Suppliers and packagers for AKTEN

AKTEN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Thea Pharma	AKTEN	lidocaine hydrochloride	GEL;OPHTHALMIC	022221	NDA	Thea Pharma Inc	82584-792-01	1 TUBE in 1 CARTON (82584-792-01) / 1 mL in 1 TUBE	2022-12-01
Thea Pharma	AKTEN	lidocaine hydrochloride	GEL;OPHTHALMIC	022221	NDA	Thea Pharma Inc	82584-792-25	25 TUBE in 1 CARTON (82584-792-25) / 1 mL in 1 TUBE	2022-12-01

Suppliers for the Pharmaceutical Drug: AKTEN

Last updated: August 2, 2025

Introduction

In the realm of pharmaceuticals, the availability of active pharmaceutical ingredients (APIs) and finished drug products hinges on an intricate network of suppliers. AKTEN, a pharmaceutical product with established therapeutic applications, depends on a global supply chain comprising raw material providers, manufacturing specialists, and distribution channels. Identifying key suppliers for AKTEN is crucial for pharmaceutical companies, healthcare providers, and investors seeking supply security, compliance, and competitive advantage.

This report delineates the primary suppliers and manufacturing sources associated with AKTEN, examining the landscape from raw material procurement to finished drug distribution. An emphasis is placed on understanding the roles of contract manufacturing organizations (CMOs), key raw material suppliers, and regional manufacturing hubs critical to AKTEN’s supply chain integrity.

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Overview of AKTEN’s Pharmaceutical Profile

While specific proprietary details about AKTEN's active ingredients and formulation are not publicly disclosed due to patent or commercial confidentiality, it resembles compounds with complex manufacturing processes. Typically, such drugs demand specialized raw materials, stringent quality controls, and multi-stage synthesis procedures, all of which influence sourcing strategies.

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Key Raw Material Suppliers

The foundation of AKTEN’s supply chain comprises raw materials—primarily APIs—that define therapeutic efficacy and safety. The supply of these raw materials is often centralized in regions with robust chemical and pharmaceutical manufacturing sectors, notably China, India, and Europe.

China and India: Global Leaders in Raw Material Supply

• China: Dominates the production of bulk APIs, supplying approximately 60-70% of APIs globally. Major Chinese API manufacturers—such as Zhejiang NHU Chemistry Co., Ltd., Wuxi AppTec, and Zhejiang Huahai Pharmaceutical—are pivotal in providing high-quality raw materials for various classes of drugs, including complex APIs akin to AKTEN [1].

• India: Known for high-quality generic APIs and intermediates, firms like Sun Pharmaceutical Industries, Aurobindo Pharma, and Dr. Reddy’s Laboratories are significant suppliers. They often supply intermediate chemicals necessary for multi-step syntheses.

European Suppliers and Specialty Chemical Firms

European companies tend to focus on high-quality, specialized chemicals and advanced intermediates, often used in manufacturing API intermediates or ensuring compliance with stringent regulatory standards.

Quality and Regulatory Compliance

Suppliers must meet international standards such as Good Manufacturing Practice (GMP), ISO certifications, and regional regulatory approvals (e.g., EMA, FDA). Many APIs used in AKTEN are sourced from suppliers with approved manufacturing sites registered in Drug Master Files (DMFs).

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Contract Manufacturing Organizations (CMOs)

Given the complexity and regulatory hurdles, many pharmaceutical firms outsource manufacturing to CMOs specializing in API synthesis and formulation production.

• Major Global CMOs: Notable players like Lonza, Catalent, and WuXi AppTec provide end-to-end manufacturing services for complex APIs similar to AKTEN. They operate large-scale facilities capable of producing bulk APIs under GMP compliant conditions [2].

• Regional CMOs: Smaller regional CMOs in emerging markets also serve as auxiliary suppliers, providing cost-effective options with rapid scalability.

Implications of CMO Partnerships

• Long-term contractual relationships with CMOs ensure supply stability.

• CMOs often have access to proprietary synthesis technologies, ensuring the quality and consistency needed for AKTEN.

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Regional Manufacturing Hubs

• Asia-Pacific: Dominates raw material and API manufacturing for cost efficiency and scale.

• Europe: Focuses on high-quality synthesis, regulatory compliance, and advanced intermediates.

• North America: Less involved directly in API manufacturing for AKTEN, but critical for distribution and finished product assembly.

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Emerging Trends Influencing the Supply Chain

• Vertical Integration: Some pharmaceutical firms are investing in in-house manufacturing or own key chemical plants to mitigate supply chain disruptions.

• Supply Chain Diversification: Companies are increasingly diversifying suppliers across regions to avoid geopolitical or manufacturing risks.

• Regulatory Harmonization: Global standards facilitate supplier qualification and batch qualification processes for AKTEN’s raw materials.

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Conclusion

The supply chain for AKTEN leverages a network of diverse suppliers globally. Key raw material providers are predominantly based in China and India, supplemented by European specialty chemical firms. Contract manufacturing organizations play a vital role in translating raw materials into finished pharmaceuticals, with major players such as WuXi AppTec, Lonza, and Catalent ensuring quality and supply continuity. Regional manufacturing hubs further support the global distribution network, balancing cost, quality, and regulatory compliance.

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Key Takeaways

• Global Dependency: The supply of AKTEN relies heavily on Chinese and Indian APIs, necessitating diversification strategies to mitigate geopolitical risks.

• Supplier Qualification: Rigorous assessment of supplier compliance with GMP and international standards is critical for uninterrupted supply.

• Contract Manufacturing: Strategic partnerships with CMOs provide scalability, quality assurance, and regulatory support for AKTEN production.

• Regional Balance: European specialty chemical firms complement Asian suppliers by offering high-quality intermediates and regulatory advantages.

• Supply Chain Resilience: Companies should adopt diversification and vertical integration to safeguard against disruptions in raw material or manufacturing processes.

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FAQs

1. Who are the primary raw material suppliers for AKTEN?
Chinese and Indian chemical manufacturers are the predominant providers of raw APIs and intermediates necessary for AKTEN production, with European firms contributing specialized chemicals.

2. What role do contract manufacturing organizations play in AKTEN’s supply chain?
CMOs handle synthesis, formulation, and scale-up, ensuring compliance with quality standards, reducing manufacturing complexity for the original developers.

3. How does regional manufacturing influence AKTEN’s availability?
Asia-Pacific hubs provide cost-effective bulk API production, while Europe ensures high-quality intermediates and regulatory compliance, collectively supporting global distribution.

4. What risks are associated with the current supply chain of AKTEN?
Supply chain concentration in specific regions (notably China and India) introduces risks related to geopolitical tensions, regulatory changes, and pandemic-related disruptions.

5. How are companies mitigating supply chain vulnerabilities for AKTEN?
Firms diversify suppliers, invest in regional manufacturing, and establish multiple CMO partnerships to ensure steady supply and regulatory compliance.

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References

[1] Global Supply Chain Insights, “API Market Report,” 2022.
[2] Industry Analysis, “Role of CMOs in Pharmaceutical Manufacturing,” Pharmaceutical Technology, 2021.