pingshan New Pre-filled Syringe Manufacturing Facility
Location: Shenzhen, China

2026 Category Winner – Innovation – Facility of the Future


Project Name: Modulus
Location: Neuville-sur-Saône, France and Tuas, Singapore

2026 Category Winner – Operations – Operational Excellence


Project Name: SOLIDA-1
Location: Leverkusen, Germany

2026 Category Winner – Operations – Project Execution


Project Name: Lilly Concord
Location: Concord, North Carolina, USA


Project Name: An integrated state-of-the-art site for antibody-drug conjugates, drug substance, and drug product, from investigational new drug to commercial supply
Location: Latina, Italy

2026 Category Winner – Social Impact – Unmet Medical Needs


Project Name: Commercial Cell Therapy Facility
Location: Rockville, Maryland, USA

2026 Category Winner – Social Impact – Sustainability Efforts


Project Name: AHEAD (Advanced Heat Pump Demonstrator)
Location: Vienna, Austria

2026 Category Winner – Honorable Mention


Project Name: FJ3 Project
Location: Fujieda, Shizuoka, Japan


Project Name: Galaxy Project
Location: Holly Springs, North Carolina, USA

ISPE will formally recognize the winners and announce the overall winner at the 2026 FOYA Banquet and Awards Celebration, which will take place during the 

, Ranjit Deshmukh, founder of BiologixCMC, spoke about the importance of contract manufacturers staying on top of industry trends when it comes to facility design. According to Deshmukh, a facility must remain adaptive to future requirements, and he advises contractors to stay abreast of industry trends and regulatory shifts, as well as surveying stakeholders to anticipate needs.

Visit PharmTech.com to watch the full interview.

ISPE announces 2026 Facility of the Year Awards (FOYA) Category Winners. Press Release. April 21, 2026. 

Deshmukh R. Facility design for optimized contract manufacturing. 

https://www.pharmtech.com/view/facility-design-for-optimized-contract-manufacturing

ISPE named the 2026 Facility of the Year Awards category winners, emphasizing excellence across innovation, operations, supply chain performance, Pharma 4.0 enablement, and social impact. Recognized projects demonstrate modular and digital manufacturing, sustainability-forward utilities, accelerated delivery models, and integrated quality and supply strategies within regulated environments. Winners span prefilled syringe manufacturing, “facility of the future” platforms, solid-dose and Pharma 4.0 transformations, end-to-end ADC capability, and commercial cell therapy scale-up. Adaptive facility design aligned to evolving regulatory and stakeholder requirements remains central.

Winners in 8 categories were announced at ISPE’s Europe Annual Conference.

ISPE Awards Winners of Facility of the Year

Interview with Noritsugu Fujima of Teruno

A New CDMO Strategy

The CDMO industry is undergoing a fundamental transformation, driven by the growing complexity of new drug modalities including biologics, DNA medicines, RNA medicines, and cell and gene therapies. Noritsugu Fujita, President, Pharmaceutical Solutions Division at Terumo, highlights the need for more resilient, reliable supply chains that move beyond fragmented, transactional relationships. One approach gaining traction is the fully integrated CDMO model, which consolidates the entire parenteral drug development journey—from formulation and sterile fill-finish to device assembly, labeling, and final packaging—under a single partner. Fujita emphasizes aligning drug, device, and patient interaction considerations early in development, with the goal of proactively addressing compatibility challenges before they affect timelines or regulatory submissions. Aside from mitigating these challenges, consolidation with a single partner can help customers reduce their carbon footprint and simplify their supply chains.

The CDMO landscape is shifting toward long-term strategic partnerships as drug modalities grow more complex and supply chain pressures mount. Noritsugu Fujita, President, Pharmaceutical Solutions Division at Terumo, explains how an integrated, single-source model for parenteral drug development aims to streamline the path to a patient-ready product.

The Trends Shaping a CDMO Partnership

testing drugs and vaccine on mice | Image Credit: ©filin174 -stock.adobe.com

On April 20, 2026, FDA announced it has reached key first-year goals that were set for the implementation of the April 2025 Roadmap to Reducing Animal Testing in Preclinical Safety Studies,

 an effort by the agency to modernize drug development and reduce testing on animals.

 To detail its efforts, the agency released a report, 

Reducing Animal Testing in Nonclinical Studies Year One Progress and the Path Forward April 2026

 updating its progress in minimizing animal use in drug development.

