Bulk Pharmaceutical API Sources for OXYTOCIN 10 USP UNITS IN DEXTROSE 5%

Bulk Pharmaceutical API Sources for OXYTOCIN 10 USP UNITS IN DEXTROSE 5%

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		O3251_SIGMA
Sigma-Aldrich		O4375_SIGMA
Sigma-Aldrich		O6379_SIGMA

Bulk Active Pharmaceutical Ingredient (API) Sources for: OXYTOCIN 10 USP UNITS IN DEXTROSE 5%

Last updated: August 8, 2025

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Introduction

Oxytocin, a peptide hormone with critical applications in obstetrics, is marketed as a bulk active pharmaceutical ingredient (API) in various formulations, notably as 10 USP units in dextrose 5%. Its reliable sourcing is paramount for pharmaceutical manufacturing, ensuring product efficacy, safety, and regulatory compliance. This article explores the primary global suppliers of oxytocin API, the considerations in sourcing, and the industry landscape to support business decisions for pharmaceutical manufacturers.

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Overview of Oxytocin API

Oxytocin is a cyclic nonapeptide synthesized through recombinant DNA technology or extraction from animal tissues, with synthetic production predominantly via recombinant methods for purity and consistency. The API's quality attributes — including potency, purity, stability, and compliance with pharmacopeial standards such as USP — dictate the selection of suppliers.

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Global API Suppliers for Oxytocin

1. Jinzhou Pharmaceutical Co., Ltd. (China)

A major manufacturer of peptide APIs, Jinzhou Pharmaceutical is recognized for its robust production of oxytocin. Their facilities adhere to Good Manufacturing Practices (GMP) and are often certified by major regulatory bodies. Jinzhou supplies bulk oxytocin API to international markets and has a well-established reputation for quality compliance with USP standards.

2. Yunnan Keyuen Bio-Technology Co., Ltd. (China)

Specializing in peptide APIs, Yunnan Keyuen offers recombinant oxytocin suitable for pharmaceutical formulations. Their production encompasses rigorous quality control, ensuring conformity to USP monographs. They serve clients across Asia, Europe, and North America, supporting large-scale manufacturing requirements.

3. Ferring Pharmaceuticals (Sweden/Global)

Ferring is a leading global biopharmaceutical company with proprietary production lines for oxytocin API. Their pharmaceutical-grade APIs are produced under stringent GMP conditions and certified for global markets, including compliance with USP standards where applicable.

4. Hybio Pharmaceutical Co., Ltd. (China)

Hybio produces peptide APIs, including oxytocin, with a focus on high purity and stability. Their facilities are GMP-certified, and they export to a broad customer base worldwide, providing customizable API batches to meet specific formulation needs.

5. Peptides International (United States)

A U.S.-based supplier of peptide APIs, Peptides International offers high-quality oxytocin for pharmaceutical use. Their APIs are manufactured following strict quality certifications, and they maintain active dialogues with regulatory authorities to ensure compliance with USP specifications.

6. Boao Pharmaceutical Co., Ltd. (China)

Specializing in peptide pharmaceuticals, Boao provides bulk oxytocin API with rigorous quality control procedures aligned with USP standards. Their focus on research and development ensures continuous improvement in product quality.

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Criteria for Sourcing Oxytocin API

Quality and Compliance:
Manufacturers must verify GMP certification, USP monograph adherence, residual solvent levels, endotoxin limits, and peptide purity. Independent analytical testing or supplier certificates of analysis (COA) are essential in validation.

Regulatory Approvals:
Ensure suppliers possess appropriate regulatory clearances, such as FDA, EMA, or NMPA approvals, particularly if the API will be used in markets with strict regulatory frameworks.

Supply Stability and Capacity:
Assess the supplier's production capacity, lead times, and ability to meet ongoing demand, especially pertinent during global supply chain disruptions.

Pricing and Contract Terms:
Evaluate pricing structures that reflect quality, batch consistency, and quantity commitments. Consider long-term contracts to secure supply continuity.

Technological Capabilities:
Opt for suppliers utilizing recombinant DNA technology for high purity and batch-to-batch consistency, reducing risks of impurities common in extraction from animal tissues.

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Industry Trends and Challenges

Regulatory Scrutiny and Quality Assurance:
Increasing regulatory oversight demands extensive documentation, analytical validation, and strict quality management systems from API suppliers.

Supply Chain Disruptions:
Geopolitical tensions and health emergencies have underscored the importance of diversification and robust supply chain strategies, compelling companies to source from multiple qualified vendors.

Biotechnological Advancements:
Recombinant peptide production offers higher purity and consistency, rising as the standard in API manufacturing for hormones like oxytocin.

Cost Considerations:
While China remains dominant due to lower manufacturing costs, Western companies often prefer GMP-certified suppliers with documented quality systems.

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Conclusion

Securing a reliable bulk source of oxytocin API necessitates a comprehensive evaluation of supplier quality, regulatory compliance, technological capacity, and supply stability. Predominantly, Chinese manufacturers like Jinzhou Pharmaceutical, Yunnan Keyuen, and Hybio lead global supply—offering high-quality recombinant APIs aligned with USP standards. Western firms such as Ferring and Peptides International provide proven quality and regulatory adherence, often preferred for markets with stringent requirements.

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Key Takeaways

• Diversify suppliers to mitigate supply chain risks, emphasizing both Chinese GMP-certified manufacturers and Western specialized providers.
• Prioritize recombinant oxytocin synthesis for superior purity, consistent potency, and regulatory compliance.
• Confirm regulatory certifications and analytical data before engagement to ensure API quality meets USP standards and regional requirements.
• Build strategic relationships with suppliers capable of scalable production and rapid response to demand fluctuations.
• Stay abreast of industry trends in biotechnology and regulatory policies to optimize sourcing strategies and maintain competitive advantage.

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FAQs

1. What are the primary regions for sourcing oxytocin API globally?
China dominates as the primary supplier region due to cost efficiencies and manufacturing capacity, followed by established Western manufacturers in Europe and the U.S. offering high-quality, compliance-certified APIs.

2. How does recombinant oxytocin compare to traditionally extracted forms?
Recombinant oxytocin offers higher purity, consistency, and lower risk of impurities or contaminants, making it the preferred choice for pharmaceutical applications.

3. What regulatory considerations are important when sourcing oxytocin API?
Manufacturers should verify GMP certification, USP compliance, and approval from relevant regulatory authorities (FDA, EMA, NMPA). Documentation like COAs and analytical validation are critical.

4. How does supply chain security impact API sourcing?
Robust supply chain strategies—such as multiple supplier relationships, regional diversification, and inventory management—are essential to minimize disruptions and ensure continuous production.

5. What role do industry trends like biotechnological advances play in API sourcing decisions?
Emerging biotech methods, especially recombinant synthesis, are improving API quality and consistency, influencing procurement strategies towards suppliers utilizing these advanced technologies.

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Sources

1. USP Monograph for Oxytocin. United States Pharmacopeia, 2023.
2. Industry reports on peptide API manufacturing. Global Peptide Market Outlook, 2022.
3. Supplier websites: Jinzhou Pharmaceutical, Yunnan Keyuen, Hybio, Peptides International.
4. Regulatory guidelines: FDA, EMA, NMPA standards for peptide APIs.