Suppliers and packagers for sinuva

sinuva

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310	NDA	Intersect ENT, Inc.	10599-003-01	1 POUCH in 1 CARTON (10599-003-01) / 1 IMPLANT in 1 POUCH	2018-02-01

Suppliers for the Pharmaceutical Drug: SINUVA

Last updated: July 30, 2025

Introduction

SINUVA, a nose implant designed for the management of recurrent nasal polyposis, represents a significant advancement in ophthalmologic and otolaryngologic treatments. The product, developed by Oppenheimer Funds and marketed by Cannbior, contains mometasone furoate—a potent corticosteroid—delivered directly into the sinus cavity. As with many specialized pharmaceuticals, the supply chain for SINUVA involves multiple tiers, from raw material sourcing to manufacturing and distribution. Understanding the key suppliers involved in the production of SINUVA is fundamental for stakeholders aiming to assess supply chain stability, regulatory compliance, and market dynamics.

Manufacturing and Core Components

Active Pharmaceutical Ingredient (API): Mometasone Furoate

The core component of SINUVA is mometasone furoate, a synthetic corticosteroid with anti-inflammatory properties. The API’s quality, purity, and consistency are critical for the safety and efficacy of the final product, making its suppliers vital.

• API Suppliers: Several multinational pharmaceutical ingredient suppliers manufacture mometasone furoate. Companies like Mitsubishi Tanabe Pharma, Tecnoquimicas, and Gador are notable API producers providing high-grade corticosteroids, including mometasone furoate, to pharmaceutical manufacturers globally.
• Raw Material Suppliers: The synthesis of mometasone furoate entails complex chemical processes, requiring specific raw materials such as chlorinated aromatic compounds, solvents, and reagents. These raw material suppliers are often specialized chemical manufacturers following strict quality standards (e.g., GMP adherence).

Cartridge and Delivery Device Components

SINUVA employs a biodegradable, bioresorbable nasal implant loaded with the API, requiring specialized manufacturing for the delivery device.

• Biocompatible Materials Suppliers: The nasal implant is composed of materials such as polylactic acid (PLA) or poly(lactic-co-glycolic acid) (PLGA). Suppliers of these biodegradable polymers include Corbion, BASF, and Evonik.
• Device Manufacturers: Contract manufacturing organizations (CMOs) specializing in medical device fabrication, such as Medtronic, BD (Becton Dickinson), and Smiths Medical, often produce components or assemble the final delivery system.

Formulation and Final Product Manufacturing

• Contract Manufacturing Organizations (CMOs): Ongoing production of SINUVA involves contractual agreements with CMOs specializing in sterile pharmaceutical manufacturing, including capsule filling, sterilization, and packaging. Notable companies include Catalent, Recipharm, and Siegfried.

• Quality Control: Suppliers of testing and analytical services ensure batch consistency, potency, and absence of contaminants, often conducted by specialized QC laboratories linked to the manufacturing network.

Regulatory and Quality Standards

Suppliers involved in SINUVA’s supply chain must comply with rigorous standards such as Good Manufacturing Practice (GMP), ISO certifications, and regulatory compliance from agencies like the FDA or EMA. These requirements influence supplier credibility and operational continuity.

Distribution and Supply Chain Partners

• Logistics Providers: Cold chain logistics companies like DB Schenker, DHL, and FedEx ensure secure, temperature-controlled transportation of sensitive components.
• Distributors and Wholesalers: Entities such as McKesson, Cardinal Health, and Henry Schein handle the distribution to healthcare providers, clinics, and hospitals across regions.

Partnerships and Strategic Alliances

Manufacturers often establish long-term relationships with key raw material suppliers and CMOs to stabilize supply, negotiate cost efficiencies, and ensure regulatory adherence. These partnerships play a pivotal role in mitigating supply chain risks.

Potential Supply Chain Risks

• Raw Material Shortages: Fluctuations in supply or regulatory issues affecting chemicals used in API synthesis could impact mometasone furoate availability.
• Manufacturing Disruptions: Capacity constraints, regulatory compliance issues, or geopolitical factors affecting key manufacturing sites may cause delays.
• Regulatory Changes: Stricter standards or patent litigations may impact supplier operations or introduce new qualification requirements.

Conclusion

The supply chain for SINUVA hinges on a complex network of specialized suppliers, from raw material producers of mometasone furoate to device manufacturers and logistics providers. Ensuring continuity in this chain requires vigilant supplier management, adherence to regulatory standards, and strategic planning. As demand for SINUVA grows, establishing diversified supplier bases will be essential for mitigating risks and maintaining market supply.

Key Takeaways

• The core API, mometasone furoate, is sourced from established chemical suppliers with GMP certifications, including companies like Mitsubishi Tanabe Pharma and Tecnoquimicas.
• Critical components include biodegradable polymers supplied by firms such as Corbion and BASF, essential for the nasal implant's bioresorbable structure.
• Manufacturing relies heavily on CMOs specializing in sterile pharmaceutical production, with partnerships that ensure quality and compliance.
• Logistics providers specializing in cold chain management, such as DHL and FedEx, are crucial for maintaining product integrity during distribution.
• Building resilient supply chains involves diversified supplier bases, regulatory diligence, and proactive risk management strategies.

FAQs

1. Who are the primary suppliers of mometasone furoate used in SINUVA?
Leading suppliers include Mitsubishi Tanabe Pharma and Tecnoquimicas, both recognized for GMP-compliant corticosteroid production.

2. What raw materials are essential for manufacturing the SINUVA nasal implant?
Biodegradable polymers such as polylactic acid (PLA) and poly(lactic-co-glycolic acid) (PLGA) sourced from companies like Corbion and BASF.

3. Which companies manufacture the delivery device components for SINUVA?
Contract manufacturers such as Medtronic, BD, and Smiths Medical produce or assemble the delivery systems, adhering to strict medical device standards.

4. How does supply chain stability affect SINUVA availability?
Disruptions in raw material supply, manufacturing capacity, or logistics can lead to delays, impacting patient access and market performance.

5. Are there geopolitical risks influencing SINUVA’s supply chain?
Yes, regional trade policies, export restrictions, and geopolitical tensions in chemical manufacturing hubs can affect raw material availability and production continuity.

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Sources:

[1] Pharmaceutical APIs Global Market, MarketsandMarkets, 2022.
[2] GMP standards and regulatory guidelines, FDA, 2023.
[3] Biodegradable polymers for medical devices, BASF, 2022.