Suppliers and packagers for generic pharmaceutical drug: OCTREOTIDE ACETATE

OCTREOTIDE ACETATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232	NDA	Chiesi USA, Inc.	10122-550-28	4 BLISTER PACK in 1 DOSE PACK (10122-550-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	2020-07-06
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232	NDA	Amryt Pharmaceuticals Designated Activity Company	69880-120-28	4 BLISTER PACK in 1 DOSE PACK (69880-120-28) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK	2020-07-06
Fresenius Kabi Usa	OCTREOTIDE ACETATE	octreotide acetate	INJECTABLE;INJECTION	077450	ANDA	Fresenius Kabi USA, LLC	63323-378-05	1 VIAL, MULTI-DOSE in 1 CARTON (63323-378-05) / 5 mL in 1 VIAL, MULTI-DOSE	2006-03-14

Suppliers for the Pharmaceutical Drug: Octreotide Acetate

Last updated: July 28, 2025

Introduction

Octreotide acetate is a synthetic analog of the natural hormone somatostatin, primarily utilized in the management of acromegaly, neuroendocrine tumors, and certain hormone-secreting tumors. Its ability to inhibit excessive hormone secretion makes it invaluable in clinical settings. The global distribution and sourcing of octreotide acetate involve a complex network of pharmaceutical manufacturers, wholesalers, and authorized distributors, each subject to stringent regulatory standards. For healthcare providers, pharmaceutical companies, and investors, understanding the key suppliers of octreotide acetate is critical for ensuring supply chain stability, compliance, and market analysis.

Manufacturers and Authorized Suppliers of Octreotide Acetate

1. Novartis AG (Sandoz)

Novartis, through its generics division Sandoz, is a leading global supplier of octreotide acetate. The company manufactures both branded and generic formulations, including depot and oral formulations. Novartis maintains a robust global manufacturing footprint with facilities compliant with Good Manufacturing Practices (GMP), ensuring high-quality standards. Their products are approved in multiple jurisdictions, including the United States (FDA approval), the European Union (EMA approval), and other markets (1).

2. Sun Pharmaceutical Industries Ltd.

Sun Pharma is among the prominent Indian-based pharmaceutical manufacturers producing octreotide acetate. The company offers generic formulations, often at lower price points, making them a preferred supplier in emerging markets. Their manufacturing plants are inspected and approved by global regulators, and their products are distributed worldwide, often through authorized distribution networks (2).

3. Teva Pharmaceutical Industries Ltd.

Teva is a significant player in the generic medicine market. Although Teva's primary focus has been on a variety of therapeutic categories, they also supply octreotide acetate, either directly or via licensing agreements. Their extensive distribution network and compliance with international regulatory standards position them as a reliable source (3).

4. Fresenius Kabi

Fresenius Kabi specializes in hospital and infusion therapies, offering octreotide acetate in various formulations suited for clinical use. The company’s manufacturing sites are GMP-certified, and their supply chain focuses on sterile, injectable products that adhere to stringent regulatory standards (4).

5. Other Notable Suppliers

• MediGene AG: Focused on specialty and injectable products, with supply chains reaching European markets.
• Eli Lilly and Company: Has historically been involved in somatostatin analogues, though their role in octreotide acetate supply is more limited.

Regulatory Approvals and Market Availability

Manufacturers must secure approval from agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regional regulators. Approval ensures compliance with manufacturing quality standards and facilitates international distribution.

Distribution Channels and Market Dynamics

Authorized Distributors and Wholesalers

Authorized distributors act as key intermediaries, ensuring compliant and traceable supply chains. Major pharmaceutical wholesalers, such as McKesson, Cardinal Health, and Alliance Healthcare, stock octreotide acetate to serve hospitals, clinics, and specialty pharmacies globally.

Supply Chain Considerations

Supply stability is crucial given octreotide's role in life-threatening conditions. Disruptions can arise from manufacturing issues, regulatory delays, or geopolitical factors. Companies often maintain strategic stockpiles and multiple sourcing arrangements to mitigate risks.

