You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 19, 2025

Suppliers and packagers for generic pharmaceutical drug: FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL


✉ Email this page to a colleague

« Back to Dashboard


FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Fresenius Kabi Usa SMOFLIPID 20% fish oil; medium chain triglycerides; olive oil; soybean oil EMULSION;INTRAVENOUS 207648 NDA Fresenius Kabi USA, LLC 63323-820-00 10 BAG in 1 CASE (63323-820-00) / 100 mL in 1 BAG (63323-820-01) 2016-07-13
Fresenius Kabi Usa SMOFLIPID 20% fish oil; medium chain triglycerides; olive oil; soybean oil EMULSION;INTRAVENOUS 207648 NDA Fresenius Kabi USA, LLC 63323-820-10 6 BAG in 1 CASE (63323-820-10) / 1000 mL in 1 BAG (63323-820-05) 2016-07-13
Fresenius Kabi Usa SMOFLIPID 20% fish oil; medium chain triglycerides; olive oil; soybean oil EMULSION;INTRAVENOUS 207648 NDA Fresenius Kabi USA, LLC 63323-820-12 20 BAG in 1 CASE (63323-820-12) / 100 mL in 1 BAG (63323-820-02) 2016-07-13
Fresenius Kabi Usa SMOFLIPID 20% fish oil; medium chain triglycerides; olive oil; soybean oil EMULSION;INTRAVENOUS 207648 NDA Fresenius Kabi USA, LLC 63323-820-50 12 BAG in 1 CASE (63323-820-50) / 500 mL in 1 BAG (63323-820-03) 2016-07-13
Fresenius Kabi Usa SMOFLIPID 20% fish oil; medium chain triglycerides; olive oil; soybean oil EMULSION;INTRAVENOUS 207648 NDA Fresenius Kabi USA, LLC 63323-820-74 10 BAG in 1 CASE (63323-820-74) / 250 mL in 1 BAG (63323-820-04) 2016-07-13
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Ingredients: Fish Oil, Medium Chain Triglycerides, Olive Oil, and Soybean Oil

Last updated: July 31, 2025

Introduction

The demand for high-quality pharmaceutical-grade ingredients such as fish oil, medium chain triglycerides (MCTs), olive oil, and soybean oil has surged in recent years. These ingredients serve as vital components in a range of medical formulations, dietary supplements, and neutraceuticals. Securing reliable suppliers capable of meeting stringent pharmaceutical standards is crucial for manufacturers aiming to uphold product quality, regulatory compliance, and market competitiveness. This comprehensive overview delineates prominent suppliers and manufacturing sources globally recognized for their excellence in sourcing, quality assurance, and supply stability for these key oils.


Fish Oil Suppliers

Overview

Fish oil, rich in omega-3 fatty acids like EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), is a cornerstone in cardiovascular and cognitive health products. The criticality of purity, freshness, and contaminant-free profiles necessitates sourcing from reputable suppliers.

Leading Suppliers

  1. Croda International Plc

    • Known for sustainable sourcing and pharmaceutical-grade fish oils.
    • Offers tailored omega-3 concentrates meeting pharmaceutical standards.
    • Certifications: ISO 9001, ISO 22000, and stringent contaminant testing protocols.
  2. GC Rieber Oils

    • Norwegian supplier with over 50 years of experience.
    • Specializes in pharmaceutical-grade fish oils with high EPA/DHA purity.
    • Emphasizes sustainable sourcing from wild-caught anchovies and sardines.
  3. EPAX AS

    • Norwegian company focusing exclusively on high-quality omega-3 concentrates.
    • Supplied to pharmaceutical, nutraceutical, and functional food markets.
    • Certified GMP, HACCP, and environmentally sustainable practices.
  4. Nordic Naturals

    • Provides pharmaceutical-grade fish oils with rigorous testing for heavy metals and PCBs.
    • Global distribution with a focus on purity and sustainability.

Medium Chain Triglycerides (MCTs) Suppliers

Overview

MCTs, primarily derived from coconut oil and palm kernel oil, are valued in medical nutrition for their rapid absorption and metabolic benefits.

Leading Suppliers

  1. shows the importance for pharmaceutical applications that MCT oils are produced under Good Manufacturing Practices (GMP).

  2. Cargill, Inc.

    • Produces pharmaceutical-grade MCT oils through extensive refining processes.
    • Certifications: ISO 9001, GMP for Pharmaceuticals.
    • Supplies customized MCT blends with high caprylic and capric acid content.
  3. Kerry Group

    • Offers MCT oils with strict purity standards suitable for medical use.
    • Focuses on sustainable sourcing from coconuts and ensuring contaminant-free profiles.
  4. Connoils LLC

    • Specializes in pharmaceutical-grade MCT oils with GRAS status.
    • Provides high-purity, allergen-free MCT oils with batch-specific testing results.

Olive Oil Suppliers

Overview

Extra virgin olive oil (EVOO) is utilized both in pharmaceutical formulations and nutritional applications, often for its antioxidant properties and as a carrier oil.

Leading Suppliers

  1. Davidsteins

    • Supplies pharmaceutical-grade EVOO compatible with GMP standards.
    • Focuses on traceability, quality assurance, and chemical purity.
  2. LIDIA'S

    • Offers EVOO with high polyphenol content, suitable for medical formulations.
    • Certified by global quality standards (ISO, HACCP).
  3. Partnerships with Mediterranean producers (e.g., Spain, Italy)

    • Large-scale suppliers sourcing directly from certified groves, ensuring quality control.
    • Emphasize harvests adhering to organic and sustainable practices.
  4. Corbion

    • Provides refined olive oils meeting pharmaceutical specifications for use in compounded medicines.

