Bulk Pharmaceutical API Sources for OXYTOCIN 20 USP UNITS IN DEXTROSE 5%

Bulk Pharmaceutical API Sources for OXYTOCIN 20 USP UNITS IN DEXTROSE 5%

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		O3251_SIGMA
Sigma-Aldrich		O4375_SIGMA
Sigma-Aldrich		O6379_SIGMA
NovoSeek		439302
Ambinter		HS-2021

Bulk Active Pharmaceutical Ingredient (API) Sources for Oxytocin 20 USP Units in Dextrose 5%

Last updated: July 30, 2025

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Introduction

Oxytocin, a peptide hormone used primarily to induce labor and control postpartum hemorrhage, is a critical component in obstetric and gynecological care. Its manufacturing quality, sourcing, and regulatory compliance are pivotal to ensuring efficacy and safety. For pharmaceutical companies and compounding pharmacies, sourcing high-quality bulk Active Pharmaceutical Ingredient (API) is essential in preparing final formulations such as Oxytocin 20 USP Units in Dextrose 5%. This article explores the global API sources, quality considerations, regulatory aspects, and strategic sourcing options critical to the safe procurement of oxytocin API.

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Understanding Oxytocin API and Its Specifications

Oxytocin is synthesized as a peptide hormone with a molecular weight of approximately 1,007 Daltons, composed of nine amino acids. The API specifications mandate strict purity standards, typically verified through assays such as High-Performance Liquid Chromatography (HPLC), peptide integrity, microbial purity, endotoxin levels, and stability parameters [1].

The USP monograph for oxytocin specifies Urine Units, with 20 USP Units equating roughly to a specific activity (approximately 1.5 IU per mg), translating to potency requirements essential for therapeutic consistency [2].

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Global API Manufacturing and Supply Sources

1. Established Multinational API Manufacturers

Numerous reputable pharmaceutical API manufacturers globally supply oxytocin API that complies with international quality standards, including USP, EP, and JP monographs:

• Ferring Pharmaceuticals (Sweden): A leader in peptide synthesis, Ferring produces high-purity oxytocin API used widely in hospital and compounded formulations. Their manufacturing facilities adhere to cGMP standards and hold multiple regulatory approvals worldwide.

• Sanofi (France): With an extensive peptide manufacturing portfolio, Sanofi supplies quality-certified oxytocin API, meeting stringent pharmacopeial specifications.

• Peptron Inc. (South Korea): Specializing in peptide APIs, Peptron offers synthetic peptides including oxytocin, with certifications supporting cGMP compliance.

• PolyPeptide Group (Sweden/Denmark): Known for custom and large-scale peptide production, PolyPeptide supplies globally with a focus on strict regulatory adherence.

• Otsuka Pharmaceutical (Japan): Engages in peptide API production, with a focus on high purity and consistent activity.

2. Emerging and Regional Manufacturers

Regional API manufacturing is growing, especially in Asia, where quality standards are increasingly aligning with international regs:

• Shanghai SIPPS (China): A GMP-compliant manufacturer producing peptide APIs, including oxytocin, often exported to global markets.

• Zhejiang Hisun Pharmaceutical (China): Offers synthetic peptide APIs with regulatory licenses suitable for pharmaceutical-grade production.

• Hapclor Ltd. (India): Provides peptide APIs, including oxytocin, with certifications aligning with WHO prequalification and other regulatory bodies.

3. Considerations in Selecting API Suppliers

• Regulatory Compliance: Suppliers with current cGMP certification, relevant regulatory approvals, and compliance with pharmacopoeia monographs (USP, EP, JP).

• Quality Certifications: ISO certifications, quality control documentation, batch consistency, and reliability in delivery timelines.

• Traceability and Documentation: Robust supply chain documentation, analytical reports, and Certificates of Analysis (CoA).

• Price and Lead Time: Balancing cost-efficiency with quality and logistical considerations.

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Quality and Regulatory Considerations

For pharmaceuticals incorporating oxytocin API, regulatory compliance is critical:

• GMP Certification: Ensures consistent quality; vital for APIs used in sterile or injectable formulations.

• Pharmacopoeial Compliance: The API must meet USP monograph standards, including potency, purity, endotoxin levels, and peptide integrity.

• Regulatory Approvals: APIs intended for global markets must come from suppliers with registration or approval from agencies such as the FDA, EMA, or PMDA.

• Stability and Storage: API suppliers should provide stability data under specified storage conditions to ensure potency over shelf life.

• Traceability: Complete documentation trail from manufacturing batch to final delivery reduces regulatory risks.

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Sourcing Strategies for Oxytocin API

1. Direct Procurement from Manufacturers

Engaging directly with manufacturers ensures quality control and potentially lowers costs, provided the buyer has the necessary regulatory infrastructure to validate compliance and quality.

2. Authorized Distributors and Importers

Working with authorized regional distributors who verify regulatory standards can facilitate procurement, especially for companies lacking direct manufacturing access.

3. Licensing and Contract Manufacturing

Some organizations secure licensing agreements or contract manufacturing arrangements, allowing for consistent, compliant access to APIs.

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Supply Chain and Risk Management

• Supply Security: Maintaining relationships with multiple verified suppliers mitigates risks of shortages.

• Quality Assurance: Regular audits, analytical testing, and batch-to-batch validation are indispensable.

• Regulatory Vigilance: Monitoring changes in regulations affecting API approval and documentation ensures ongoing compliance.

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Conclusion

Securing high-quality oxytocin API for pharmaceutical formulations like Oxytocin 20 USP Units in Dextrose 5% necessitates strategic sourcing from established, compliant manufacturers. With global suppliers spanning Europe, Asia, and North America, businesses must prioritize regulatory adherence, certification, quality assurance, and reliable supply chains. Proper due diligence ensures therapeutic efficacy and minimizes regulatory and safety risks.

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Key Takeaways

• High-purity oxytocin API is primarily sourced from reputable manufacturers with cGMP certification, adhering to pharmacopoeial standards such as USP.

• Asia-born APIs, notably from China and India, are increasingly complying with international standards, expanding global sourcing options.

• Due diligence in verifying regulatory compliance, quality certifications, and supply chain integrity is essential for procurement success.

• Developing relationships with multiple suppliers and maintaining rigorous quality assurance protocols mitigate supply chain disruptions.

• Ongoing regulatory monitoring is vital to ensure continued compliance, safety, and efficacy of pharmaceutical products.

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FAQs

1. What are the primary regulations governing oxytocin API manufacturing?
GMP compliance, adherence to pharmacopoeial standards (USP, EP, JP), and regulatory approvals from authorities such as FDA, EMA, and other regional bodies regulate oxytocin API manufacturing.

2. Can regional manufacturers supply APIs that meet international quality standards?
Yes. Many Asian manufacturers have achieved cGMP certification and meet international standards, making them viable sources when validated adequately.

3. How do I verify the quality of an oxytocin API batch?
Request detailed Certificates of Analysis, perform independent analytical testing if possible, and confirm compliance with pharmacopoeial specifications for purity, potency, endotoxin, and microbial limits.

4. What risks are associated with sourcing oxytocin API from emerging markets?
Risks include variable quality control, regulatory non-compliance, supply instability, and documentation issues. Rigorous qualifications and audits mitigate these risks.

5. Is it feasible for small-scale compounding pharmacies to procure bulk API directly?
While possible, it is often complex due to regulatory requirements; partnering with authorized distributors or GMP-compliant suppliers is generally recommended for compliance assurance.

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References

[1] United States Pharmacopeia (USP) Monograph on Oxytocin.
[2] USP-NF, Official USP Monograph, 42nd Edition.