Bulk Pharmaceutical API Sources for OCTREOTIDE ACETATE (PRESERVATIVE FREE)

Bulk Pharmaceutical API Sources for OCTREOTIDE ACETATE (PRESERVATIVE FREE)

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		6917964
ABI Chem		AC1OCEUW
MolPort		MolPort-006-069-387
AbaChemScene		CS-0944
MedChemexpress MCE		HY-17365
Alsachim		3553

Bulk Active Pharmaceutical Ingredient (API) Sources for: OCTREOTIDE ACETATE (PRESERVATIVE FREE)

Last updated: August 4, 2025

Introduction

Octreotide acetate, a synthetic analog of somatostatin, is a critical peptide hormone used predominantly in the management of endocrine disorders, including acromegaly, carcinoid tumors, and severe diarrhea associated with VIPomas. As a peptide-based API, sourcing high-quality, preservative-free octreotide acetate is vital for pharmaceutical manufacturing, ensuring safety, efficacy, and compliance with regulatory standards. This article delves into the global API suppliers specializing in preservative-free octreotide acetate, analyzing factors influencing procurement, and highlighting the key players in this niche market.

Overview of Octreotide Acetate as an API

Octreotide acetate, identified by its chemical name and CAS number 83199-70-0, is a synthetic octapeptide with a molecular weight of approximately 1019.3 g/mol (free base form). Its formulation in pharmaceutical products requires strict control of purity, stability, and absence of preservatives, especially when intended for parenteral administration. Preservative-free formulations mitigate risks of hypersensitivity and adverse reactions, an essential consideration for chronic therapy.

Manufacturers of preservative-free octreotide acetate supply the peptide primarily in lyophilized or sterile solution forms, tailored to meet pharmaceutical specifications. The complexity of peptide synthesis and purification demands high expertise and advanced manufacturing facilities, often located within regulated environments compliant with cGMP (current Good Manufacturing Practice) standards.

Key Global Suppliers of Preservative-Free Octreotide Acetate API

1. Novartis Pharmaceuticals

Overview:
Novartis, the originator of octreotide, markets Sandostatin®—a formulation of octreotide for clinical use. While primarily a pharmaceutical manufacturer, Novartis also produces bulk API for licensed pharmaceutical partners.

API Supply Capabilities:

• Demonstrates robust capacity for high-purity, preservative-free octreotide acetate.
• Maintains cGMP compliance across manufacturing facilities globally.
• Offers APIs tailored to specific formulation needs, including preservative-free vials.

Market Position:
Novartis’s longstanding expertise in peptide synthesis and global quality standards make it a primary supplier, particularly for large-scale pharmaceutical companies.

2. Zhejiang Medicine Co., Ltd. (Zhejiang Hisun Pharmaceutical Co., Ltd.)

Overview:
A leading Chinese biopharmaceutical and peptide API manufacturer, Zhejiang Medicine specializes in synthetic peptides, including octreotide acetate.

API Production:

• Provides preservative-free octreotide acetate API adhering to international quality norms.
• Utilizes proprietary synthetic methods ensuring high purity and stability.
• Emphasizes cGMP-compliant manufacturing, facilitating export to regulated markets.

Relevance:
Zhejiang Medicine has increasingly gained recognition in the global peptide API space, supported by competitive pricing and scalable manufacturing.

3. Swiss Pharmaceutical Corporation (SPC) Group

Overview:
SPC is a reputable contract manufacturing organization (CMO) with expertise in peptide APIs, including preservatives-free octreotide acetate.

API Capabilities:

• Offers custom synthesis and bulk API supply with strict control over endotoxin levels and purity.
• Ensures API is produced under cGMP standards suitable for licensed pharmaceutical products.

Positioning:
Their focus on quality and manufacturing finesse makes them a preferred partner for pharmaceutical companies seeking reliable supply chains.

4. Bachem AG

Overview:
A Swiss biotech company specializing in peptide synthesis, Bachem supplies high-quality APIs including octreotide acetate.

API Supply Details:

• Provides preservative-free octreotide acetate API with upward of 98% purity.
• Leverages proprietary peptide synthesis technologies to ensure batch consistency.

Market Focus:
Primarily serves biotech and pharma clients requiring custom peptide APIs with stringent quality assurance.

5. Authorized Distributors and Regional Manufacturers in India and Eastern Europe

Overview:
Numerous regional manufacturers and authorized distributors in India, Eastern Europe, and Southeast Asia supply preservative-free octreotide acetate APIs.

Key Features:

• Cost-competitive options tailored to emerging markets.
• Often follow WHO, ICH, and local good manufacturing practice guidelines.
• Supply routes often include export to North American and European markets following regulatory approval.

Examples:
Companies such as Indian Peptides Pvt Ltd. and MedChem Express procure from regional producers with validated manufacturing processes.

Factors Influencing API Source Selection

Regulatory Compliance and Quality Assurance

Ensuring the API supplier adheres to cGMP standards is crucial. Regulatory agencies like the FDA, EMA, and PMDA require manufacturers to demonstrate consistent quality, purity, and stability. Suppliers with certifications, comprehensive quality documentation, and robust supply chain controls are preferred.

