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Suppliers and packagers for generic pharmaceutical drug: OLIVE OIL; SOYBEAN OIL
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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 |
|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare Corp | CLINOLIPID 20% | olive oil; soybean oil | EMULSION;INTRAVENOUS | 204508 | NDA | Baxter Healthcare Corporation | 0338-9540-05 | 15 BAG in 1 CARTON (0338-9540-05) / 100 mL in 1 BAG (0338-9540-01) | 2016-01-01 |
| Baxter Hlthcare Corp | CLINOLIPID 20% | olive oil; soybean oil | EMULSION;INTRAVENOUS | 204508 | NDA | Baxter Healthcare Corporation | 0338-9540-06 | 10 BAG in 1 CARTON (0338-9540-06) / 250 mL in 1 BAG (0338-9540-02) | 2016-01-01 |
| Baxter Hlthcare Corp | CLINOLIPID 20% | olive oil; soybean oil | EMULSION;INTRAVENOUS | 204508 | NDA | Baxter Healthcare Corporation | 0338-9540-07 | 12 BAG in 1 CARTON (0338-9540-07) / 500 mL in 1 BAG (0338-9540-03) | 2016-01-01 |
| Baxter Hlthcare Corp | CLINOLIPID 20% | olive oil; soybean oil | EMULSION;INTRAVENOUS | 204508 | NDA | Baxter Healthcare Corporation | 0338-9540-08 | 6 BAG in 1 CARTON (0338-9540-08) / 1000 mL in 1 BAG (0338-9540-04) | 2016-01-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: Olive Oil and Soybean Oil
Introduction
Olive oil and soybean oil are widely used excipients and raw materials in pharmaceutical formulations, appreciated for their biocompatibility, stability, and functional properties. As demand surges driven by pharmaceutical innovations—particularly in drug delivery, encapsulation, and topical applications—identifying reputable suppliers becomes vital for manufacturers seeking consistent quality and supply chain reliability. This analysis explores the leading suppliers for pharmaceutical-grade olive and soybean oils, emphasizing global market dynamics, quality standards, and sourcing strategies.
Olive Oil Suppliers in the Pharmaceutical Industry
Market Overview
Olive oil's utilization in pharmaceuticals hinges on its purity, stability, and bioavailable properties. Extra virgin olive oil, characterized by minimal processing, is predominantly preferred in formulation due to its antioxidant profile and inert characteristics. Pharmaceutical-grade olive oil demands strict compliance with standards such as the United States Pharmacopoeia (USP) and European Pharmacopoeia (EP) to ensure safety, purity, and functional consistency.
Leading Suppliers
-
Fiorucci (Italy)
A longstanding supplier with a deep heritage in olive oil production, Fiorucci offers pharmaceutical-grade extra virgin olive oil compliant with industry standards. Their quality control integrates rigorous testing for pesticides, heavy metals, and peroxide values, making it suitable for pharmaceutical formulations requiring high purity. -
Farchioni Olio d’Oliva (Italy)
Specializes in extra virgin olive oil with certifications compliant with ISO 9001 and food/pharmaceutical quality standards. Their products undergo comprehensive chemical and microbiological testing, ensuring suitability for drug delivery systems. -
Minerva S.p.A. (Italy)
Renowned for certified organic olive oils adhering to pharmacopeial standards. Minerva emphasizes sustainability and purity, supplying oils suitable for pharmaceutical and cosmetic applications. -
Cortas (Lebanon)
Offers pharmaceutical-grade olive oil with global distribution capabilities, maintaining high purity standards suitable for compounding pharmacies and manufacturing units. -
Centro Olivicolo Toscano (Italy)
Specializes in premium extra virgin olive oils, meeting strict quality benchmarks necessary for pharmaceutical and nutraceutical applications.
Regional Suppliers
- Spain (e.g., Carrefour Agroalimentaria, Almazaras de la Subbética)
- Greece (e.g., Kalamata Olive Oil Producers)
These regions produce vast quantities of high-quality olive oils, often complying with phytosanitary and pharmacopoeial standards for pharmaceutical use when properly processed and certified.
Soybean Oil Suppliers in the Pharmaceutical Industry
Market Overview
Soybean oil's extensive application in pharmaceuticals primarily involves as an excipient in emulsions, injectable formulations, and capsule fillings. The critical quality parameters for pharmaceutical soybean oil include low peroxide values, minimal free fatty acids, and absence of trans fats. Compliance with Pharmacopoeial standards like USP <729> and EP ensures safety and efficacy.
