Pharmaceuticals

Pharmaceuticals

With more than 180 years of experience in innovating omega-3s BASF is your preferred partner for end-to-end solutions.

Pronova BioPharma Norge AS, now a BASF company, created the omega-3 market by introducing Omacor® in 1994 as the world’s first omega-3 drug product.

BASF’s process expertise and manufacturing capabilities make us the preferred partner for developing high-concentrate omega-3 solutions. Featuring a wide portfolio of products to fit all the needs in the pharma and nutrition industries, BASF makes sure its customers get the best omega-3 fatty acid formulations and breakthrough technologies.

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Omega-3 products from BASF

In this video, you will find information about omega-3 products from BASF, our omega-3 manufacturing sites Sandefjord, Norway and Callanish, Scotland, and our headquarter at Lysaker, Norway.

Learn about our sustainability actions at the sites and how we are positively impacting the entire value chain. You will also get insights on the key benefits for our customers and information about our omega-3 expert teams.

BASF is the supplier of choice for Omega-3s

Leaders In Regulatory Procedures
BASF’s experienced regulatory staff work exclusively with omega-3 products and support all regulatory activities. BASF has more than 25 years of experience with regulatory procedures in the U.S., Europe and the rest of the world.
This experience combined with regulatory intelligence and awareness enable us to set regulatory strategies and be advisors for internal and external projects and partners. BASF knows the processes and works closely together with manufacturing sites to find the best solutions for products. 
Supply Chain Support
BASF collaborates with the biggest logistic providers and has developed a deep understanding and expertise in customs and foreign-trade regulations.
  • You enjoy optimized import and export conditions with the most competitive shipment terms and conditions
  • You have a dedicated contact person following the whole value-chain
  • Your team profits from knowledge-transfer and our expertise
  • We can manage and monitor logistics until product delivery to your warehouse
  • You enjoy peace of mind with regards to supply & deliverable reliability
Quality Assurance
Verified by our track-record with originator products.

Our processes are subject to stringent regulatory control and manufacturing facilities are inspected by authorities on a regular basis. Our quality system complies with EU, US, Japan and other applicable Good Manufacturing Practice guidelines. The production of omega-3 nutritional products is certified according to FSSC 22000.
Pharmaceutical Product Safety Monitoring System
Patient safety has the highest priority for us and we have an established safety monitoring system in place to comply with current guidelines.

All marketing authorization holders in EU/EEA are obliged to have a pharmacovigilance (PV) system in place and to describe all activities within the PV system in a PV master file. The purpose of the PV system is to monitor the safety of authorized medicinal products and detect any change to the risk-benefit balance.

BASF is your supplier for more sustainable Omega-3s

Sourcing
We source responsibly.

With an established and comprehensive fish oil sourcing policy, we minimize our impact on the oceans.
We require the fisheries we source from to have a 3rd-party certification of sustainable practices. Our suppliers are also required to provide traceability of their fish oil to the vessel, fish species, and catch area, period, and method.
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BASF produces Omega-3 solutions for the pharma API and the nutritional supplement markets

More About Omega-3 Pharma

BASF’s omega-3-based API is approved for use in drug products in approximately 70 countries worldwide. 

More than 100,000 patients have been included in clinical trials with the API globally. Our global safety database covers more than 11 million patient years.

Product CAS no. BASF Product name Registration Monograph
Omega-3-acid ethyl esters 90 EPA EE 86227-47-6, DHA EE 81926-94-5 K85EE Omega-3-acid Ethyl Esters CEP, US-DMF, J-DMF, KR-DMF and CN-DMF USP, Ph.Eur.
Eicosapentaenoic acid ethyl ester 86227-47-6 Maxomega EPA 96/97 EE J-DMF, US-DMF, CN-DMF, IN-DMF JP
Omega-3 acid triglycerides 10417-94-4 (EPA), 6217-54-5 (DHA) CN 600 TG Omega-3-acid triglycerides CEP, CN-DMF Ph.Eur.
Docosahexaenoic acid ethyl ester DHA EE 81926-94-5 Maxomega DHA 95 EE AS US-DMF in preparation

 

Need on-demand regulatory support?

Access quality and regulatory information in a document library to help fulfill your compliance needs quickly.

More About Omega-3 Nutrition

BASF provides highly concentrated omega-3 fatty acids with an outstanding purity and potency profile.

With more than 180 years experience, we are one of the key industry partners for solutions in the dietary supplement market.

Product EPA mg/g DHA mg/g EPA&DHA mg/g
PronovaPure® 360:240 EE min. 360 min. 240 min. 600
PronovaPure® 360:240 TG min. 360 min. 240 min. 600
PronovaPure® 150:500 EE min. 150 min. 500 min. 650
PronovaPure® 150:500 TG min. 150 min. 500 min. 650
PronovaPure® 500:200 EE min. 500 min. 200 min. 700
PronovaPure® 500:200 TG min. 500 min. 200 min. 700
PronovaPure® 460:180 EE min. 460 min. 180 min. 640
PronovaPure® 46:38 EE min. 430 min. 347 min. 800
PronovaPure® 400:200 EE min. 400 min. 200 min. 600
PronovaPure® 400:200 TG min. 400 min. 200 min. 600

EE ethyl ester, TG triglyceride

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Have questions about our Omega-3 products?
BASF’s team of experts is here to answer all of your questions. 

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