Manufacturing Capacity and Scalability

Peptide APIs like octreotide acetate demand sophisticated synthesis, purification, and lyophilization processes. Suppliers with scalable manufacturing capabilities can meet both clinical trial and commercial demand.

Purity, Stability, and Absence of Preservatives

Preservative-free API necessitates meticulous control over endotoxin levels, residual solvents, and other impurities. Suppliers must provide extensive analytical data confirming compliance with pharmacopeial standards.

Pricing and Lead Times

Cost considerations significantly impact sourcing decisions, particularly for regional manufacturers or emerging markets. Lead times depend on synthesis complexity and regulatory clearance, making established suppliers with reliable logistics advantageous.

Supply Chain Security and Regulatory Support

Establishing contracts with suppliers experienced in global distribution and regulatory submissions reduces risk of supply interruptions. Suppliers with proven track records in international markets streamline the approval process for imported APIs.

Market Outlook and Trends

The demand for preservative-free octreotide acetate continues to grow, driven by increasing incidences of acromegaly and neuroendocrine tumors. The trend toward safer, preservative-free formulations influences API sourcing strategies, with major pharmaceutical companies favoring established players with cGMP-compliant facilities. Additionally, the rise of regional manufacturing hubs introduces more competitive options, albeit with rigorous validation requirements.

Global regulatory bodies continue to tighten standards on peptide APIs, emphasizing purity and traceability. Suppliers investing in advanced synthesis technologies and comprehensive quality programs will maintain competitive advantages. The COVID-19 pandemic has underscored the importance of supply chain diversification, prompting pharmaceutical companies to establish multiple sourcing channels for critical APIs like octreotide acetate.

Key Considerations for Buyers

• Assess supplier certifications: Look for cGMP compliance, ISO standards, and regulatory approvals.
• Review analytical and quality data: Prioritize suppliers with comprehensive testing reports verifying API purity, endotoxin levels, and residual solvents.
• Evaluate manufacturing capacity: Confirm scalability for both clinical and commercial needs.
• Ensure supply chain reliability: Work with suppliers experienced in international logistics and regulatory navigation.
• Negotiate pricing and lead times: Balance cost with quality and delivery flexibility.

Conclusion

Sourcing preservative-free octreotide acetate API requires careful evaluation of supplier capability, quality assurance practices, regulatory compliance, and capacity. Leading global players like Novartis and specialized peptide manufacturers such as Bachem AG and SPC Group offer high-purity, cGMP-certified APIs suitable for pharmaceutical production. Regional manufacturers in Asia and Eastern Europe provide cost-effective alternatives, but require thorough validation. Navigating this market hinges on aligning quality, compliance, and supply chain robustness to ensure uninterrupted, safe, and effective therapeutic formulations.

---

Key Takeaways

• Preservative-free octreotide acetate APIs are sourced predominantly from established global pharma companies, specialized peptide manufacturers, and regional producers.
• Regulatory compliance, API purity, manufacturing scalability, and supply chain reliability are critical factors influencing procurement decisions.
• Leading suppliers like Novartis, Bachem, SPC Group, and Zhejiang Medicine are recognized for high-quality APIs meeting international standards.
• The market trend leans toward increased demand for preservative-free peptide APIs, emphasizing purity and safety.
• Diversification of sourcing strategies can mitigate supply risks amid global supply chain disruptions.

---

FAQs

1. What are the primary factors to consider when sourcing preservative-free octreotide acetate API?
Key factors include regulatory compliance (cGMP standards), API purity and stability, manufacturing capacity, supply chain reliability, and cost.

2. Are regional manufacturers suitable for pharmaceutical-grade octreotide acetate?
Yes, provided they follow stringent quality control, adhere to international standards (e.g., ICH, GMP), and have documented regulatory approvals.

3. How does preservative-free octreotide acetate API differ from formulations containing preservatives?
Preservative-free APIs are produced without added preservatives, reducing hypersensitivity risks. They are strictly purified, endotoxin-controlled, and intended for parenteral formulations requiring high safety profiles.

4. What regulations impact the import and use of octreotide acetate API?
Regulations include cGMP compliance, pharmacopeial quality standards (e.g., USP, EP, BP), and country-specific import licenses. Regulatory agencies like FDA, EMA, and PMDA enforce these standards.

5. How can companies ensure a stable supply of preservative-free octreotide acetate?
By establishing relationships with multiple verified suppliers, maintaining inventory buffers, and verifying the supplier’s supply chain resilience and compliance history.

---

References

[1] Novartis Pharmaceuticals. Sandostatin® Product Information.
[2] Zhejiang Hisun Pharmaceutical Co., Ltd. Official Website.
[3] Swiss Pharmaceutical Corporation (SPC) Group. Peptide API Manufacturing Capabilities.
[4] Bachem AG. Peptide API Portfolio.
[5] International Conference on Harmonisation (ICH) Guidelines. Quality Standards for Peptide APIs.