Pricing and Regional Availability

The pricing of octreotide acetate varies widely, influenced by patent statuses, manufacturing costs, and procurement policies. Patented formulations like Sandostatin® (by Novartis) generally command premium pricing, whereas generics are priced more competitively, affecting regional supplier choices.

Emerging Suppliers and Market Trends

Biosimilars and Next-Generation Analogues

The global pharmaceutical industry is witnessing a shift towards biosimilars and next-generation somatostatin analogs, potentially impacting the octreotide acetate supplier landscape. Companies like Mumua Bio and others are developing biosimilar versions, which could alter market dynamics and supplier competition.

Regulatory and Patent Landscape

Patent expirations, notably Sandostatin's patent expiry in many markets, have spurred increased generic manufacturing. Regulatory pathways for biosimilars are evolving, offering new entrants opportunities but also imposing compliance challenges.

Supply Chain Transparency and Import Regulations

Regional import regulations, intellectual property enforcement, and incentives for domestic manufacturing influence supply availability. Companies investing in local manufacturing facilities in emerging markets bolster supply stability.

Key Considerations for Stakeholders

• Regulatory Compliance: Ensure suppliers meet local and international GMP standards.
• Supply Chain Resilience: Diversify sources and maintain strategic inventories.
• Cost Efficiency: Balance quality with affordability, especially in price-sensitive markets.
• Market Access & Licensing: Be aware of licensing agreements and regional approvals affecting availability.
• Future Market Developments: Monitor biosimilar entrants and patent status updates for strategic planning.

Conclusion

The supply landscape for octreotide acetate is characterized by a limited but competitive group of manufacturers, including Novartis (Sandoz), Sun Pharma, Teva, and Fresenius Kabi. These entities operate under rigorous regulatory standards, ensuring high-quality production and global availability. Market trends, patent expirations, and biosimilar development are poised to reshape the supply chain, offering opportunities and challenges for healthcare providers and investors. A strategic approach—emphasizing regulatory compliance, supply diversification, and cost management—is essential for securing reliable access to this critical therapeutic agent.

Key Takeaways

• The dominant suppliers of octreotide acetate include Novartis (Sandoz), Sun Pharma, Teva, and Fresenius Kabi.
• Regulatory approvals from agencies such as the FDA and EMA are vital for international market access.
• The global supply chain relies on authorized distributors and wholesalers to maintain quality assurance.
• Market dynamics are shifting toward biosimilars, which may influence future supplier competition and pricing.
• Ensuring supply chain resilience through diversification and compliance is critical for healthcare stakeholders.

Frequently Asked Questions (FAQs)

1. Are generic versions of octreotide acetate as effective as the branded formulations?
Yes. Generic formulations are required to meet the same regulatory standards and demonstrating bioequivalence, ensuring comparable efficacy and safety to branded versions like Sandostatin®.

2. Which regulators oversee the manufacturing and approval of octreotide acetate globally?
Major regulators include the U.S. FDA, EMA in Europe, and national agencies in other regions. They ensure manufacturing compliance and approve both branded and generic products.

3. How does patent expiration impact the supply and pricing of octreotide acetate?
Patent expirations typically lead to increased manufacturing of generics, improving supply availability and reducing prices, but also intensifying competition among suppliers.

4. Are biosimilars of octreotide acetate available?
While biosimilars are under development, their approval varies by region. Biosimilars could offer more affordable options in the future, contingent on regulatory approvals.

5. What risks should healthcare providers consider when sourcing octreotide acetate?
Risks include supply disruptions, regulatory non-compliance, counterfeit products, and price volatility. Diversifying suppliers and verifying regulatory approvals help mitigate these risks.

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Sources

1. Novartis AG. "Sandostatin (octreotide) Summary of Product Characteristics," EMA, 2022.
2. Sun Pharmaceutical Industries Ltd. Official website, 2023.
3. Teva Pharmaceutical Industries Ltd. Annual Reports, 2022.
4. Fresenius Kabi. "Product Portfolio," 2023.