Soybean Oil Suppliers

Overview

Soybean oil serves as a carrier and excipient in pharmaceutical applications and dietary supplements. Its suitability depends on its refining process, allergen management, and contaminant control.

Leading Suppliers

  1. Archer Daniels Midland Company (ADM)

    • One of the world's largest soybean oil producers.
    • Offers refined, deodorized, and bleached soybean oil suitable for pharmaceutical use.
    • Certifies compliance with FDA and other regulatory standards.
  2. Cargill, Inc.

    • Supplies pharmaceutical-grade soybean oil extracted and refined per GMP standards.
    • Emphasizes contaminant removal, including pesticides and heavy metals.
  3. Bunge Limited

    • Provides soybean oil complying with international pharmaceutical specifications.
    • Focus on sustainable sourcing and traceability.
  4. Wilmar International

    • Global supplier offering refined soybean oils tailored for pharmaceutical applications.

Sourcing Considerations and Certification Standards

Procurement of pharmaceutical ingredients demands adherence to stringent quality standards, including:

  • GMP Compliance: Ensures consistent quality in manufacturing processes.
  • ISO Certifications: Demonstrate adherence to international quality management systems.
  • Heavy Metal & Contaminant Testing: Regular testing for PCB, mercury, lead, and other toxins.
  • Traceability & Sustainability: Certification such as MSC (Marine Stewardship Council) for fish oils, RSPO (Roundtable on Sustainable Palm Oil), and organic certifications for plant oils.
  • Regulatory Approval & Documentation: Certificates of Analysis (COA), Goods Manufacturing Practice certifications, and batch traceability.

Emerging Suppliers and Market Trends

Innovative suppliers employing sustainable and environmentally friendly extraction methods are gaining prominence. Companies utilizing supercritical CO₂ extraction or enzymatic processes enhance purity while reducing chemical solvents. Additionally, suppliers aligned with organic and non-GMO standards are increasingly preferred in global markets.


Conclusion

Securing reliable, high-quality suppliers for fish oil, MCTs, olive oil, and soybean oil is fundamental for pharmaceutical product integrity. Leading suppliers like Croda, GC Rieber Oils, EPAX, Cargill, ADM, and others demonstrate comprehensive compliance with pharmaceutical standards, sustainability commitments, and supply stability. Engaging with these suppliers requires meticulous due diligence, including verification of certifications, testing protocols, and traceability practices. As the demand for plant-based and sustainable ingredients expands, partnerships with innovators in sourcing and extraction will prove advantageous.


Key Takeaways

  • Regulatory Compliance Is Critical: Select suppliers with GMP, ISO certifications, and comprehensive testing protocols to meet pharmaceutical standards.
  • Sustainability Matters: Engage suppliers with sustainable sourcing practices; certifications like MSC and RSPO ensure long-term supply and environmental responsibility.
  • Quality Assurance Is Non-Negotiable: Always verify Certificates of Analysis, contaminant testing, and batch traceability before procurement.
  • Market Dynamics Favor Innovation: Emerging extraction methods and organic certifications are increasingly valuable differentiators.
  • Global Sourcing Offers Diversification: Building a diversified supplier base mitigates risks related to regional disruptions or quality issues.

FAQs

1. How can I verify the quality and purity of fish oil suppliers?
Obtain detailed Certificates of Analysis that include testing for heavy metals, PCBs, and rancidity. Verify adherence to pharmacopeial standards (e.g., USP, EP). Conduct supplier audits and consider third-party testing.

2. Are plant-based oils like olive and soybean oil suitable for pharmaceutical formulations?
Yes, provided they meet strict quality standards, contaminant-free profiles, and are processed according to GMP. Certifications such as ISO and HACCP validate suitability.

3. What sustainability certifications should I look for in sourcing MCTs and fish oils?
Look for MSC (Marine Stewardship Council) for fish oils, RSPO (Roundtable on Sustainable Palm Oil) for palm-derived MCTs, and organic or Rainforest Alliance certifications for plant oils.

4. How do regulatory standards differ across suppliers?
Suppliers compliant with FDA cGMP, EU GMP, and ISO standards are preferable. Always request documentation and conduct audits to confirm compliance with relevant regulations.

5. What are emerging trends in sourcing pharmaceutical oils?
Increased emphasis on organic, non-GMO, and sustainable sourcing; adoption of green extraction technologies; and development of highly purified, allergen-free formulations are shaping future sourcing strategies.


References

[1] Croda International Plc. Fish oils: https://www.croda.com/en-GB/products/speciality-ingredients/fish-oils
[2] GC Rieber Oils. About us: https://www.gcrober.com/about-us/
[3] EPAX. Omega-3 concentrates: https://www.epax.com/
[4] Nordic Naturals. Product quality: https://www.nordicnaturals.com/
[5] Cargill. MCT oils: https://www.cargill.com/
[6] ADM. Soybean oil specifications: https://www.adm.com/
[7] RSPO Certification Program: https://rspo.org/
[8] ISO Standards: https://www.iso.org/

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing