What Is Pharmaceutical Serialization and Why Is It Critical Today?

Overview: Pharmaceutical serialization assigns a unique identifier to every unit of medicine, creating visibility and accountability across the supply chain. With regulations such as the DSCSA now being enforced, serialization has become a safeguard against counterfeiting, diversion, and data gaps. Companies that manage it well gain faster recall capability, stronger partner confidence, and greater protection for patients and brands.

The Rising Pressure of Drug Serialization

Across the pharmaceutical supply chain, serialization has moved from being treated as a regulatory checkbox to a business necessity. Enforcement of the Drug Supply Chain Security Act (DSCSA) in the United States and equivalent mandates worldwide are reshaping daily operations for manufacturers, CMOs, and distributors.

The impact is felt at every step. Delays when packaging lines stumble, distributors questioning data integrity, and rising pressure to protect medicines from counterfeiting and diversion. The same requirements that create compliance challenges also create opportunities. Companies with strong serialization programs see faster recall execution, greater supply chain visibility, and stronger protection for patients and brands.

This article examines the drivers making serialization urgent, the implementation challenges companies face, and the broader business benefits of serialization in the pharmaceutical industry.

What Is Pharmaceutical Serialization?

Pharmaceutical serialization assigns a unique identifier to every saleable unit of prescription medicine and maintains a record of that identifier throughout the supply chain. Each code links to product data such as lot number, expiration date, and manufacturing details. Aggregation at the case and pallet levels extends traceability from packaging lines to the point of dispensing.

Serialization is not the same as broader track-and-trace programs. Track-and-trace monitors product movement, while serialization establishes the identity that makes tracking possible. Both are necessary for regulatory and security requirements.

Key Elements of Pharmaceutical Serialization

• Unique identifiers: one-of-a-kind codes applied to each unit.
• Aggregation: linking units to cases and pallets for efficient handling.
• Data exchange standards: frameworks such as GS1 and EPCIS.
• Verification processes: checks by manufacturers, wholesalers, and dispensers.

Why Compliance and Product Security Are Under Greater Scrutiny

The regulatory phase-in period is over. The DSCSA in the United States now requires interoperable, electronic tracing at the package level, while the EU’s FMD and regulations in Asia, the Middle East, and Latin America impose similar expectations. For manufacturers and CMOs, the tolerance for partial compliance has narrowed.

At the same time, threats to the integrity of the drug supply chain are increasing. Counterfeit medicines remain a multibillion-dollar problem worldwide, and product diversion continues to undermine both safety and profitability. Serialization provides a mechanism to detect and prevent these activities by linking each unit to verifiable data that trading partners can trust.

Key reasons serialization is a top priority in 2025:

• Enforcement deadlines: Regulators are now focused on compliance, not extensions.
• Counterfeit risk: Unique identifiers and verification help safeguard patients.
• Diversion and theft: Serialized packaging makes it harder for products to be illegally redirected.
• Data integrity: Electronic exchange builds confidence among wholesalers, distributors, and dispensers.
• Transparency: Serialization delivers visibility that supports recalls and strengthens brand trust.

Serialization has become both a regulatory requirement and a safeguard for the pharmaceutical supply chain.

Challenges Manufacturers and CMOs Face With Serialization Programs

Even companies that have been preparing for years encounter obstacles when rolling out or scaling pharmaceutical serialization. The technical demands touch every layer of the supply chain, from packaging lines to enterprise data systems, and success depends on consistent performance across them all.

Common challenges include:

• Packaging line integration: Printers, vision systems, and verification stations must apply and confirm codes without slowing throughput. Any downtime can quickly lead to costly delays.
• Data management: Serialization generates massive volumes of data that must be structured, stored, and shared according to standards such as EPCIS. Synchronizing information across contract manufacturers, wholesalers, and dispensers requires precision.
• Interoperability: Different partners may use different systems or vendors. Without a reliable gateway, exchanging compliant data becomes a barrier.
• Scalability: What works in a pilot run may falter when expanded to global production levels or multiple packaging formats.
• Cost and resource allocation: Serialization requires ongoing investment in equipment, software, maintenance, and trained personnel.

For many organizations, the challenge lies less in applying codes to packages and more in ensuring the entire network of partners can trust, verify, and act on the data in real time.