In the past year, FDA has released a draft guidance 

on the reduction or elimination of nonhuman primate testing in monoclonal antibody development

and updated a guidance on transitioning away from horseshoe crab-derived endotoxin testing. A draft guidance expanding the use of weight-of-evidence approaches to support the use of 

 enabling the use of in vitro assays, computational toxicology, and other human-relevant models to generate evidence across a wider array of safety endpoints.

The agency has also worked on accepting safety data from sources other than animal testing in drug approvals, such as data from other countries where the drug is already being used by humans. It also qualified an artificial intelligence tool for leveraging in silico models in regulatory decision-making. And a searchable database was launched that clarifies which alternative methods can be used.

What Are the Benefits of Limiting Animal Use?

According to FDA, animals are not a good model for how drugs perform in the human body. Most drugs (90%) that clear animal studies do not get FDA approval because of safety or efficacy problems in humans. The agency believes NAMs, such as in vitro systems, computational modeling, and human-derived platforms, reflect human biology better and improve the prediction of drug effects.

In similar efforts, the US Pharmacopeia (USP) released a chapter in 2024 on endotoxin testing using non-animal derived reagents.

, Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, at Parexel, explained how the USP chapter may impact industry.

“Twenty years ago, the predominant test procedure for determining endotoxin level, or pyrogen level, as we called it, was the rabbit test. And we used to actually inject rabbits, which was a very subjective because you'd measure their temperature,” said Schniepp. “And then we evolved to using the limulus amoebocyte lysate or LAL test, and there was the chromogenic [test] but they were all predicated off the horseshoe crab. So now we're moving forward to reagents for this test, which is critical to the release of sterile injectables that does not involve animals. So absolutely, we should consider this.”

“One year ago, we issued an ambitious roadmap to eliminate unnecessary animal testing and replace animal testing with more precise ways of predicting drug safety in humans,” said FDA Commissioner Marty Makary, M.D., M.P.H., in a press release.

 “In addition to ushering in more scientifically accurate way to test drugs before they are used in humans, the agency has made great strides to reduce research and development costs, which will lower drug prices for everyday Americans.”

The agency has created a permanent pathway for qualifying innovative drug development tools, cross-center scientific reviews, and a formal partnership with the National Institutes of Health to shift toward human-relevant science as the default approach to drug evaluation. FDA hopes this direction will improve drug safety, accelerate drug development, and reduce costs, all while reduce the use of animals.

FDA. Roadmap to Reducing Animal Testing in Preclinical Safety Studies. FDA.gov. April 2025. Accessed April 21, 2026. 

https://www.fda.gov/media/186092/download?attachment

FDA. FDA achieves year 1 goals in reducing animal testing in drug development. Press release. April 20, 2026. Accessed April 21, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-achieves-year-1-goals-reducing-animal-testing-drug-development

Reducing Animal Testing in Nonclinical Studies Year One Progress and the Path Forward April 2026. 

https://www.fda.gov/media/191986/download?attachment

FDA. FDA releases draft guidance on reducing testing on non-human primates for monoclonal antibodies. Press release. December 2, 2025. Accessed April 21, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-releases-draft-guidance-reducing-testing-non-human-primates-monoclonal-antibodies

FDA. General Considerations for the Use of New Approach Methodologies in Drug Development Guidance for Industry, Draft Guidance. March 2026. Accessed April 21, 2026. 

https://www.fda.gov/media/191589/download

Chapter for endotoxin testing using non-animal derived reagents published for early adoption

Thomas F, Haigney S. Non-animal-derived reagents for endotoxin testing. 

. November 21, 2024. Accessed April 21, 2026. 

https://www.pharmtech.com/view/non-animal-derived-reagents-for-endotoxin-testing

FDA reported meeting first-year milestones under its April 2025 roadmap to reduce animal testing in preclinical safety studies, emphasizing a shift toward human-relevant new approach methodologies (NAMs). Actions included draft guidance to reduce or eliminate nonhuman primate studies for monoclonal antibodies, guidance updates supporting non–horseshoe crab endotoxin assays, and a new weight-of-evidence framework to broaden NAM applicability across safety endpoints. FDA also advanced acceptance of non-animal safety data, qualified an AI tool for in silico evidence, and launched a searchable alternatives database.

