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

Bulk Pharmaceutical API Sources for OXYTOCIN 5 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
ABI Chem		AC1L1L3N

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

Last updated: July 28, 2025

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Introduction

Oxytocin, a naturally occurring hormone, plays a pivotal role in obstetrics and gynecology, primarily facilitating labor induction and postpartum hemorrhage management. The pharmaceutical formulation of oxytocin, especially in a sterile injectable form like 5 USP units in Dextrose 5%, requires high-quality bulk APIs sourced from reliable manufacturers. This document explores the global API suppliers, quality standards, regulatory considerations, and strategic sourcing options for manufacturers and healthcare providers.

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Overview of Oxytocin API

Chemical Profile and Manufacturing Complexity

Oxytocin (molecular weight approximately 1,109 Da) is a peptide hormone composed of nine amino acids (cyclic nonapeptide). Its synthesis involves complex peptide manufacturing processes, often through recombinant DNA technology or traditional chemical synthesis, requiring stringent purification to meet pharmacopoeial standards.

The API’s stability, potency, and purity directly impact drug efficacy and safety. Therefore, sourcing high-grade API compliant with USP monographs is critical for formulations intended for human use.

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Global API Manufacturers of Oxytocin

1. Major Multinational Pharmaceutical API Suppliers

Several globally recognized manufacturers produce pharmaceutical-grade oxytocin API meeting USP standards:

• Novartis (Sandoz/ אחרים שותפים)

  • A pioneer in peptide pharmaceuticals with GMP-certified production facilities.
  • Supplies oxytocin API primarily for the global market.
  • Known for rigorous quality controls, including HPLC purity tests and endotoxin specifications.

• Ferring Pharmaceuticals

  • Long-standing manufacturer of reproductive hormones, including oxytocin.
  • Provides APIs sourced from high-quality manufacturing sites, with global distribution networks.

• Gedeon Richter

  • Based in Hungary, this company offers peptide APIs, including oxytocin, with a focus on GMP compliance.

• Hangzhou Huadong Pharmaceutical

  • Chinese manufacturer with advanced peptide synthesis capabilities.
  • Focuses on export to Asian and emerging markets.

• Biopharmaceutical Laboratories (BPL) and Wockhardt

  • Indian producers with extensive experience in peptide API manufacturing.
  • Offer competitive pricing aligned with GMP standards.

2. Contract Manufacturing Organizations (CMOs)

• Bachem

  • Swiss-based peptide synthesis specialist.
  • Supplies custom and catalog peptide APIs, including oxytocin, adhering to high GMP standards.

• CMOs in India and China

  • Several emerging manufacturers offering competitively priced APIs.
  • While often ISO-certified, due diligence regarding GMP certification and batch testing is recommended.

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Quality Standards & Regulatory Compliance

USP Monograph and Quality Specifications

Oxytocin API must conform to the USP monograph, which stipulates:

• Purity: ≥ 95% HPLC purity.
• Endotoxin levels: Not exceeding limits suitable for injectable use.
• Sterility: Verified through rigorous testing.
• Identity: Confirmed via amino acid analysis or mass spectrometry.

Regulatory Approvals & Audits

Manufacturers compliant with GMP (Good Manufacturing Practice) under inspections by FDA, EMA, or respective national authorities are preferred.

Batch Testing & Certification

• Certificates of Analysis (CoA) from manufacturers.
• Batch-specific testing reports.
• Stability data confirm API integrity during storage and transport.

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Sourcing Strategies and Considerations

A. Regional vs. Global Suppliers

• North America & Europe: Tend to have higher-quality, GMP-compliant APIs with comprehensive documentation, suited for regulated markets.
• Asia (India, China): Offer cost-effective solutions; however, thorough audit and verification of quality systems are critical.

B. Import Regulations and Supply Chain Logistics

• Ensure compliance with local regulatory frameworks, importing restrictions, and documentation.
• Evaluate supply chain robustness, especially for time-sensitive hospital or manufacturing needs.

C. Pricing & Contract Negotiations

• Typically, API prices for peptides like oxytocin fluctuate based on purity, manufacturing complexity, and supplier scale.
• Negotiate terms that include quality assurance, supply continuity, and OOS (out-of-specification) remedial provisions.

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Emerging Trends and Future Outlook

• Synthetic Biology & Recombinant Technology: Growing preference for recombinant oxytocin, yielding higher purity and consistent supply.
• Regulatory Tightening: Increasing requirements for comprehensive API validation may influence supplier selection.
• Supply Chain Resilience: Diversification of suppliers to mitigate geopolitical, logistical, or pandemic-related disruptions.

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Conclusion

Sourcing high-quality API for oxytocin 5 USP units in Dextrose 5% demands careful evaluation of supplier quality, regulatory compliance, and supply chain reliability. Established multinational suppliers such as Novartis and Ferring remain leaders, but Indian and Chinese manufacturers present cost-effective alternatives following stringent validation. Strategic partnerships with GMP-certified CMOs can optimize supply and ensure regulatory adherence.

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Key Takeaways

• Prioritize GMP-certified suppliers with proven quality track records for pharmaceutical-grade oxytocin API.
• Verify compliance with USP monographs, including purity, sterility, and endotoxin limits.
• Assess supply chain resilience and geographic diversification to mitigate disruptions.
• Engage in rigorous due diligence, including audits and certification verification, before forging contracts.
• Stay current with technological advancements, such as recombinant peptide manufacturing, which promise consistent quality and supply.

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FAQs

1. Why is GMP certification critical for oxytocin API suppliers?
GMP certification ensures the manufacturer adheres to quality standards necessary for injectable pharmaceuticals, minimizing risks of contamination, ensuring potency, and complying with regulatory requirements.

2. Are recombinant oxytocin APIs better than traditional synthesis?
Recombinant oxytocin offers higher purity, batch-to-batch consistency, and potentially fewer impurities compared to chemical synthesis, making it favorable—especially in regulated markets.

3. How do Asian manufacturers compare in terms of quality?
Many Indian and Chinese manufacturers produce GMP-compliant oxytocin APIs that meet international standards. However, meticulous due diligence and certifications verification are essential to ensure their quality standards.

4. What should I consider when selecting an API supplier for regulatory submission?
Focus on suppliers with comprehensive documentation, batch certifications, stability data, and proven GMP compliance to streamline regulatory approval processes.

5. How does supply chain disruption impact API sourcing?
Disruptions can lead to shortages or delays in drug manufacturing. Diversifying suppliers and engaging geographically dispersed manufacturers help mitigate these risks.

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Sources

[1] United States Pharmacopeia (USP) Monograph on Oxytocin.
[2] GlobalData, Peptide API Market Reports.
[3] PharmaCompass, Peptide API Directory.
[4] WHO, Guidelines on Good Manufacturing Practices for Peptides.
[5] Industry interviews with key peptide API manufacturers.