ANI Pharmaceuticals – Case Study
Client Overview
ANI Pharmaceuticals is a specialty pharmaceutical company focused on developing, manufacturing, and delivering high-quality branded and generic prescription products. As ANI continues to grow through acquisitions and expanding distribution networks, maintaining serialization accuracy and DSCSA compliance across partners is critical to keeping product moving to patients.
The Challenge
ANI was preparing for a major transition, moving to a new third-party logistics provider while maintaining full DSCSA compliance and keeping shipments flowing.
This wasn’t a simple system change. It involved coordinating with more than 100 trading partners, over 10 CMOs, and a high shipment volume of over one million serialized units per month.
At the same time, ANI had recently acquired Alimera Sciences, which brought additional complexity. Two SKUs and more than 10,000 serial numbers had to be migrated from a different serialization system and aligned with ANI’s existing processes.
During the 2024–2025 DSCSA stabilization period, industry performance scores were inconsistent due to high volumes of varied exceptions across the supply chain. Through VariTec’s engagement, operational performance improved significantly, reaching 90–100%.
From 2025–2026, performance has remained consistently near 100%, with the VariTec stabilization team proactively and reactively managing exceptions on a daily basis. This highlights the importance of maintaining a strong DSCSA and serialization SME team supported by the right tools and 24/7 engagement with downstream partners to quickly resolve EPCIS issues, maintain supply chain continuity, and ultimately prevent delays that could impact patients receiving their medications.
Another reality was the day-to-day operational workload. ANI receives a large volume of serialization-related emails and partner inquiries that require manual attention. During a 3PL transition, those requests naturally increase. VariTec worked closely with ANI and UPS throughout the process to help tune workflows and data exchange so that DSCSA issues could be reduced over time without disrupting operations.
VariTec’ s Approach
Building a Dedicated Serialization Operations Model
One of the first steps was putting the right structure in place. VariTec helped ANI stand up a dedicated serialization operations team responsible for handling DSCSA activity end to end, from inbound data to TPL and onto outbound data corrections and monitoring.
A project manager led the 3PL migration effort, but it quickly became clear that coordination across multiple internal teams would be essential. Additional support was deployed across ERP, EDI, serialization, and master data functions to keep everything aligned and moving on schedule.
VariTec also took full ownership of the UAT and testing coordination between ANI and UPS, covering both EDI and serialization data. The timeline was aggressive. ANI needed outbound go-live in early September, which left only about six weeks to test inbound processes and prepare for the transition of legacy inventory into production.
As expected, once the transition began, data issues surfaced. VariTec’s team worked directly with ANI and UPS to manually correct and resend serialized data where needed so that warehouses could receive inventory without delays. That hands-on support was critical to keeping product moving during the most sensitive phase of the transition. Varitec deployed extra resources for ANI as the demand was heavy during the Go-Live.
Working Alongside UPS to Improve Processes
Throughout the migration and stabilization period, VariTec worked closely with UPS to help refine data exchange and operational workflows. Like any large system transition, some issues improved quickly while others required longer-term adjustments. VariTec’ s role was to help ANI stay ahead of DSCSA risks while supporting ongoing collaboration with UPS to steadily improve performance and reduce disruptions.
This wasn’t just about fixing files. It was about building more reliable processes across partners.
Compliance, Documentation, and Ongoing Monitoring
Beyond the migration itself, VariTec helped ANI strengthen its compliance foundation.
- SOPs were updated and aligned with DSCSA requirements.
- Testing and validation processes were formalized.
- Regulatory updates were tracked to ensure ANI stayed ahead of changes.
- TraceLink expertise was leveraged to support trading partner connectivity and data accuracy.
This ensured ANI wasn’t just compliant during the migration but positioned for long-term stability.
Faster Response Times and Stronger Daily Operations
With a dedicated serialization team in place, ANI’s day to day operations improved significantly. Customer inquiries and partner issues are now managed much faster, with most inbound or outbound data issues resolved within 24 hours.
Partner onboarding also became more efficient. What used to take up to a month can now typically be completed in about one week, helping ANI scale more easily as new downstream partners are added. And most importantly, wholesaler scorecards stabilized, now consistently landing near 100%.Implementation Timeline
- Despite the complexity, the full migration was completed in roughly 10–12 weeks.
- This included:
- Coordinating SIT and UAT across ERP, EDI, serialization, and warehouse teams
- Managing legacy inventory transfer from the former 3PL
- Reconciling serialized data to physical shipments
- Correcting and resending files during early production
- ANI achieved its planned go-live milestone without interrupting customer shipments, which was the ultimate measure of success.
Results
- Successful transition to the new 3PL without disruption to product flow
- Wholesaler scorecards now consistently near 100%
- Support in place for 100+ trading partners and 1M+ shipments per month
- Most serialization issues now resolved within 24 hours.
- Partner onboarding reduced from one month to about one week.
- Improved coordination across ANI, UPS, and supply chain partners
- Greater visibility into serialized inventory and shipment data
Strategic Impact
Today, ANI is in a much stronger position operationally and from a compliance standpoint. The company is confident in its readiness for 2025 DSCSA enforcement and has a serialization support structure that can scale with the business.
The ANI DSCSA team is now widely recognized by partners as responsive and reliable, which builds trust across the supply chain.
ANI is also preparing for the next phase of its logistics strategy, including the transition of controlled substances to the new 3PL. With the experience gained during this migration, and VariTec’ s continued involvement, leadership has clear visibility into risks and how to mitigate them.
Why ANI Chose VariTec
ANI needed a partner willing to take real ownership - someone proactive, forward-thinking, and not limited to doing only what was asked.
VariTec was selected because of the accountability the team brings, the responsiveness partners experience, and the understanding that serialization performance directly impacts ANI’s reputation in the market.
The goal is simple but critical: resolve product exceptions quickly so distribution centers can receive product without delays and patients ultimately receive their medication on time. Every step in that chain matters
Client Testimonial
"VariTec’s expertise and dedicated support were critical in helping us seamlessly transition to a new TPL and achieve DSCSA compliance. Their proactive approach and industry knowledge made them an invaluable partner in our serialization journey"
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