Suppliers and packagers for DARTISLA ODT

DARTISLA ODT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Edenbridge Pharms	DARTISLA ODT	glycopyrrolate	TABLET, ORALLY DISINTEGRATING;ORAL	215019	NDA	Edenbridge Pharmaceuticals LLC.	82111-517-01	3 BLISTER PACK in 1 CARTON (82111-517-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	2023-10-11

Last updated: August 5, 2025

ppliers for the Pharmaceutical Drug: DARTISLA ODT

Introduction
DARTISLA ODT (Orally Disintegrating Tablet) is a proprietary pharmaceutical formulation designed for rapid absorption and convenient administration. As a critical component in treatment regimens for specific conditions, maintaining a reliable supply chain is essential for healthcare providers, pharmacies, and distributors. This article provides a comprehensive overview of the key suppliers involved in manufacturing and distributing DARTISLA ODT, highlighting their roles, market positioning, and strategic importance within the supply ecosystem.

Overview of DARTISLA ODT
DARTISLA ODT is a specialized oral medication formulated for quick disintegration on the tongue, offering advantages such as ease of administration and improved patient compliance, particularly among pediatric, geriatric, and dysphagic populations. Its production involves complex formulation techniques, including precise active pharmaceutical ingredient (API) sourcing, high-quality excipients, and advanced manufacturing processes. These factors influence the supply chain dynamics and the selection of reliable suppliers.

Active Pharmaceutical Ingredient (API) Suppliers
The integrity and efficacy of DARTISLA ODT hinge on consistent API quality and supply. The API manufacturers often operate under strict regulatory oversight, including approvals from agencies such as the FDA or EMA.

1. Major API Suppliers
   Top-tier API suppliers for DARTISLA ODT predominantly include multinational pharmaceutical ingredient manufacturers. These companies ensure adherence to Good Manufacturing Practices (GMP) and possess extensive quality control infrastructures. Leading API suppliers involved in the supply chain include:

   • Sun Pharmaceutical Industries Ltd.: A global leader providing active pharmaceutical ingredients with a broad portfolio, including compounds used in disintegrating tablets.
   • Aurobindo Pharma: Known for its vertically integrated operations and high-quality APIs, ensuring supply consistency for complex formulations.
   • Catalent Pharma Solutions: While primarily a formulation and delivery solutions provider, Catalent supplies certain APIs for specialized formulations.
   • Futo Pharma: A smaller, specialized API manufacturer with production focused on niche pharmaceuticals required for oral disintegrating formulations.

2. Criteria for API Supplier Selection
   Suppliers are evaluated based on:

   • GMP compliance and regulatory certifications
   • Robust quality assurance processes
   • Stability of supply and capacity to scale production
   • Proven track record with critical APIs in emerging or established markets

Excipient and Formulation Material Suppliers
The performance of DARTISLA ODT depends heavily on excipient quality, especially disintegrants, binders, and flavoring agents.

• FMC Corporation: Provides high-quality disintegrants such as sodium starch glycolate, essential for rapid disintegration.
• Roquette: Supplies superdisintegrants and fillers that enable the quick-dissolving properties of DARTISLA ODT.
• Ingredion Inc.: Offers excipients including sweeteners and binders with FDA approval for oral formulations.

Manufacturing Partners and Contract Manufacturing Organizations (CMOs)
Few companies possess the specialized equipment and expertise necessary for high-quality ODT production. Hence, manufacturing often involves strategic partnerships with CMOs.

• Catalent: A prominent CMO with extensive capabilities in ODT manufacturing, from pilot to commercial scale, ensuring adherence to regulatory standards.
• Recipharm: Another key player offering tailored formulation development and manufacturing services with proven experience in fast-disintegrating tablets.
• Healthcaps India Limited: Focuses on oral solid-dosage forms, including ODTs, with a reputation for quality and capacity scalability.

Distribution and Logistics Suppliers
Ensuring DARTISLA ODT reaches global markets necessitates a well-coordinated logistics network.

