Pharma Contract Packaging & Labelling Partners: Cost, MOQ & Regulatory Fit

Introduction

Worldwide compliance for pharmaceutical supply chains continues to grow and change, as a result the contract packaging industry has changed. This change has resulted in Contract Packaging and Labelling Partners' (CPLPs) evolving into more than just service vendors for buyers, but instead CPLPs are now playing an increasing role as regulatory risk holders.

To help buyers with the assessment of pharma packaging suppliers, this guide provides detailed information about the factors that impact the cost structure of packaging suppliers, including minimum order quantities, serialisation readiness, and capacity planning from a procurement perspective. (Also Read: Ultimate Global Pharma Buyer’s Guide: From RFQ to Regulatory Clearance)
 

Why Buyers Outsource Pharma Packaging & Labelling

Pharma companies who outsource their packaging operations have the ability to quickly scale their operations without the burden of heavy capital investments and gain access to local knowledge for labelling requirements specific to each country where they do business. Many times you will see this approach used when launching products in multiple countries or supplying contracted tenders, repackaging products for parallel importation or supporting short-term commercial production runs, where there is a lack of flexibility or capacity by in-house lines.

The regulatory and execution risks associated with outsourcing packaging have been moved to the packaging supplier, therefore, performing due diligence on a potential packaging supplier before committing, is critical for buyers to be able to mitigate these risks. (Also Read: Best CDMOs for Generic & Off-Patent Drug Manufacturing)
 

Contract Packaging & Labelling Costs

Costs for packaging vary widely due to complexity, volume and regulatory requirements/standards. Buyers should be aware that the price for packaging typically includes not only 'per-pack' pricing, but also the cost of set-up (line generation), materials, labour, QA oversight, and serialisation integration.

In most cases, simple secondary packaging and labelling will provide a cost advantage with higher volume runs, while packaging that has multiple language printed on the artwork and has tamper-evident features or market serialisation will significantly increase the per-unit cost. Other indirect costs (artwork revisions, line changeovers, and QA release timelines) will also need to be considered and may exceed initial estimates.
 

Aspects Related to Minimum Order Quantity (MOQ) that Buyers Need To Consider

Minimum order quantities (MOQs) are determined by factors such as the efficiency of the line(s), the production run's material procurement and the regulatory requirements for a batch/their associated documentation; these are national standards and not based solely on suppliers' preferences. Some packaging vendors may accept low MOQ's for clinical or pilot batches, but for commercial runs, a higher volume is typically required in order for the production run to be cost-effective.

When planning small production runs on a consistent basis, buyers will benefit from working with packaging suppliers that provide flexible lines, modular equipment and have experience with the short-run programmes, even if they charge slightly higher per-unit pricing. When buyers select suppliers solely based on MOQ, there is a potential risk of delayed production and increased costs due to a lack of understanding about how efficiently a line will be utilized.
 

Serialization Readiness — A Non-Negotiable in 2026

Serialization is now a baseline requirement across most regulated markets. Buyers must ensure that contract packaging partners can support country-specific serialization standards, manage serial number commissioning and aggregation, and integrate securely with the buyer’s ERP or track-and-trace systems.

Serialization failures can delay shipments, block market entry, or trigger regulatory scrutiny. Buyers should verify not only technical capability but also operational experience with live markets, not just test environments.
 

Artwork Management & Label Risk

Artwork errors remain one of the highest-risk areas in outsourced packaging. Incorrect language, dosage instructions, or regulatory symbols can result in batch rejection or recall.

Strong packaging partners use controlled artwork workflows, version tracking, multi-level QA review, and formal approval gates. Buyers should clearly define artwork ownership, revision authority, and turnaround timelines to avoid misalignment between commercial urgency and regulatory accuracy.
 

Regulatory Fit: More Than GMP Certification

A GMP certificate alone does not guarantee regulatory fit. Buyers should assess whether the packaging partner has market-specific experience, understands local labelling requirements, and maintains audit readiness for different authorities.

