The pharmaceutical market is evolving at a rapid pace. Faced with cost pressures, supply delays, stockouts, and increasing customization requirements, more and more pharmaceutical groups are seeking to diversify their industrial partners. And this happens, in an assumed manner, through manufacturers located outside Europe, provided they offer the right guarantees.
Long considered a guarantee of absolute safety, the “Made in EU” label is now showing its limitations. Recent recalls of batches of saline solutions manufactured in Europe have only reinforced this awareness.
In this article, we analyze why industry players are rethinking their supply chain, and what qualities they expect from their future white label manufacturer.
1. The price factor: an obvious lever but not the only one
For several years, the economic pressure on pharmacies and laboratories has been real. Groups are seeking to preserve their margins while remaining competitive.
Basic products — such as physiological serum, THE wet wipes, or the first aid — represent a clear lever for optimization. Manufactured internationally in certified factories, these products can be sold at significantly more competitive prices… without compromising on quality, if the process is controlled.
But be careful: price is just a starting pointWhat the groups are looking for today is good value for money and service.
2. Deadlines, volumes, flexibility: the advantages of non-European factories
One of the major obstacles to European manufacturers is their lack of industrial flexibility :
- Production times too long
- High minimum order quantities
- Limited capacity to adapt to peak demand
- Difficulty in customizing packaging or instructions
Conversely, many factories located in Asia, trusted partners, offer a high operational flexibility :
- Custom manufacturing, including small batches
- Shorter lead times thanks to improved production capacity
- Rapid packaging/branding adjustment for private labels
- Responsiveness in the event of a campaign or regulatory change
👉 This is this industrial agility that decision-makers in groups are looking for today.
3. The shock of the May 2025 recall: the end of the European myth?
In May 2025, several batches of physiological serums were recalled by the ANSM. The brands concerned — Happylab, Thusfont, GSL, Mediphysio, Stentil — were all marketed in pharmacies… and for some, associated with a supposedly controlled circuit in Europe.
Problem: traces of cleaning alcohol were detected in the bottles, following poor management of the cleaning of the manufacturing tanks.
💡 This recall had a catalytic effect on the sector. It showed that the “made in Europe” label was no longer enough to guarantee quality, if internal processes are not rigorously validated, documented and monitored.
Today, B2B buyers are much more lucid. They no longer look at location, but at real quality structure from the manufacturer.
4. What the groups really want today
A competitive manufacturer, yes. But above all a reliable, structured, professional partner.
Here are the concrete expectations expressed:
- CE compliant, sterile products with up-to-date documentation
- ISO certificates (13485, 14971, 10993, etc.)
- Ability to deliver quickly (controlled logistics)
- Dedicated French-speaking contact person
- Packaging / branding adaptability
- Visibility on costs and deadlines
Groups are not just looking to buy a product: they want outsource part of their value chain to a trusted partner.
5. Certification, traceability and transparency: the real value
It does not matter whether the product is manufactured in Lisbon, Guangzhou or Warsaw if:
- It is ISO certified
- The quality process is documented
- Raw materials are traced
- The lots are tracked
- The tests are validated
- And audits can be conducted at any time
👉 These are the elements that make the difference between a simple supplier… and a true partner manufacturer.
6. The Smart Agents Healthcare example
At the house of Smart Agents Healthcare, we have been supporting laboratories, distributors and groups for over 15 years in the manufacturing their white label medical devices, at competitive costs, but always with:
- ISO 13485 certified partner factories
- CE compliant products (physiological serum, wipes, care products, etc.)
- Rigorous quality control at every stage
- Complete traceability and audit possible
- Complete support: from design to after-sales service
We are not a supplier, but a structured pharmaceutical factory agent for the requirements of the health sector.
Conclusion: an inevitable industrial evolution
Faced with economic constraints, logistical delays and quality defects even within Europe, Pharmaceutical groups have every interest in broadening their industrial horizons.
The right partner is not the one who manufactures “in France” or “in Germany”, but the one who:
- masters its processes
- documents each step
- adapts to the reality on the ground
- and delivers what he promises, on time
By choosing a certified and experienced manufacturer outside Europe, groups can secure their supply, optimize their costs And better meet the expectations of their members.