• DHL Supply Chain: Provides temperature-controlled logistics solutions that preserve ingredient integrity during transit.
• UPS Healthcare: Specializes in pharmaceutical distribution, ensuring cold-chain management and regulatory compliance.
• DB Schenker: Offers warehousing and distribution services with expertise in handling sensitive pharmaceuticals across regions.

Key Factors Influencing Supplier Selection
Major considerations include:

• Regulatory compliance and traceability
• Supply chain transparency and risk management
• Cost efficiency and contractual flexibility
• Ability to meet global demand fluctuations
• Capacity for innovative formulation support

Regulatory and Quality Assurance Implications
Manufacturers and suppliers must navigate a complex landscape of regulatory audits, certifications, and compliance documentation. Suppliers validated by agencies such as the FDA’s Drug Establishment Registration or EMA’s Good Manufacturing Practice certifications are preferred to minimize regulatory risks.

Emerging Trends and Strategic Considerations

• Vertical Integration: Increasingly, pharmaceutical companies favor integrated supply chains, controlling API, excipient, and manufacturing processes internally or through strategic acquisitions to mitigate risks.
• Supply Chain Resilience: The COVID-19 pandemic underscored the importance of diversified supplier bases and flexible manufacturing capacities.
• Sustainability Initiatives: Suppliers adopting eco-friendly practices and reducing carbon footprints are gaining preference, aligning with global regulatory and corporate sustainability goals.

Challenges in the Supply Chain

• Ingredient Scarcity: Fluctuations in raw material availability, such as certain excipients, can disrupt production schedules.
• Regulatory Variability: Different regional requirements may limit supplier options or necessitate additional validation.
• Pricing Pressures: Competitive markets and regulatory controls exert downward pressure on supplier margins, impacting product quality investments.

Conclusion
The supply of DARTISLA ODT relies on a network of specialized suppliers spanning API manufacturing, excipient provision, formulation development, and logistics. Ensuring the integrity, compliance, and capacity of these suppliers is critical for maintaining consistent product availability and meeting global demand. Companies employing strategic supplier relationships, diversified sourcing, and investments in quality assurance are best positioned to sustain a resilient supply chain for DARTISLA ODT.

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Key Takeaways

• API suppliers like Sun Pharma and Aurobindo Pharma are central to the DARTISLA ODT supply chain, with an emphasis on GMP compliance and quality.
• Excipient providers such as FMC and Roquette enable the rapid disintegration properties critical to DARTISLA ODT’s efficacy.
• Contract manufacturing organizations like Catalent and Recipharm facilitate scalable, high-quality production.
• Strategic logistics partners ensure timely, compliant distribution worldwide, with a focus on temperature-sensitive transport.
• Robust supplier evaluation, regulatory validation, and supply chain diversification are key to mitigating risks associated with raw material shortages or regulatory changes.

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FAQs

1. Who are the primary suppliers of API for DARTISLA ODT?
Major API suppliers include Sun Pharmaceutical Industries, Aurobindo Pharma, and specialized manufacturers like Futo Pharma, all adhering to strict GMP standards.

2. How do excipient suppliers contribute to the performance of DARTISLA ODT?
Excipient suppliers like FMC and Roquette supply disintegrants, fillers, and binders that enable rapid disintegration and optimal bioavailability.

3. What role do CMOs play in the DARTISLA ODT supply chain?
CMOs such as Catalent and Recipharm handle formulation development, scale-up, and commercial manufacturing, ensuring consistent product quality.

4. What are the key considerations in selecting distribution partners for DARTISLA ODT?
Regulatory compliance, temperature-controlled logistics, global reach, and supply chain transparency are critical factors.

5. How is supply chain resilience impacting DARTISLA ODT manufacturing?
Diversification of suppliers, strategic inventory management, and flexible manufacturing capabilities are essential to mitigate disruptions.

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References
[1] Good Manufacturing Practice (GMP) guidelines, U.S. Food and Drug Administration (FDA).
[2] Market analysis reports on pharmaceutical excipient providers, industry publications.
[3] Company websites and annual reports for Catalent, Recipharm, FMC, Roquette.
[4] Regulatory compliance standards for pharmaceutical ingredients, EMA & FDA guidelines.