The agency is celebrating the achievement of key first year goals in implementing the Roadmap to Reducing Animal Testing in Preclinical Safety Studies.

FDA Reaches Key Goals for Reduction of Animal Testing in Drug Development

Senior Content Associate For Pharmaceutical Commerce

The US Customs and Border Protection (CBP) launched its new tariff refund portal on April 20, 2026.

 The portal provides a way for pharmaceutical importers to reclaim funds following a February Supreme Court rebuke of executive tariff authority, which declared certain tariffs unconstitutional.¹ For pharmaceutical companies navigating the 

 during the past year, the CBP action is the beginning of a repayment effort.

Why Are Companies Able to Receive Tariff Reimbursements?

In February, the U.S. Supreme Court issued a 6-3 opinion, ruling that the executive branch lacked the authority to use the 1977 International Emergency Economic Powers Act (IEEPA) to impose tariffs applied across a broad range of U.S. trading partners.²

The Court dismissed the administration's argument that the US trade deficit constituted a “national emergency” justifying the use of IEEPA, which authorizes the president to regulate commerce after a national emergency is declared. While previous presidents have used this law to place sanctions on certain countries, President Trump was the first to use it to justify tariffs.² This ruling invalidated a barrage of “reciprocal” tariffs, some as high as 50% for some countries, and a baseline 10% tariff that had been applied to other countries.² Tariffs imposed under other legal authorities were unaffected by the ruling.

The Supreme Court’s 6-3 decision directly impacts the pharmaceutical sector by invalidating IEEPA tariffs that squeezed margins on imported goods and ingredients.

Major US trade partners that were impacted by these tariffs included the European Union, South Korea, and Japan, which exported pharmaceuticals to the U.S. alongside other goods. India, whose major imports to the U.S. include pharmaceuticals, clothing, and textiles, also faced heightened tariffs during the past year.² According to CBP, more than 330,000 importers paid a total of $166 billion because of those tariffs.¹

For pharma importers, the ruling clarifies that the executive branch cannot unilaterally use IEEPA to regulate trade through tariffs. While some tariffs justified under other laws may remain, those specific duties collected under the IEEPA "emergency" umbrella are now eligible for return.

How Can Companies Receive Tariff Reimbursements?

To apply for reimbursements, companies have to register for the CBP’s electronic payment system and submit declarations that list products they imported. According to CBP, if a claim is approved, it will take 60-90 days for a refund to be issued.¹

The process requires strict adherence to CBP’s reporting standards. According to the agency, importers must ensure all digital declarations are precise, as any discrepancies in the listed products or the duties previously paid could delay the 60-90 day refund timeline. Because the total amount of duties to be returned is so high, reaching more than $166 billion across all sectors, companies should begin the electronic filing process immediately.

Anderson M. Trump administration to launch portal for tariff refunds following court ruling. 

. April 20, 2026. Accessed April 20, 2026. 

https://apnews.com/article/tariff-refund-trump-customs-08861f153801156d213c30c4e2f6a683

Grantham-Philips W. Supreme Court rules Trump’s use of emergency powers for global tariffs is unconstitutional. 

. February 20, 2026. Accessed April 20, 2026. 

https://apnews.com/article/trump-ieepa-tariffs-supreme-court-12487645072a1e1a387db60081509f3c

US Customs and Border Protection opened a tariff refund portal on April 20, 2026, enabling importers—including pharmaceutical companies—to recoup duties paid under tariffs invalidated by a February Supreme Court decision. In a 6–3 ruling, the Court held IEEPA did not authorize broad, partner-wide tariffs premised on the trade deficit as a “national emergency,” nullifying reciprocal levies and a baseline 10% tariff. Pharma importers facing compressed margins may now seek refunds via CBP’s electronic system, with payment expected within 60–90 days if filings are accurate.

Tariff reimbursements may be requested through the US Customs and Border Protection’s online portal.

How Can Pharma Importers Recoup Trump Tariff Payments?

Drug shortages are rising. Learn what's breaking the pharmaceutical supply chain, and what industry leaders are doing to fix it.

Drug Shortages Explained: Inside the Broken Supply Chain

The pharmaceutical supply chain is under unprecedented strain. Between 2018 and 2023, 258 unique active ingredients entered national shortages in the US, representing nearly 2,000 individual drug products. According to USP's 2025 Annual Drug Shortage Report, 89% of drug shortages in 2024 carried over from the previous year, with more than 40 lifesaving drugs in shortage for over three years. The consequences are tangible: delayed care, increased medication errors, and elevated patient mortality.

