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Suppliers and packagers for generic pharmaceutical drug: goserelin acetate
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goserelin acetate
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Goserelin Acetate
Introduction
Goserelin acetate is a synthetic gonadotropin-releasing hormone (GnRH) analogue widely utilized in the treatment of hormone-sensitive cancers, including prostate cancer, breast cancer, endometriosis, and uterine fibroids. Its efficacy hinges on precise formulation and pharmacokinetic stability, which demands high-quality suppliers capable of consistent manufacturing according to stringent regulatory standards. This article provides a comprehensive overview of leading suppliers for Goserelin acetate, highlighting their capabilities, geographic presence, regulatory compliance, and impact on the global pharmaceutical supply chain.
Overview of Goserelin Acetate
Goserelin acetate functions primarily as an LHRH (luteinizing hormone-releasing hormone) agonist, initially stimulating and subsequently downregulating the pituitary gland's secretion of luteinizing hormone and follicle-stimulating hormone. Its therapeutic formulations are typically administered via subcutaneous or intramuscular injection, and ensuring the supply chain robustness is vital for continual patient access. The manufacturing of Goserelin acetate involves complex peptide synthesis and peptide stability considerations, requiring suppliers with advanced biotechnological capabilities.
Major Suppliers of Goserelin Acetate
1. AstraZeneca
Overview: AstraZeneca is the original developer of Goserelin acetate, marketed under brand names such as Zoladex®. The company maintains a significant control over the supply chain, leveraging its extensive manufacturing facilities primarily located in Europe and North America.
Capabilities: AstraZeneca's manufacturing processes are validated, piloting high-purity peptide synthesis with certified Good Manufacturing Practice (GMP) standards. They also provide comprehensive distribution networks, ensuring the drug's availability in global markets.
Regulatory Compliance: As an innovator, AstraZeneca’s Goserelin products are pre-approved by major regulatory authorities including the FDA, EMA, and MHRA, ensuring adherence to international standards.
Key Note: Companies sometimes seek licensed generics or biosimilar versions to reduce costs, but AstraZeneca remains a dominant supplier for original formulations.
2. Sun Pharmaceutical Industries Ltd.
Overview: Sun Pharma is a major Indian pharma company expanding into peptide APIs, including GnRH analogues like Goserelin acetate.
Capabilities: They possess robust peptide synthesis facilities with GMP certification, capable of supplying both active pharmaceutical ingredients (API) and finished formulations. The company's strategic investments in R&D allow for high-quality generics production.
Regulatory Compliance: Sun Pharma’s APIs meet standards set by the USFDA, EMA, and local regulatory bodies, facilitating their exports globally.
Market Position: While primarily known for generics, Sun Pharma’s Goserelin offerings are increasingly gaining acceptance in emerging markets.
3. Ferring Pharmaceuticals
Overview: Ferring specializes in peptide and hormone-based products, including GnRH analogues. They produce Goserelin acetate for specific markets, primarily within Europe and select Asian countries.
Capabilities: Ferring’s research and manufacturing facilities emphasize biologics and peptide stability, enabling high-quality API production.
Regulatory Compliance: Their products undergo rigorous quality control aligned with international standards, enabling broad-market distribution.
Strategic Focus: Ferring focuses on therapeutic areas like reproductive health and oncology, positioning Goserelin as a core part of their peptide portfolio.
4. Apotex Inc.
Overview: Canadian-based Apotex manufactures Goserelin acetate as part of its peptide API portfolio, focusing on cost-effective generics.
Capabilities: Their GMP-certified facilities produce high-purity peptide APIs suitable for complex formulations.
Regulatory Status: Apotex's APIs are licensed and approved in various jurisdictions, with an emphasis on compliance and quality control.
Market Role: They serve global markets, especially in Latin America, Africa, and Asia, as key suppliers of affordable Goserelin acetate.
5. Teva Pharmaceutical Industries Ltd.
Overview: Teva’s inclusion in the Goserelin supply chain stems from their extensive portfolio of peptide APIs and generics.
Capabilities: The company’s manufacturing plants are GMP-certified, with advanced peptide synthesis technology. Their focus is on ensuring supply continuity for their global client base.
