Learn how Ritedose safeguards patients’ access to critical medications with responsive, high-quality pharmaceutical manufacturing.
Understanding Today’s Drug Shortage Landscape
Drug shortages are serious problems. In a shortage, patients and caregivers no longer have access to needed, even life-saving medicines, often for an extended period. And yet, drug shortages have been a part of the pharma landscape for decades. And it’s not improving.
Recent U.S. government actions, particularly tariffs and other actions curbing imports, have shown how vulnerable international pharma supply chains are. Branded pharmaceuticals (which have patent protection and other manufacturing advantages) are largely made in the United States (or other countries and regions) where those drugs are sold. Generic drugs are a different story, as this article in Science points out.
Generic medicines, which have lost patent protections and typically do not allow for the same margins as branded drugs, account for over 80% of all global prescriptions. But they only make up to 20-30% of global pharmaceutical market value. This means two things: critical medicines are more accessible to patients; however, their supply is more susceptible to disruptions.
For decades, this meant that generic manufacturing moved to a handful of countries (India and China, mainly) that could make these drugs at very high volumes and lower prices. By raising the costs of these imports (through tariffs and other barriers), firms that can’t operate under narrower earnings margins will cease manufacturing, adding to the risk of shortages.
Here, the government’s answer has been to reshore, to bring drug manufacturing back to this country. This is not an easy task. It takes investment, infrastructure and lead times measured in years, not weeks or months.
Examples of Ritedose Supporting Supply Stability
Responding to National Respiratory Medication Needs
This year, we addressed a nationwide shortage when we made the 0.5% (2.5 mg/0.5 mL) strength of generic albuterol sulfate inhalation solution. This dosage of albuterol has been on the FDA’s national shortage list since 2022.
How Ritedose Helps Address Drug Shortages
Responsive Manufacturing for Urgent Market Needs
At Ritedose, we provide manufacturing for both branded and generic drugs using our state-of-the-art CDMO (contract development and manufacturing organization) facility. Historically, we have produced respiratory and ophthalmic medications. Over time, we have increased our capacity for manufacturing and added additional expansions, including advanced Blow-Fill-Seal (BFS) capabilities and construction of new analytical laboratories. These investments continue to augment our manufacturing, making the total supply chain resiliency more effective.
Capacity and Expertise That Prevent Manufacturing Bottlenecks
This year, the U.S. Governmental Accountability Office (GAO) recommended collaboration and coordination among government regulators and manufacturers, and offered a series of solutions that could alleviate these shortages. This is their list of collaboration practices:
- Define common outcomes—identify crosscutting challenges and opportunities, and define long- and short-term outcomes
- Ensure accountability—find ways to monitor, assess, communicate and reward progress
- Bridge cultures—find ways to build trust and develop common language and terminology
- Clarify roles and responsibilities—identify all key participants and determine leadership and other tasks
- Resources and information—find ways to ensure collaboration and incorporate data management that provides reliable and visible data
- Develop written agreements—document collaboration plans and operations and make sure these are continually updated and implemented
The Future of Reliable Drug Manufacturing
Preventing and managing drug shortages is a collaborative effort among government, industry stakeholders, caregivers, patients and members of the public. Only then can we establish transparency and a clear path to alleviate unnecessary and dangerous shortages.
At Ritedose, we’re committed to ensuring access to much-needed, lifesaving medications. Our response to these complex issues is simple and unwavering: it’s every manufacturer’s responsibility to plan intentionally and safeguard supply. Patients should always be able to receive the medications they rely on, without delay and without doubt.
