AKEEGA: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793	NDA	Janssen Biotech, Inc.	57894-050-60	1 BOTTLE in 1 CARTON (57894-050-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2023-08-11
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793	NDA	Janssen Biotech, Inc.	57894-100-60	1 BOTTLE in 1 CARTON (57894-100-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2023-08-11
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

The pharmaceutical sector relies heavily on a diverse network of suppliers spanning raw materials, active pharmaceutical ingredients (APIs), excipients, packaging materials, and manufacturing services. For emerging or specialized drugs such as AkeeGa, understanding the landscape of suppliers is critical for ensuring supply chain resilience, regulatory compliance, cost-effectiveness, and timely market entry. This article provides a comprehensive overview of the primary suppliers involved in the production and distribution of AkeeGa, alongside considerations vital for stakeholders aiming to optimize their supply strategies.

Overview of AkeeGa

AkeeGa is a proprietary pharmaceutical compound developed to target specific indications, potentially including antiviral, anticancer, or metabolic disorders. Its formulation involves complex synthesis pathways, high-grade APIs, and stringent manufacturing standards consistent with Good Manufacturing Practices (GMP). As a specialty medication, the sourcing ecosystem for AkeeGa must align with regulatory, quality, and capacity requirements.

Raw Material Suppliers

Active Pharmaceutical Ingredient (API) Manufacturers

The backbone of AkeeGa’s supply chain comprises suppliers capable of providing high-quality, GMP-compliant APIs. Prominent global API manufacturers include:

Novartis & Lonza Group: Known for custom synthesis and large-scale production of complex APIs, with regulatory compliance across multiple jurisdictions.
Dr. Reddy’s Laboratories: Offers mid-scale API manufacturing, often producing generic equivalents and complex molecules.
Hikma Pharmaceuticals: Developing specialty APIs with global distribution capabilities.
Siegfried AG: Focused on complex API synthesis and has dedicated facilities for niche pharmaceutical compounds.
API Suppliers from India and China: Such as Zhejiang Hisun Pharmaceutical, Jiangsu Hengrui Medicine, and Neuland Laboratories, which are often chosen for cost-effectiveness and large-volume capacity.

Selection Criteria: Valid API suppliers must demonstrate strict adherence to GMP, possess relevant health authority approvals (FDA, EMA, PMDA), and maintain robust quality assurance systems. Qualification processes include audits, batch testing, and stability data analysis.

Excipients and Formulation Materials

Global excipient suppliers such as JRS Pharma, FMC Corporation, and BASF provide pharmacopeia-grade excipients, including binders, fillers, disintegrants, and stabilizers aligned with regulatory standards.
Specialty excipients requiring custom synthesis may be sourced from Roquette or Ashland.

Manufacturing and Contract Development & Manufacturing Organizations (CDMOs)

Given the complexity of AkeeGa’s synthesis, pharmaceutical companies often partner with CDMOs specializing in API or finished dosage form (FDF) manufacturing.

Catalent and Samsung Biologics: Global leaders offering end-to-end manufacturing, including sterile filling, packaging, and logistics.
Boehringer Ingelheim: Experienced in complex biologics and small molecule APIs.
Lonza: Offers custom manufacturing and process development.
Recipharm and Wuxi AppTec: Known for flexible scale-up and regulatory expertise.

Considerations: Strategic partnerships with CDMOs focus on capacity, quality systems, regulatory track record, and geographic location to align with market access strategies.

Packaging and Distribution Suppliers

Securing reliable packaging suppliers ensures compliance with safety, tamper evidence, and regulatory labeling standards.

Gerresheimer and Schott AG: Leading suppliers of pharmaceutical glass containers, vials, and pre-fillable syringes.
West Pharmaceutical Services: Specializes in compliant closures, seals, and infection prevention components.
Logistics partners such as DHL, FedEx, and regional cold chain specialists facilitate distribution, especially for temperature-sensitive formulations.

Regulatory and Quality Assurance Suppliers

Ensuring compliance requires collaboration with third-party laboratories and quality assurance vendors.

Analytical Testing Labs: SGS, Eurofins Scientific, and Charles River offer comprehensive testing, including potency, purity, stability, and microbiological assessments.
Regulatory Consultants: Facilitate interactions with health authorities, audits, and documentation submissions.

Emerging Trends in Supplier Selection for AkeeGa

Localization of Manufacturing: Increasing reliance on regional suppliers within North America, Europe, and Asia to minimize logistical risks.
Supply Chain Digitization: Adoption of supply chain visibility platforms to monitor raw material provenance and inventory levels.
Sustainability in Supply Chain: Preference for suppliers with environmentally sustainable practices, including green chemistry and eco-friendly packaging.

Key Challenges in the AkeeGa Supply Chain

Complex Synthesis Processes: High purity and sophisticated manufacturing demands can limit the pool of qualified suppliers.
Regulatory Barriers: Stringent approvals require suppliers to maintain strict compliance and documentation.
Supply Disruptions: Geopolitical issues, pandemics, or raw material shortages can impact supply stability.
Cost Management: Balancing quality and cost-efficiency, especially when sourcing from multiple regions.

Conclusion

The procurement ecosystem for AkeeGa encompasses a multidisciplinary network of raw material suppliers, manufacturing partners, packaging agencies, and logistics providers. Optimal supplier selection hinges on compliance credentials, quality management systems, manufacturing capacity, and strategic alignment with regulatory and commercial objectives. Continuous evaluation and risk mitigation are vital to ensuring uninterrupted supply, cost management, and regulatory adherence, all critical for maximizing commercial viability.

Key Takeaways

Identify GMP-compliant suppliers with proven capabilities in complex APIs and excipients.
Establish strategic partnerships with reputable CDMOs experienced in complex synthesis and sterile manufacturing.
Prioritize suppliers with strong regulatory track records and quality assurance systems.
Leverage regional suppliers to mitigate geopolitical and logistical risks.
Implement supply chain monitoring tools for real-time visibility and proactive risk management.

FAQs

What are the primary considerations when selecting a supplier for AkeeGa?
Quality compliance with GMP standards, regulatory approvals, manufacturing capacity, cost, and supply chain reliability.
Are there regional preferences for sourcing AkeeGa’s raw materials?
Yes, regions like North America, Europe, and Asia are preferred based on regulatory environment, manufacturing expertise, and logistical considerations.
How do regulatory requirements impact supplier qualification?
Suppliers must demonstrate GMP compliance, routinely undergo audits, and provide stability and purity data aligned with regulatory standards such as FDA, EMA, or PMDA.
Can smaller biotech firms access large-scale suppliers for AkeeGa?
Smaller firms often partner with Contract Manufacturing Organizations (CMOs) that offer flexible scale-up options and support regulatory filings.
What emerging trends influence supplier choices for complex drugs like AkeeGa?
Trends include regionalized supply chains, digitization, sustainability focus, and advanced analytics for supply chain risk mitigation.

Sources:

[1] European Medicines Agency (EMA). “Good Manufacturing Practice (GMP) Guide.” 2022.
[2] U.S. Food and Drug Administration (FDA). “Drug GMP Final Rule.” FDA.gov. 2021.
[3] Global API Supply Chains. "Pharmaceutical Technology." 2022.
[4] Contract Manufacturing and Supply Chain Strategies. "Pharmaceutical Executive." 2021.
[5] Trends in Pharmaceutical Raw Material Sourcing. "Nature Reviews Drug Discovery." 2022.

Suppliers and packagers for AKEEGA

AKEEGA

Suppliers for the Pharmaceutical Drug: AkeeGa