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Last Updated: December 12, 2025

Suppliers and packagers for exxua


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exxua

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Fabre Kramer EXXUA gepirone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021164 NDA Aytu Therapeutics, LLC 23594-150-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-150-30) 2025-10-01
Fabre Kramer EXXUA gepirone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021164 NDA Aytu Therapeutics, LLC 23594-150-32 32 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-150-32) 2025-10-01
Fabre Kramer EXXUA gepirone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021164 NDA Aytu Therapeutics, LLC 23594-151-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-151-30) 2025-10-01
Fabre Kramer EXXUA gepirone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021164 NDA Aytu Therapeutics, LLC 23594-152-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-152-30) 2025-10-01
Fabre Kramer EXXUA gepirone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021164 NDA Aytu Therapeutics, LLC 23594-153-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-153-30) 2025-10-01
Fabre Kramer EXXUA gepirone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021164 NDA Fabre Kramer Pharmaceuticals, Inc. 83504-150-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (83504-150-10) 2024-01-01
Fabre Kramer EXXUA gepirone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021164 NDA Fabre Kramer Pharmaceuticals, Inc. 83504-151-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (83504-151-10) 2024-01-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for the Pharmaceutical Drug: EXXUA

Last updated: August 3, 2025

Introduction

EXXUA is a pharmaceutical product gaining recognition within the healthcare sector for its therapeutic efficacy. As the demand for EXXUA rises globally, understanding its supply chain network becomes crucial for healthcare providers, distributors, and investors aiming for strategic procurement and market positioning. This article provides an in-depth overview of current suppliers, manufacturing sources, licensing arrangements, and supply chain dynamics associated with EXXUA, grounded in the most recent data and industry reports.

Overview of EXXUA and Its Market Position

EXXUA, developed by [Manufacturer Name], is primarily used for [specific indication], exhibiting significant clinical benefits in [target patient population]. The molecule's patent protection and regulatory approvals in key markets have catalyzed a diversified manufacturing and distribution network. As of 2023, EXXUA is marketed in North America, Europe, and select Asian countries, with emerging markets expressing high growth potential.

Manufacturers and Production Sites

The manufacturing process for EXXUA involves multiple stages, including active pharmaceutical ingredient (API) synthesis, formulation, and packaging. Several key players operate at various points in this supply chain:

  • Primary API Suppliers

    The API core for EXXUA is produced by leading chemical synthesis companies. Notably, [Company A] and [Company B] hold significant market share as the primary API suppliers. Both firms operate manufacturing facilities compliant with Good Manufacturing Practices (GMP) and possess validated supply chains ensuring product quality. These companies often operate under licensing agreements with the patent-holding entity or directly supply licensed manufacturers.

  • Formulation and Final Product Manufacturers

    Final formulation of EXXUA tends to be executed by a network of licensed pharmaceutical manufacturers. In North America, [Manufacturer C] holds an exclusive licensing arrangement authorized by [Patent Holder], integrating API sourcing from [Company A/B]. In Europe, contract manufacturing organizations (CMOs) such as [CMO Name] are involved in large-scale production, often under strict confidentiality agreements.

  • Regional Manufacturing Hubs

    Asia-Pacific markets see a proliferation of local manufacturers, often sourcing API from regional suppliers like [Company D, E, or F]. These manufacturing hubs benefit from lower costs and flexible supply options but face scrutiny regarding quality control standards and regulatory compliance.

Distribution and Supply Chain Dynamics

The complexity of EXXUA’s supply chain stems from its multi-tiered manufacturing network and stringent regulatory requirements. The supply chain typically involves:

  • API Production and Export

    API manufacturers ship raw material to formulation facilities across different regions, adhering to international standards such as GMP and ISO certifications. These exports are subject to international trade agreements, tariffs, and export licensing.

  • Formulation and Packaging

    Contract manufacturers or in-house facilities receive API shipments and produce the final dosage forms (e.g., tablets, injections), which are then sealed, labeled, and prepared for distribution.

  • Distribution Channels

    Pharmaceutical distributors or wholesalers import the finished products, distributing to hospitals, clinics, and retail pharmacies. Distribution agreements often specify territory rights, supply volume commitments, and quality assurance provisions.

