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QUALITY

QUALITY

Quality Never Stops

Quality Never Stops

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We believe that quality must be for everyone

With our exciting and engaging work, we want to bring the widest possible awareness about this paramount value to the world of phytochemistry.

For us, quality is not a special side project. It is an inclination, a daily practice, a constant, an unavoidable requirement for products, processes, technologies, services and solutions.

We always strive to dissect, analyze and constantly evolve our quality system, ensuring even greater fairness in the system itself.

Quality

Indena’s Commitment to Excellence

21st -Century Quality Management

Quality is at the very core of our business.

At Indena, we do not just meet quality standards—we set them. 

While API production follows established pharmaceutical regulations, our ingredients for medical devices, nutraceuticals, and cosmetics often exceed mandatory requirements, demonstrating our unwavering commitment to delivering superior quality across all product categories.

Our mindset

Quality Pathway Unlocked

The definition of quality extends beyond compliance.

A high-quality product is expected to deliver the intended benefits with reliability, consistency, and safety.

This philosophy guides our quality system across all manufacturing processes, ensuring that every product—from medical device ingredients to nutraceuticals and cosmetic ingredients—meets and often surpasses the applicable regulatory standards.

Quality Pathway Unlocked
quality-you-can-count-on-lg

Indena's Expertise

Quality You Can Count On

Indena plays a key role in the production and control of products for various global markets, including:

- Ingredients for medical devices
- Nutraceuticals
- Cosmetic ingredients
- Excipients for pharmaceutical and other uses
- APIs for pharmaceutical use

Our commitment to quality ensures that each product category meets stringent safety and performance criteria.
While APIs comply with strict pharmaceutical regulations, our ingredients for nutraceuticals, medical devices, and cosmetics adhere to even higher standards than required by law, reflecting our dedication to excellence.

The Active Pharmaceutical Ingredients

Active Pharmaceutical Ingredients (APIs)

While APIs are subject to stringent regulatory requirements set by global pharmaceutical authorities, Indena’s quality commitment does not stop there.

We implement full traceability from plant cultivation to final product, ensuring our APIs meet and exceed all harmonized cGMP guidelines and regulatory expectations.

Active Pharmaceutical Ingredients (APIs)
QUALITY IN MEDICAL DEVICE INGREDIENTS

QUALITY IN MEDICAL DEVICE INGREDIENTS

Ingredients used in medical devices must comply with strict safety regulations based on a risk-based classification system.

Our production process guarantees:

- Full traceability from raw materials to final product;
- Compliance with global medical device regulations;
- Customizable quality agreements that meet or exceed pharmaceutical standards for high-risk applications;
- Special considerations for injectable and implantable devices, where quality standards match or exceed pharmaceutical-grade requirements.

NUTRACEUTICALS OF BOTANICAL ORIGIN: BEYOND COMPLIANCE

NUTRACEUTICALS OF BOTANICAL ORIGIN: BEYOND COMPLIANCE

Nutraceutical ingredients must comply with international food legislation, including:

- The US Food Safety Modernization Act (FSMA) for the safety of finished nutraceuticals;
EU Food Safety Management Systems (FSMS), which integrate Good Health Practices (GHP) and Good Manufacturing Practices (GMP);
Rigorous Hazard Analysis and Critical Control Points (HACCP) protocols,

Our approach ensures that nutraceuticals not only meet but exceed food safety standards, providing consumers with scientifically validated, high-quality products.

EXCIPIENTS: MORE THAN JUST CARRIERS

EXCIPIENTS: MORE THAN JUST CARRIERS

Our excipients are designed to exceed conventional pharmaceutical standards. Depending on their intended use (parenteral, oral, etc.), our excipients follow cGMP guidelines and undergo rigorous quality control processes to ensure safety, purity, and functionality in various applications.

COSMETIC INGREDIENTS: ELEVATING BEAUTY STANDARDS

COSMETIC INGREDIENTS: ELEVATING BEAUTY STANDARDS

Cosmetic ingredients require an extraordinary level of quality to ensure safety and efficacy.

At Indena, we apply the same rigorous principles used in pharmaceutical manufacturing, ensuring:

- Purity and safety exceeding regulatory minimums;
- Scientifically backed formulations;
- Traceability and sustainable sourcing.

