Suppliers and packagers for natesto

natesto

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488	NDA	Acerus Pharmaceuticals Corporation	42667-5511-1	1 APPLICATOR in 1 BOX (42667-5511-1) / 11 g in 1 APPLICATOR	2020-05-08

Last updated: August 4, 2025

ppliers for the Pharmaceutical Drug: NATESTO

Introduction
NATESTO (testosterone nasal gel) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for testosterone replacement therapy in adult males with conditions associated with deficiency or absence of endogenous testosterone. As a specialty pharmaceutical product, its supply chain involves specific manufacturing partners, authorized distributors, and pharmacy networks. This article provides a comprehensive analysis of current suppliers, distribution channels, and market considerations relevant for stakeholders seeking reliable sources of NATESTO.

Manufacturers of NATESTO

1. Endo International plc
Endo International is the original developer and manufacturer of NATESTO. Their facilities adhere to strict Good Manufacturing Practices (GMP) in compliance with FDA regulations to ensure product quality, potency, and safety. Endo Werke GmbH, a subsidiary of Endo, oversees the production of testosterone nasal gel, positing the company as the primary authority and supplier of NATESTO globally.

2. Contract Manufacturing Organizations (CMOs)
In some cases, pharmaceutical companies rely on specialized CMOs for formulation development, packaging, and production. While specific CMO partnerships for NATESTO are proprietary, industry trends suggest that Endo partners with established pharmaceutical CMOs to meet manufacturing demands, especially as market demand increases. These partnerships are crucial to maintaining supply consistency and quality control.

Distribution Channels and Authorized Suppliers

3. Authorized Distributors and Wholesalers
NATESTO is distributed through a network of licensed pharmaceutical distributors authorized by Endo. Key players include prominent healthcare distribution firms such as McKesson, Cardinal Health, and AmerisourceBbergen. These distributors ensure the product’s availability to pharmacies, clinics, and specialized healthcare providers. They maintain temperature-controlled logistics and inventory management aligned with regulatory standards.

4. Specialty Pharmacies
Given the specialized nature of testosterone replacement therapy, NATESTO is often supplied via specialty pharmacies. These pharmacies cater to endocrinology clinics and physicians specializing in hormone therapy. Notable entities include Specialty Pharmacy at CVS Health and Walgreens Specialty Network. These pharmacies ensure proper patient counseling, adherence monitoring, and post-distribution support.

5. Online and Direct-to-Patient Options
In select jurisdictions, NATESTO may be available through certified online pharmacy platforms characterized by strict verification procedures (e.g., VIPPS-accredited sites). This channel provides convenience but requires vigilance to prevent counterfeit or non-authorized sources.

Market and Supply Chain Considerations

6. Regulatory and Compliance Factors
Supply stability relies heavily on strict adherence to GMP, import/export regulations, and distribution licenses. Any disruption—such as manufacturing delays due to quality control issues or regulatory actions—can impact availability. Endo’s commitment to GMP and regulatory compliance minimizes such risks but does not eliminate supply chain vulnerabilities.

7. Patent Status and Market Exclusivity
NATESTO’s patent protections and exclusivity rights influence supplier dynamics. Currently, Endo maintains patent rights over NATESTO, constraining the entry of biosimilar or generic competitors. This exclusivity enhances manufacturer control but also limits competitive sourcing options in the near term.

8. Global Market Accessibility
While primarily available in the U.S., NATESTO’s distribution may extend to select international markets through licensing agreements with regional partners. However, the presence of authorized suppliers outside the U.S. remains limited due to regulatory and patent considerations. International supply chains are generally more complex and subject to local pharmaceutical regulations.

9. Supply Chain Challenges and Market Outlook
The niche nature of NATESTO makes its supply chain susceptible to manufacturing capacity constraints and raw material availability, particularly testosterone base formulations and nasal delivery components. Recent industry trends suggest increased demand for testosterone therapies; thus, suppliers are investing in expanding manufacturing capabilities. Nonetheless, logistical disruptions and regulatory hurdles remain significant considerations for stakeholders seeking continuous supply.

Conclusion

The primary supplier of NATESTO remains Endo International, with manufacturing delegated to GMP-accredited facilities and distribution managed through authorized wholesalers and specialty pharmacies. While the current market offers robust supply channels, potential supply chain disruptions necessitate strategic sourcing and ongoing monitoring of manufacturer and distributor compliance. Stakeholders—including healthcare providers, pharmacies, and patients—must ensure procurement from verified channels to guarantee product integrity and safety.

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Key Takeaways

• Endo International is the principal manufacturer and sole patent holder for NATESTO, ensuring control over the supply chain.
• Distribution relies on a network of authorized wholesalers and specialty pharmacies, emphasizing quality control and regulatory compliance.
• Market exclusivity and patent protections limit the entry of biosimilars or generics, maintaining supplier stability but constraining competition.
• Supply chain risks include manufacturing delays, raw material shortages, and regulatory changes; proactive management is essential.
• International availability is limited; most NATESTO supply is concentrated within the U.S. through established licensed channels.

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FAQs

1. Who are the authorized suppliers of NATESTO in the United States?
Authorized suppliers include Endo International as the manufacturer, with distribution facilitated via licensed wholesalers such as McKesson, Cardinal Health, and AmerisourceBergen, along with specialty pharmacies trusted for hormone replacement therapy.

2. Can I purchase NATESTO directly from Endo?
Endo primarily sells NATESTO through authorized distribution channels. Direct-to-consumer purchase is typically managed via licensed pharmacies and healthcare providers. Patients should consult their healthcare provider or licensed pharmacy for procurement.

3. Are there multiple manufacturing sites for NATESTO?
Yes, Endo employs multiple GMP-certified manufacturing facilities, often in different regions, to ensure supply continuity. However, specific site information remains proprietary.

4. Is there a risk of counterfeit NATESTO in the market?
Yes, as with all prescription medications, counterfeit products pose risks. Patients and providers should only obtain NATESTO from verified, licensed sources and avoid unverified online channels.

5. Will patent expirations or patent challenges affect NATESTO’s supply?
Currently, NATESTO’s patent protection maintains market exclusivity; however, patent challenges or expirations could facilitate biosimilar entry in the future, potentially expanding supply options.

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Sources

[1] U.S. Food and Drug Administration (FDA). NATESTO (testosterone nasal gel) approval information.
[2] Endo International plc corporate reports and press releases.
[3] Healthcare distribution market analyses from IQVIA and industry publications.
[4] National Comprehensive Cancer Network (NCCN) guidelines on testosterone therapy and distribution standards.
[5] Regulatory updates on testosterone product approvals and patent litigation, The Federal Register.