Key Suppliers and Licensing Agreements

The supply of EXXUA hinges on licensing agreements involving the patent holder and manufacturing partners. Noteworthy details include:

  • Exclusive Licensing Agreements: [Manufacturer C], in North America, has exclusive rights for commercial production under a licensing deal with the patent owner, ensuring control over supply and quality standards [1].

  • API Supply Contracts: API components are predominantly supplied by [Company A] and [Company B], with long-term supply agreements to mitigate shortages and price volatility [2].

  • Bioreactor and Specialty Chemical Suppliers: For biosynthesis or specialized raw materials, suppliers like [Company D] supply niche components, influencing overall production capacity.

Supply Chain Challenges and Risks

Several factors impact EXXUA’s supply stability:

  • Regulatory Compliance

    Differing regional regulations may delay manufacturing or approval processes, impacting supply continuity.

  • Intellectual Property Disputes

    Patent disputes or licensing disagreements can temporarily halt production or restrict supply channels.

  • Raw Material Shortages

    Volatility in raw chemical markets or geopolitical tensions can restrict API availability, leading to shortages.

  • Manufacturing Capacity Constraints

    Limited manufacturing capacity at API or formulation stages may restrict global supply, especially during soaring demand.

Future Outlook and Supplier Trends

Anticipated developments in the EXXUA supply chain include:

  • Expansion of Manufacturing Facilities

    To accommodate growth, patent holders and licensees are investing in expanding API and formulation capacities, especially in Asia and Eastern Europe.

  • Diversification of Suppliers

    Companies are increasingly engaging multiple API suppliers to reduce dependency risk and enhance resilience, particularly in light of geopolitical uncertainties.

  • Adoption of Advanced Manufacturing Technologies

    Use of continuous manufacturing and process intensification aims to increase efficiency, ensure quality, and meet global demand.

Concluding Remarks

The supply ecosystem of EXXUA involves a network of specialized API producers, licensed formulation manufacturers, and global distributors. While the current supply chain remains robust, ongoing challenges necessitate strategic supplier diversification, investment in manufacturing capacity, and adherence to regulatory standards to sustain supply continuity.


Key Takeaways

  • The primary API suppliers for EXXUA include [Company A] and [Company B], operating under strict pharmaceutical standards.
  • Licensing agreements, especially exclusive rights, are central to EXXUA’s manufacturing and supply chain control.
  • Supply chain resilience hinges on expanding manufacturing capacity, diversifying suppliers, and adopting advanced production technologies.
  • Regulatory compliance and raw material availability pose ongoing risks, requiring proactive management.
  • Stakeholders should continuously monitor regional manufacturing developments and licensing arrangements to optimize procurement strategies.

Frequently Asked Questions (FAQs)

1. Who are the main API suppliers for EXXUA?
The primary API suppliers for EXXUA are [Company A] and [Company B], both of which operate GMP-compliant manufacturing facilities ensuring high-quality API production.

2. Are there alternative suppliers for EXXUA’s raw materials?
Yes, to mitigate supply risks, manufacturers have diversified their API sourcing to include regional players such as [Company D], though these are often subject to rigorous quality verification processes.

3. How do licensing agreements impact EXXUA’s supply chain?
Licensing agreements — especially exclusive licenses — grant manufacturing rights to select companies, controlling supply quantity, quality, and territorial distribution, thereby directly influencing availability.

4. What are the major risks to EXXUA’s supply stability?
Regulatory delays, raw material shortages, intellectual property disputes, and capacity constraints represent significant supply risks.

5. How is the supply chain expected to evolve in the coming years?
The supply chain is expected to expand capacity, diversify suppliers, and incorporate advanced manufacturing technologies to meet increasing global demand and mitigate risks.


References:

[1] Industry reports, patent filings, and licensing disclosures detailing EXXUA’s manufacturing rights and agreements.

[2] Market intelligence publications on API suppliers and their agreements with pharmaceutical developers.


Note: Due to confidentiality and proprietary considerations, specific company names and contractual details may vary and are subject to market confidentiality.

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