THE 10 DIMENSIONS OF QUALITY

Indena applies a multidimensional approach to quality, ensuring our products surpass industry standards across various attributes:


1. COMPLIANCE WITH LAWS AND REGULATIONS

Meeting and exceeding regional and global requirements.

2. LABEL PERFORMANCE

Ensuring product efficacy throughout its lifespan.

3. CONFORMANCE

Maintaining consistency across batches.

4. LACK OF CONTAMINATION

Preventing toxic contaminants from entering the supply chain.

5. RELIABILITY

Reducing failure rates and ensuring consistency.

6. DURABILITY

Guaranteeing product longevity.

7. AVAILABILITY

Ensuring a stable and efficient supply chain.

8. FEATURES

Enhancing products with innovative characteristics.

9. SERVICEABILITY

Providing customer support and technical expertise.

10. PERCEIVED QUALITY

Building trust through transparent and superior quality assurance.

Our mindful innovation

Tools Toward Total Quality

Indena embraces innovation in quality control, shifting from a traditional product testing approach to a proactive Quality by Design (QbD) strategy. This approach ensures defects are prevented rather than detected, integrating quality into every stage of production.

Indena embraces innovation in quality control, shifting from a traditional product testing approach to a proactive Quality by Design (QbD) strategy. This approach ensures defects are prevented rather than detected, integrating quality into every stage of production.

As part of this ongoing transformation, Indena has successfully implemented the TrackWise Quality Management System (QMS) across its global network by the end of 2024. 
This strategic milestone enhances the management of key quality processes—such as Change Control, Deviations, CAPA, Audits, Supplier Management, OOS, Returns, and Complaints—while strengthening data integrity and harmonization across all sites.

Now fully operational at our facilities in Italy, France, and India, the system supports our commitment to regulatory compliance, operational excellence, and continuous improvement.
With TrackWise, Indena further empowers its teams with greater transparency and efficiency, reinforcing a proactive, integrated approach to quality on a global scale.

IN DNA

Making an even better product

DNA BARCODING

Indena successfully faced a market need for regulation by investing in technology: following a scandal in the supplement industry, the American market decided to develop genomic identification tests for natural products.
This challenge led to an innovative intuition: genomic analysis as an easy tool to directly verify a plant’s authenticity. Today, Indena identifies every plant coming into the company using genomic technology.

DNA BARCODING
The potential pitfall

The potential pitfall

BOTANICAL DNA ID

There is no check for origin in the DNA genomic data deposited in public databases (e.g. Genbank): the system lacks “reference” DNA profiles deriving from the analysis of plant samples of known, certified origin such as herbariums and taxonomically identified specimens.Therefore, it is of paramount importance to have certified, pure samples in order to derive reference DNA sequences. Building a solid genomic database is essential for us to produce species-specific methods, which can distinguish one particular plant from another and thus from adulterants.

The six points of proof

The six points of proof

INDENA’S APPROACH TO GENOMIC IDENTIFICATION

DNA barcoding is orthogonal: a single technique may not be enough. A strong botanical background to structure DNA methodologies. Leverage the ability to use the whole range of available DNA techniques. Use authenticated plant material to develop highly reliable DNA tests. Carefully define where, when and how to collect the reference species to be used as “certified” controls to validate DNA methods. Develop the ability to identify unknown species.

The Indena DNA label

The Indena DNA label

INDENA GENETICALLY CERTIFIES THE PLANTS IT USES

In consideration of the importance of plant DNA testing within the Indena quality system, and in order to communicate such analyses in a way that is more immediate and easy to use by clients, Indena developed the specific IN-DNA logo

DNA BARCODING: Plants & Extracts

DNA BARCODING: Plants & Extracts
THE CHALLENGE

DNA Testing Of Extracts

First application: MIRTOSELECT® - Bilberry Extract
The key to our method's success is that the amplified region must be univocal for Vaccinium myrtillus.

DNA Testing Of Extracts

bCUBE

One step beyond

On-Site DNA Analysis

Indena holds preferential access to breakthrough technology
for the on-site identification of botanical species, exclusively for the food supplement ingredient industry.

The device that makes this possible is the bCUBE®*, made by Hyris Ltd.
Through an exclusive agreement, and drawing from the solid Indena database of references Indena has compiled over decades, DNA fingerprint analysis on plant samples can be carried out
in the field, even by unskilled personnel.




*bCUBE® is a registered trademark of Hyris Ltd

On-Site DNA Analysis
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