Private Label & Own Brand Bag-on-Valve Products – Your Questions Answered

For distributors, pharmacies, and brand owners looking to bring a spray or medical device product to market without building manufacturing infrastructure, private label and own brand arrangements offer a fast, lower-risk path to market.

This guide answers the most common questions about private labeling for Aurena Bag-on-Valve saline and other sprays, with their superior usability, convenience, and sustainability attributes.

What does ‘private label’ mean for medical device sprays?

Private label manufacturing is also known as the Original Equipment Manufacturer (OEM) model.

At Aurena, “private label” and “OEM” describe the same arrangement, not two different models – the client sources an already-registered, already-approved product and applies their own branding to it.

This involves Aurena acting as more than a contract manufacturing organization producing devices and formulations to customer specification. Rather, it acts as a developer and original manufacturer, producing a range of innovative value-added spray products classified as medical devices, registered and approved (CE-marked) to which clients can then add their own branding to sell as their own products.

What’s the difference between private label and contract manufacturing?

These represent two distinct services Aurena offers, built around different levels of product development.

• Private Label / OEM: Aurena will be both legal manufacturer and OEM, adding a new label including the customer’s brand name to the existing product list and technical file for the already CE-marked product. This can happen very quicky, because the formulation, testing, and approval already exist.
• Contract Development and Manufacturing (CDMO): As a Contract Manufacturing Organization (CMO) and Contract Development and Manufacturing Organization (CDMO), Aurena can help the client develop its own innovative and creative solutions, with a proven manufacturing process that can transform customer formulations into modern spray delivery systems, with operations carried out in Karlstad, Sweden. This route is used when a brand wants a new or customized formulation, rather than an existing product. This naturally takes longer since it involves formulation and regulatory work from the ground up.

Who bears what responsibilities in a private label arrangement?

In this arrangement, Aurena will be both the legal manufacturer and the OEM. Aurena will take full responsibility as manufacturer and will be stated as manufacturer on the product, and all responsibilities towards the Notified Body and Competent Authorities fall on Aurena. A distributor whose name appears on the product will not be considered the manufacturer if it is clearly sold under the actual OEM manufacturer’s name and responsibility.

So, while Aurena bears responsibility for product quality, the client retains responsibilities for marketing that product in responsible ways, making sure, for instance, that it is accurately described.

This structure is what allows brand owners to launch under their own name without taking on the regulatory burden of being the manufacturer of record themselves.

Can I put my own brand name on an already CE-marked product?

Yes. A new label, including the customer’s brand name, is designed, and this artwork is added to the existing product list and technical file for the already CE-marked product. The underlying formulation, intended use, and technical specifications remain unchanged from the approved device – changes are limited to branding, artwork, and (where needed) translation.

Do I need my own CE-mark to sell a private label spray product?

No. Because Aurena remains the legal manufacturer and CE-mark holder for the underlying product, the distributor selling under their own brand does not need to obtain a separate CE-mark for that product. This is one of the main practical advantages of the private label route – it significantly reduces the regulatory burden and time investment for the brand owner, since the technical file, quality system compliance, and regulatory relationship with Notified Bodies remain with Aurena.

What’s involved in getting a new private label design approved?

Based on Aurena’s documented process, bringing a new private label design to market involves:

• Claims verification: Verifying that the product conforms with the brand’s intended claims.
• Artwork and translation: Development of new artwork, and if needed, language translation.
• Distribution & quality agreement: A distribution agreement is put in place between Aurena and the distributor, covering commercial conditions as well as traceability, vigilance, product changes, and post-market surveillance.
• Regulatory integration: Once the design of the new label is finalized, Aurena adds the new version to the product list of the original products, takes responsibility for ensuring the product complies with all requirements, and includes the new brand version in its ongoing regulatory work with Notified Bodies and Competent Authorities.

Exact turnaround times can vary, so brand owners with a specific launch window should confirm timelines directly with Aurena’s commercial team.

Is private label distribution exclusive or non-exclusive?

Private label sprays are “generic” versions of registered Aurena products and are normally provided to distributors on a non-exclusive basis. This means the same underlying product may be supplied to more than one distributor, potentially under different brand names in different markets, unless a specific exclusivity arrangement is separately negotiated.

How are quality and change issues handled under a private label agreement?

The division of responsibility is clear on the manufacturer side: all quality and product variation responsibilities towards the Notified Body and Competent Authorities fall on Aurena as the legal manufacturer. The distribution & quality agreement between Aurena and the distributor addresses commercial conditions alongside traceability, vigilance, product changes, and post-market surveillance.

The precise operational split – for example, exactly how a distributor should forward a customer complaint – isn’t detailed in Aurena’s public materials and is defined within the individual agreements. Brand owners should clarify these specific mechanics as part of that agreement rather than assume a standard process.

Do private label products require language translation for different markets?

Often, yes. Development of new artwork, and if needed, language translation, is a standard part of adapting a product for a new private label brand. Translated text and labeling are reviewed as part of getting the new brand version added to the technical file and included in ongoing regulatory work.

What products are available for private label from Aurena?

Aurena produces a wide range of trusted saline sprays for ear, nose and nasal applications, available in both hypertonic and isotonic formulae, and offers seawater nasal sprays for the whole family from infants to adults, with additives such as Aloe Vera and Chamomile. Aurena also offers sparkling drug-free nasal sprays combining saline with carbon dioxide.

Beyond ENT products, Aurena has developed a range of wound and skin care products including sterile wound wash and irrigation sprays, medical adhesive remover sprays, and burn gel spray for rapid pain relief. Aurena also offers first aid products including CE-marked eyewash, burn gel, and combined wound and eyewash sprays available as OEM products for markets such as occupational safety, law enforcement, rescue services, and sporting.

Apart from the high quality of these various formulations, they share added value in their Bag-on-Valve (BoV) packaging that enhances purity, eliminates propellants, makes administration easier, and is more environmentally friendly.

Because the exact portfolio and market-by-market availability can change, brand owners interested in a specific category should confirm current availability directly with Aurena.