Four systemic drivers underlie these shortages, low pricing that discourages investment, geographic concentration of manufacturing (particularly in China and India), process complexity, and quality failures. Together, they create a fragile, domino-like system with little margin for disruption. The COVID-19 pandemic didn't create these vulnerabilities, but it made their consequences impossible to ignore.

Industry professionals describe a self-reinforcing cycle of caution. Mike Stenberg, Vice President, Business Development, LGM Pharma, explained "When you're pessimistic about your growth potential and you're worried about the supply chain and face an ever-increasing pressure on decreasing prices, your natural reaction in the industry is to slow down, be more cautious, invest less. That becomes a self-fulfilling prophecy."

In response, companies are rethinking sourcing strategies, vetting suppliers deeper down the chain, building safety stock, and pursuing geographic diversification. Reshoring, however, is costly: U.S. manufacturing runs 30 to 50 percent higher than in China, India, or Mexico. Policy is also catching up. Europe's newly published Critical Medicines Act encourages local production and resilient infrastructure. In the U.S., USP's Medicine Supply Map now tracks upstream supply chains for all approved medicines. Tony Lakavage, executive vice president and head of Global External Affairs, USP explained, "There are levers that we can use to make the supply chain stronger, more advanced manufacturing technology, near-shoring product development, and diversifying more broadly."



Pharmaceutical supply chain resilience: lessons from the pandemic. DrugPatentWatch. Published February 24, 2026. Accessed March 20, 2026. 

https://www.drugpatentwatch.com/blog/pharmaceutical-supply-chain-resilience-lessons-from-the-pandemic/

McGeeney JD, McAden E, Sertkaya A. Analysis of Drug Shortages, 2018-2023. Data Brief. Prepared by Eastern Research Group, Inc. for the Office of the Assistant Secretary for Planning and Evaluation (ASPE), U.S. Department of Health and Human Services (HHS); January 8, 2025. Accessed March 20, 2026. 

https://www.ncbi.nlm.nih.gov/books/NBK611681/

​The generic injectables market in USA: a critical pillar of healthcare facing growing strain. GRG Health. Published September 9, 2025. Accessed March 20, 2026. 

https://www.grgonline.com/post/the-generic-injectables-market-in-usa-a-critical-pillar-of-healthcare-facing-growing-strain

Ranjit Deshmukh is Principal at BiologixCMC.

Facility Design for Optimized Contract Manufacturing

Ranjit Deshmukh, who has 25 years of experience at firms such as Pfizer and AstraZeneca, spoke with 

 ahead of INTERPHEX 2026 to provide his insights into strategic facility design for contract development and manufacturing organizations (CDMOs). As the founder of BiologixCMC, Deshmukh emphasizes that CDMOs must design facilities with a long-term horizon, ensuring that chosen technologies remain viable and primary for at least 5-10 years.

Modern CDMOs must balance technological viability with high flexibility to meet the needs of diverse clients. Deshmukh highlights that the most efficient organizations focus on maximizing facility utilization through quick turnarounds . This is achieved by implementing standardized processes and utilizing similar, swappable equipment trains. While standardization is key, the facility’s operating model must remain adaptable enough to handle the unique nuances of various client processes. Ultimately, optimal performance is the result of strategic facility design, appropriate equipment choice, and refined operating strategies.

To adapt to future requirements, Deshmukh advises CDMOs to maintain a constant “pulse” on industry trends, regulatory shifts, and quality standards. This involves proactive engagement with leading clients, industry experts, and facility vendors during the early design phases. By probing and surveying these stakeholders, CDMOs can better landscape their technology decisions and effectively hedge their investments against future industry changes.

Deshmukh will be participating in the Quick Fire session, “

Facility Design Optimization for CMO and 503B Manufacturing

, which is being held in New York City from April 21–23.

Ranjit Deshmukh, Principal, BiologixCMC, discusses how contract manufacturers can optimize their processes and plan for the future by optimizing facility design. 

Featured Content

Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Behind the Headlines Episode 28

Ask the Expert

Drug Digest February 2026

A “Plan, Prevent, Prove” Approach