Leading Suppliers
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Cargill, Inc. (USA)
A global leader in vegetable oils, Cargill supplies pharmaceutical-grade soybean oil produced under stringent quality controls, adhering to FDA and USP standards. Their vertically integrated operations ensure traceability, quality assurance, and consistent supply. -
Archer Daniels Midland Company (ADM) (USA)
Offers pharmaceutical-grade soybean oil with certifications aligning with international pharmacopoeial standards. ADM’s extensive refining capacity ensures oils are free of contaminants, trans fats, and suitable for injectable and oral formulations. -
Wilmar International (Singapore)
Provides high-quality soybean oil tailored for pharmaceutical applications, emphasizing purity and compliance with global standards like the FAO/WHO Codex Alimentarius. -
Bunge Limited (USA)
Offers refined soybean oil for pharmaceutical manufacturing, with a focus on low peroxide and free fatty acid levels, meeting strict pharmacopoeial specifications. -
Louis Dreyfus Company (Netherlands)
Provides pharmaceutical-grade soybean oils, emphasizing quality control, traceability, and adherence to safety standards for injectable and oral drug excipients.
Regional and Specialized Suppliers
- South American producers (Brazil, Argentina): Leading in soybean cultivation, these suppliers can provide raw materials for further refining into pharmaceutical-grade oils.
- European refiners: Focus on meticulous refining and quality control processes suitable for pharmaceutical needs.
Sourcing Strategies and Quality Compliance
Certification and Quality Assurance
Before procurement, ensure suppliers hold certifications such as ISO 9001, ISO 22000, GMP, and pharmacopoeial certifications (USP, EP, BP). Traceability, microbiological safety, and absence of contaminants are mandatory standards for pharmaceutical-grade oils.
Supply Chain Reliability
Long-term partnerships with reputable suppliers like Cargill, ADM, and Bunge can mitigate risks related to supply disruptions. Transparency in sourcing practices and consistent quality audits are crucial.
Regional vs. Global Suppliers
While regional suppliers might offer cost advantages, global leaders often guarantee faster compliance with regulatory standards and scalable quality assurance processes. For sensitive formulations, choosing suppliers with proven GMP compliance and extensive R&D support ensures product integrity.
Regulatory and Compliance Considerations
Pharmaceutical manufacturers must verify that olive and soybean oils comply with applicable pharmacopeias, including testing for pesticides, residual solvents, heavy metals, and microbial contaminants. Suppliers should provide Certificates of Analysis (CoA) and product traceability documentation. Regulatory approvals may vary across regions, necessitating comprehensive supplier due diligence.
Conclusion
The success of pharmaceutical formulations incorporating olive and soybean oils relies heavily on the quality and reliability of raw materials supplied by reputable manufacturers. Italy remains the hub for high-quality olive oil, with leading firms exemplifying excellence in purity and certification. American giants like Cargill and ADM dominate soybean oil provision, offering consistent, certified materials suitable for injection, oral, and topical products. Strategic supplier selection aligned with strict quality standards is essential for ensuring compliance, safety, and manufacturing efficiency in the pharmaceutical sector.
Key Takeaways
- Premium sourcing from established suppliers like Fiorucci, Minerva, Cargill, and ADM ensures product purity and regulatory compliance.
- Certification adherence (GMP, ISO, pharmacopoeial standards) is non-negotiable to meet pharmaceutical quality demands.
- Regional suppliers in the Mediterranean (olive oil) and South America (soybean oil) can provide high-quality raw materials when properly certified.
- Supply chain robustness reduces risks of shortages and ensures consistent batch-to-batch quality.
- Thorough due diligence—including testing, documentation, and audit processes—is essential for regulatory approval and product safety.
FAQs
Q1: Are all olive oils suitable for pharmaceutical applications?
No, only those that meet strict purity, stability, and certification standards such as USP or EP qualify as pharmaceutical-grade olive oils.
Q2: What certifications should suppliers provide for pharmaceutical soybean oil?
Suppliers should present Certificates of Analysis (CoA), GMP compliance, ISO 9001/22000, and pharmacopeial certifications verifying compliance with USP, EP, or other relevant standards.
Q3: Can regional suppliers meet pharmaceutical-grade specifications?
Yes, many regional producers in olive oil-rich Mediterranean countries and South America produce oils that meet pharmaceutical standards when subjected to appropriate refining, testing, and certification.
Q4: How do quality standards differ between culinary and pharmaceutical oils?
Pharmaceutical oils require rigorous testing for contaminants, controlled peroxide values, minimal free fatty acids, and strict adherence to pharmacopeial specifications, surpassing typical culinary quality metrics.
Q5: What are the risks of sourcing uncertified oils for pharmaceutical use?
Uncertified oils pose risks including contamination, inconsistent composition, regulatory rejection, and potential safety issues, jeopardizing product quality and approval.
Sources
[1] United States Pharmacopoeia (USP) Monographs.
[2] European Pharmacopoeia (EP).
[3] Cargill Corporate Responsibility Report.
[4] ADM Quality Assurance Documentation.
[5] Industry Reports on Vegetable Oil Sourcing and Quality Standards.
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