Beyond Regulatory Compliance: Business Value of Serialization

Pharmaceutical serialization is often viewed through the lens of regulation, but its advantages extend well beyond avoiding penalties. Companies that build effective serialization programs gain tools to respond faster, operate more efficiently, and strengthen their relationship with both partners and patients.

Business benefits include:

• Recall execution: Serialization allows companies to isolate affected products quickly and remove them from distribution with greater precision.
• Brand protection: Unit-level identifiers and verification processes make it harder for counterfeit goods to reach the market, safeguarding both patients and company reputation.
• Supply chain visibility: Serialized data supports inventory management, demand forecasting, and more efficient distribution.
• Customer trust: Trading partners and patients gain confidence when authenticity can be verified at any point in the supply chain.
• Consumer engagement: Advanced security labels and mobile verification create new ways to interact with patients and healthcare providers.

Rather than being limited to a compliance exercise, serialization has become a way to improve resilience, efficiency, and trust across the pharmaceutical value chain.

How Covectra Supports Traceability and Authentication

Serialization is complex because it touches every stage of the pharmaceutical supply chain. Printing codes on packages is only one step; the real challenge lies in connecting packaging equipment, enterprise systems, and trading partners while maintaining accuracy at scale. Covectra addresses this through AuthentiTrack Serialization Software, which can be implemented as a complete system or as individual modules tailored to specific needs.

Core offerings include:

• AuthentiTrack Enterprise: provides a complete serialization operation at the plant level for companies with multiple lines within their facility.
• AuthentiTrack Prime: affordable serialization solution for a semi-automatic or manual, low-volume packaging operation facilities.
• AuthentiTrack Cloud: serialization cloud solution that provides serial number provisioning, and event history repository.
• AuthentiTrack Gateway: serialization communication between the packaging line systems and external parties to handle the complexity of messaging format requirements between different EPCIS providers.
• Engineering and consulting services: support for packaging line integration, data management, and system validation, helping manufacturers and CMOs maintain uptime and compliance as regulations evolve.

By combining serialization, traceability, and product authentication in one ecosystem, Covectra enables pharmaceutical companies to secure products and strengthen confidence across the supply chain.

Questions to Ask When Choosing a Serialization Partner

Regulatory compliance is only one part of evaluating a serialization partner.

Manufacturers and CMOs also need systems that support growth, adapt to evolving requirements, and integrate with existing operations.

Questions to consider include:

• Does the system ensure DSCSA and GS1/EPCIS compliance?
• Can it scale with packaging volumes and formats?
• How is serialization data managed and secured?
• What level of support and maintenance is provided?
• What is the total cost of ownership?

Evaluating solutions against these questions helps companies align their investment with compliance needs and operational goals.

FAQ on Pharmaceutical Serialization

How does pharmaceutical serialization differ from track-and-trace?

Serialization assigns a unique identifier to each saleable unit of medicine. Track-and-trace refers to monitoring the movement of those serialized products through the supply chain. Both are necessary for full compliance with DSCSA and other global regulations.

Is serialization required in every market?

Most major pharmaceutical markets, including the U.S., Europe, India, China, and parts of the Middle East, have serialization mandates. Requirements vary, but regulators are broadly aligned on the need for unit-level identifiers and electronic data exchange.

What happens if companies miss DSCSA compliance deadlines?

Failure to comply can result in shipment holds, fines, or removal of product from distribution. Noncompliance may also damage relationships with wholesalers, distributors, and pharmacies who require serialized data to accept shipments.

How does serialization protect against counterfeit medicines?

Unique identifiers, coupled with verification processes, promote counterfeit prevention, making it difficult for counterfeit or diverted products to enter legitimate supply chains. Additional layers such as security labels further strengthen product authentication.

Strengthening the Pharmaceutical Supply Chain Through Serialization

Serialization has become a defining requirement for the pharmaceutical industry. Regulatory enforcement is now in effect, counterfeit threats continue to evolve, and trading partners expect accurate, verifiable data at every stage of distribution. Companies that invest in robust serialization programs are not only meeting compliance deadlines but also improving recall readiness, supply chain visibility, and brand protection.

Covectra supports these goals with solutions that bring together serialization, traceability, and product authentication in one integrated approach. Manufacturers and CMOs can reduce risk, safeguard patients, and operate with greater confidence across global markets.

Contact Covectra Today

Take the next step toward compliance and supply chain security — connect with Covectra to evaluate your serialization program.