Regulatory Compliance: Teva’s products consistently meet strict international regulatory standards, facilitating exports worldwide.
Emerging and Regional Suppliers
In addition to established players, newer entrants and regional suppliers are increasingly contributing to Goserelin acetate supply, especially in fast-growing markets:
- Hetero Drugs: India-based manufacturer expanding peptide API capabilities.
- Neuland Laboratories: Focused on peptide and steroid APIs for emerging markets.
- Aspen Pharmacare: South African pharmaceutical producer with growing peptide API portfolio.
These suppliers often offer cost advantages but may face challenges related to regulatory approvals, necessitating comprehensive quality assurance when integrating their products into treatment protocols.
Regulatory Landscape and Quality Standards
Given the injectable nature of Goserelin acetate, suppliers must comply with rigorous GMP standards enforced by agencies such as the USFDA, EMA, MHRA, and equivalent bodies in their respective countries. Moreover, batch-to-batch consistency, purity, and stability are critical factors influencing supplier selection.
Importantly, the increasing prominence of biosimilar and generic manufacturers introduces variability in quality standards; hence, due diligence is imperative. Suppliers with validated manufacturing processes, robust quality management systems, and proven track records are preferred.
Supply Chain Challenges and Considerations
- Global Demand Fluctuations: The increasing adoption of Goserelin in oncology and reproductive health heightens supply demands, stressing manufacturing capacities.
- Regulatory Hurdles: Differing regulatory pathways for generics and biosimilars can delay market entry and approval.
- Intellectual Property Rights: Patent expirations of original formulations influence market dynamics, enabling the rise of new suppliers.
- Quality Assurance: Due diligence regarding supplier certifications, batch testing, and compliance history is vital for minimizing risks.
Conclusion
The supply landscape for Goserelin acetate features a mix of original manufacturers, such as AstraZeneca, and a global network of qualified generics producers like Sun Pharma, Apotex, and Teva. Key considerations for stakeholders include regulatory compliance, manufacturing capacity, product quality, and supply chain stability. As demand continues to grow, collaboration with certified suppliers capable of maintaining high standards and consistent delivery remains critical for healthcare providers and pharmaceutical companies seeking reliable sources of this vital oncologic and reproductive health therapy.
Key Takeaways
- AstraZeneca remains the primary original developer and supplier of Goserelin acetate, with a significant influence over the supply chain.
- Generics manufacturers such as Sun Pharma, Apotex, and Teva play a vital role in expanding access, especially in emerging markets.
- Suppliers must adhere to stringent GMP and international regulatory standards to ensure drug safety and efficacy.
- Supply chain resilience depends on diversification of suppliers, regulatory compliance, and capacity management.
- Emerging regional suppliers can offer cost advantages but require thorough vetting to meet quality and regulatory expectations.
FAQs
Q1: What are the main factors to consider when selecting a Goserelin acetate supplier?
A1: Critical factors include regulatory compliance, manufacturing capacity, consistent product quality, GMP certification, reputation for reliability, and supply chain stability.
Q2: Are biosimilar versions of Goserelin acetate available in the market?
A2: Yes, several biosimilar versions are emerging, primarily from manufacturers in India, China, and other countries, subject to regulatory approval in different regions.
Q3: How do regulatory differences impact Goserelin acetate supply?
A3: Variations in approval processes, standards, and documentation requirements can delay registration and distribution, necessitating manufacturers’ compliance with specific regional regulations.
Q4: What does the future of Goserelin acetate supply look like?
A4: Increasing demand driven by oncology and reproductive health, along with patent expirations of original products, will likely expand the supplier base, including biosimilars and regional producers.
Q5: How has the COVID-19 pandemic affected Goserelin acetate manufacturing and supply?
A5: The pandemic disrupted supply chains, caused manufacturing delays, and increased demand for certain pharmaceuticals, emphasizing the need for diversified supplier networks and supply chain resilience strategies.
References
- [1] AstraZeneca Zoladex Product Information.
- [2] Sun Pharmaceutical Industry Ltd. Peptide API Portfolio.
- [3] Ferring Pharmaceuticals Official Website.
- [4] Apotex Inc. API Manufacturing Capabilities.
- [5] Teva Pharmaceuticals Global API Supply.
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