Packaging partners involved in parallel trade, re-labelling, or multi-country distribution must demonstrate exceptional documentation discipline, change-control management, and deviation handling.
 

Capacity Planning & Scalability

When selecting a partner, the buyer often does not take into consideration the capacity risk associated with the partner. In addition to understanding how many lines the partner has currently available, the buyer should be concerned with the partner's ability to scale up volume, add SKUs and/or accommodate a large number of urgent orders that are created by spikes in demand.

Transparency in capacity planning, realistic slot commitments and well-defined escalation points in peak periods are essential to the long-term success of your outsourcing relationship.
 

Common Buyer Mistakes in Packaging Outsourcing

Early alignment of serialization data flow, artwork governance and release timelines for QA is often underestimated by buyers. Buyers who select partners based primarily on price or location run the risk of having difficulty executing when they encounter an increase in regulatory complexity. Buyers must work with their partners through a structured onboarding process in order to eliminate delays later in the process.
 

Conclusion

As the role of your contract packaging and labelling partners becomes increasingly important in market access, compliance and supply continuity in 2026, we encourage buyers to evaluate partners based not only on price but also on their serialization capability, artwork control, minimum order quantity (MOQ) flexibility and capacity planning skills in order to limit their regulatory and operational risks.

The choice for buyers to outsource packaging should be based on finding a reliable regulatory extension of the buyer's supply chain, rather than on finding the least costly line.

Frequently Asked Questions(FAQs)

1. When should pharma companies outsource packaging and labelling?

Outsourcing is most effective when companies need flexibility, it is an essential aspect for many companies that wish to launch products in multiple countries because of the complexities of managing short production runs, tender supplies, and market-specific labeling. In addition, speed, scalability, and expertise related to the regulations in certain countries are often critical factors that influence businesses to outsource their packaging to fulfil orders from one source rather than invest in additional in-house lines.

2. What factors most influence the cost of contract packaging?

Numerous factors influence the costs associated with packaging, including pack complexity, batch size, SKUs (stock keeping units), varying designs for artwork, serialization, and quality assurance oversight. In addition, additional costs may be associated with setting up the production line, making revisions to artwork, and performing changeovers. Buyers should consider each of these costs when determining their total landed packaging costs.

3. What are typical MOQs for contract packaging and labelling?

MOQs (minimum order quantities) depend on how efficiently the production line operates, how the materials are sourced, and what kind of regulatory documentation is required for the product. While some packaging partners can accommodate small volumes for clinical or pilot batches, the vast majority of packaging operations require their partners to have considerably higher MOQs in order to remain viable from a cost perspective, especially for those businesses selling their products into serialized markets.

4. Why is serialization capability critical when selecting a packaging partner?

Since serialization is now a requirement in the majority of regulated markets, any delays in releasing product or launching product into the marketplace due to errors made in connection with serialization can expose a company to the risk of legal action or regulatory fines. Therefore, it is critical that your packaging partner have a solid understanding of how to properly and securely manage the assignment of serial numbers, the aggregation of serial numbers, and the secure transfer of data, without errors.

5. How can buyers reduce artwork and labelling risks?

Artwork risk is reduced by selecting partners with controlled artwork workflows, version management systems, and multi-level QA review. Clear ownership of artwork approvals and defined revision timelines further minimize the chance of errors and batch rejection.

6. What does “regulatory fit” mean for a packaging partner?

Regulatory fit refers to the partner’s experience with specific markets, authorities, and labelling rules, not just possession of a GMP certificate. Buyers should ensure the partner understands local requirements and maintains strong audit readiness and change-control discipline.

7. How should buyers evaluate a packaging partner’s capacity and scalability?

Buyers should assess current line availability, flexibility to handle multiple SKUs, and the partner’s ability to scale volumes or accommodate urgent orders. Transparent capacity planning and clear slot commitments are essential for avoiding supply disruptions.

8. What are common mistakes buyers make when outsourcing packaging?

Common mistakes include selecting partners based solely on price, underestimating serialization and artwork complexity, and failing to align early on QA release timelines. These gaps often result in delays, rework, or compliance issues later in the project.