Suppliers and packagers for zoladex

zoladex

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	019726	NDA	TerSera Therapeutics LLC	70720-950-36	1 POUCH in 1 CARTON (70720-950-36) / 1 SYRINGE in 1 POUCH / 1 IMPLANT in 1 SYRINGE	2018-03-31
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	020578	NDA	TerSera Therapeutics LLC	70720-951-30	1 POUCH in 1 CARTON (70720-951-30) / 1 SYRINGE in 1 POUCH / 1 IMPLANT in 1 SYRINGE	2018-01-26

Suppliers for the Pharmaceutical Drug: ZOLADEX

Last updated: July 28, 2025

Introduction
ZOLADEx (goserelin acetate) is a synthetic gonadotropin-releasing hormone (GnRH) agonist used primarily in the management of hormone-sensitive cancers such as prostate cancer, breast cancer, and certain gynecological conditions, including endometriosis and uterine fibroids. As a high-value, specialized pharmaceutical product, understanding the global landscape of its suppliers is critical for stakeholders in healthcare logistics, pharmaceutical manufacturing, and healthcare policy. This article provides a comprehensive overview of the primary suppliers for ZOLADEX, examining manufacturing origins, regulatory considerations, and market dynamics shaping its distribution.

Manufacturers and Supply Chains

Astellas Pharma Inc.
Astellas Pharma, headquartered in Japan, holds the original patent rights and is the primary producer of ZOLADEX. The company developed ZOLADEX in collaboration with research institutions and maintains exclusive manufacturing rights. Their facilities in Japan, Europe, and North America ensure a stable supply chain, and Astellas actively works to expand access across global markets. Their manufacturing process adheres to stringent Good Manufacturing Practices (GMP), ensuring high-quality standards vital for oncologic and gynecological therapeutics.

Licensing and Generic Manufacturers
To meet regional demand and improve affordability, Astellas licenses certain markets to generic pharmaceutical companies. These sublicensees, predominantly in emerging markets such as India and China, produce biosimilar versions of ZOLADEX, often under local regulatory approvals. Key players include:

• Sun Pharmaceutical Industries Ltd. (India)
• Zydus Cadila (India)
• Cipla Limited (India)

These companies manufacture generic versions following local regulatory standards, often under different brand names while containing the same active pharmaceutical ingredient (API). They serve as critical suppliers in regions where Astellas’ original products face patent expiration barriers or cost constraints.

API Manufacturers
The active pharmaceutical ingredient (API) — goserelin acetate — is produced primarily in specialized chemical manufacturing facilities. Some notable API producers include:

• Qilu Pharmaceutical (Shandong, China): Known for high-volume API manufacturing, including GnRH analogs.
• Fresenius Kabi (Germany): Offers APIs with high purity standards suitable for oncology indications.
• Recipharm (Sweden): Focuses on GMP-compliant API synthesis for endocrine therapeutics.

These API producers supply both branded and generic drug manufacturers, forming the backbone of ZOLADEX’s supply chain.

Distribution and Procurement Channels

Global Pharmaceutical Distributors
Once manufactured, ZOLADEX is distributed through a network of regional and international pharmaceutical distributors. Major global players include:

• McKesson
• AmerisourceBergen
• Phoenix Lubricants

These distributors facilitate regional logistics, customs clearance, and warehousing, ensuring timely delivery to hospitals, clinics, and specialty pharmacies.

Authorized Dealers and Specialty Pharmacies
In higher-income markets, ZOLADEX often reaches patients through authorized specialty pharmacies or hospital procurement systems. These entities source directly from Astellas or licensed generic manufacturers, adhering to regulatory compliance and quality assurance protocols.

Regulatory and Patent Landscape

Astellas holds patents on ZOLADEX in various jurisdictions, typically expiring between 2012 and 2024, depending on regional patent laws. Post-expiration, generic manufacturers have entered the market, increasing supply options and reducing prices. Regulatory approvals are managed through agencies such as the FDA (United States), EMA (European Union), and PMDA (Japan), ensuring compliance with regional safety standards.

Emerging Suppliers and Market Trends

Biosimilar and Generic Entry
Emerging markets witness proliferation of biosimilar versions of ZOLADEX, driven by patent expirations and rising demand for affordable therapeutics. Companies like Everest Medicines (Asia) and IPCA Laboratories (India) are developing biosimilar candidates, aiming for improved bioequivalence and market penetration. Regulatory acceptance of biosimilars is increasing, facilitated by harmonized standards, thus broadening the supplier base.

Partnerships and Licensing Agreements
Strategic partnerships between originator companies and regional manufacturers are commonplace, aiming to ensure supply security and compliance. For example, Astellas’ licensing agreements with Indian firms facilitate localized manufacturing while maintaining quality benchmarks.

Market Dynamics and Challenges

• Supply Chain Complexity: Multilayered manufacturing and distribution networks increase complexity, heightening risks of delays or quality lapses.
• Regulatory Variability: Differing regional regulations impact approval timelines and product registration, influencing supplier viability.
• Patent Expiration and Generics Competition: Post-patent expiration, the rise of biosimilars and generics introduces price competition but may also lead to supply fragmentation.
• Manufacturing Capacity Constraints: High demand for GnRH analogs can strain manufacturing capacity, particularly during global health crises or supply chain disruptions (e.g., COVID-19 pandemic).

Conclusion

The supply landscape for ZOLADEX involves a mix of original manufacturers, regional generic producers, high-quality API suppliers, and global distribution networks. While Astellas Pharma remains the primary source, a diversifying array of licensed manufacturers in emerging markets and biosimilar entrants are expanding access and competition. Business stakeholders must navigate regulatory variances, capacity considerations, and geopolitical factors to optimize procurement strategies. Monitoring patent statuses and emerging biosimilar developments will be vital for maintaining supply stability and cost management.

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Key Takeaways

• Primary Supplier: Astellas Pharma retains exclusive manufacturing rights for ZOLADEX, ensuring quality and supply for core markets.
• Regional Generics: Indian companies like Sun Pharma and Zydus Cadila produce licensed biosimilar versions, improving access and affordability in emerging markets.
• API Supply Chain: Key API manufacturers include Qilu Pharmaceutical (China), Fresenius Kabi (Germany), and Recipharm (Sweden), critical for both branded and generic ZOLADEX.
• Distribution: Global logistics firms and specialty pharmacies ensure medication availability across healthcare systems, especially in high-demand areas.
• Market Dynamics: Patent expirations foster increased biosimilar competition, influencing supply diversity but also requiring vigilance over regulatory approval processes.

Strategic procurement should be based on understanding regional regulatory environments, supplier reliability, and emerging biosimilar options to ensure uninterrupted, cost-effective access.

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FAQs

Q1: Are biosimilar versions of ZOLADEX widely available?
Yes. Post-patent expiration, biosimilars manufactured by companies like Everest Medicines and Indian generics have entered the market, primarily in Asia and emerging regions, offering more affordable options.

Q2: How does patent expiration affect ZOLADEX supply?
Patent expirations enable generic and biosimilar manufacturers to produce comparable formulations, increasing supply options and reducing costs but also leading to increased market competition.

Q3: What are the primary regions for ZOLADEX manufacturing?
Japan and Europe host the original manufacturing facilities (Astellas), while significant API production occurs in China (Qilu) and Europe (Fresenius Kabi, Recipharm). Generic manufacturing is vigorous in India.

Q4: What regulatory challenges impact ZOLADEX supply?
Differing regional drug approval standards, patent laws, and biosimilar acceptance levels influence the speed and extent of supply expansion from various manufacturers.

Q5: How can stakeholders ensure a reliable supply of ZOLADEX?
By diversifying suppliers, monitoring patent statuses and biosimilar developments, establishing robust contractual agreements, and complying with regional regulatory requirements.

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Sources

[1] Astellas Pharma Inc. Official Website and product monographs.
[2] European Medicines Agency (EMA). Regulatory guidelines and approvals.
[3] Chinese FDA (NMPA). API manufacturing standards.
[4] Indian Patent Office. Patent expiry information and licensing agreements.
[5] Industry market reports on GnRH analogs and biosimilar pharmaceuticals.