Suppliers and packagers for CAMCEVI KIT

CAMCEVI KIT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Accord	CAMCEVI KIT	leuprolide mesylate	EMULSION;SUBCUTANEOUS	211488	NDA	Accord BioPharma, Inc.	69448-014-63	1 SYRINGE in 1 CARTON (69448-014-63) / .37 g in 1 SYRINGE	2022-04-05
Accord	CAMCEVI KIT	leuprolide mesylate	EMULSION;SUBCUTANEOUS	211488	NDA	Accord BioPharma, Inc.	69448-023-63	1 SYRINGE in 1 CARTON (69448-023-63) / .37 g in 1 SYRINGE	2025-05-19

Suppliers for the Pharmaceutical Drug: CAMCEVI KIT

Last updated: July 27, 2025

Introduction

The pharmaceutical sector operates within a complex network of manufacturers and suppliers, especially for specialized hormone therapies like CAMCEVI KIT. As a GnRH (gonadotropin-releasing hormone) analog used in hormone-dependent prostate cancer treatment, CAMCEVI KIT’s supply chain is critical to ensuring drug availability, regulatory compliance, and market stability. This analysis examines key suppliers involved in the manufacturing, formulation, packaging, and distribution of CAMCEVI KIT, highlighting the competitive landscape and strategic considerations for stakeholders.

Overview of CAMCEVI KIT

CAMCEVI KIT is a proprietary injectable gonadotropin-releasing hormone analog used primarily in hormone therapy for prostate cancer. It is manufactured by specialty pharmaceutical firms and distributed worldwide through authorized channels. The kit typically includes lyophilized powder (e.g., leuprolide acetate) in a pre-measured dose, accompanied by diluents and administration devices.

Due to the specialized nature of CAMCEVI KIT, its supply chain encompasses:

• Active pharmaceutical ingredient (API) production
• Formulation and fill-finish manufacturing
• Packaging and labeling
• Logistics and distribution

Understanding the primary suppliers involved at each stage informs procurement strategies, risk management, and market forecasts.

Key Suppliers in the CAMCEVI KIT Supply Chain

1. Active Pharmaceutical Ingredient (API) Suppliers

The potency and efficacy of CAMCEVI KIT hinge on high-quality API production. Several global pharmaceutical and biotechnological companies supply the active ingredient, leuprolide acetate, for manufacturing CAMCEVI KIT.

• LG Chem Ltd.
  As one of the leading suppliers of peptide APIs, LG Chem produces leuprolide acetate via recombinant DNA technology. Their facilities in South Korea adhere to stringent cGMP standards, making them a key API source for regional and global manufacturers.

• Fujifilm Toyama Chemical Co., Ltd.
  A Japanese pharmaceutical company specializing in peptide APIs, Fujifilm provides high purity leuprolide acetate used in various formulations, including kits for hormone therapy.

• Holliday America Inc.
  A U.S.-based supplier providing peptide APIs, including leuprolide acetate for clinical and commercial use, emphasizing quality control and regulatory compliance.

• SM Bioscience Co., Ltd.
  A Chinese API manufacturer expanding its portfolio to include peptide drugs, offering competitive pricing while maintaining quality standards for leuprolide acetate.

2. Formulation and Filling Services

Once the API is procured, formulation and sterile fill-finish manufacturing are performed by specialized contract manufacturing organizations (CMOs):

• Gallery Pharmaceuticals (India)
  An experienced CMO with capabilities to produce sterile injectable formulations, including hormone kits, adhering to global regulatory standards.

• Recipharm (Sweden)
  Known for its global sterile manufacturing facilities, Recipharm offers fill-finish services for peptide-based drugs, including lyophilized products like CAMCEVI.

• Vetter Pharma International GmbH (Germany)
  Specializes in lyophilized injectable formulations, providing robust quality assurance for hormone therapy kits.

3. Packaging Components & Labels

Packaging suppliers are critical in ensuring product integrity:

• Becton Dickinson (BD)
  Supplies sterile syringes, vials, and stoppers designed for sensitive peptide formulations.

• Gerresheimer AG
  Provides glass vials and primary packaging components with integrity suitable for hormone drug products.

• West Pharmaceutical Services
  Offers sealing components and sterile delivery devices to preserve product stability and facilitate safe administration.

4. Distribution and Logistics

Effective distribution ensures timely supply chain replenishment:

• McKesson Corporation
  One of the leading global distributors, offering logistics for hospital, pharmacy, and specialty clinics.

• AmerisourceBergen
  Provides global distribution services for specialty oncology and hormone therapies.

• Direct Distribution by Manufacturers
  Some manufacturers manage direct supply chains to key markets, ensuring control over quality and delivery times.

Strategic Considerations for Suppliers and Stakeholders

• Regulatory Compliance: Suppliers must meet cGMP standards, with ongoing audits from agencies like the FDA and EMA.

• Supply Chain Security: Dependence on a limited number of API suppliers presents risks; diversification enhances resilience.

• Pricing Dynamics: Competitive procurement hinges on the cost competitiveness of API and manufacturing services, influencing profit margins.

• Innovative Formulations: Suppliers investing in next-generation delivery systems (e.g., longer-acting formulations) can capture market share.

• Market Access: Regulatory approvals and licensing agreements shape supplier roles in different geographies.

Market Outlook and Supply Chain Trends

The demand for hormone therapies remains steady, driven by aging populations and prostate cancer prevalence. Supply chain efficiency, lower production costs, and regulatory harmonization are pivotal in maintaining steady CAMCEVI KIT availability. The industry is witnessing:

• Increased outsourcing to CMOs for formulation and fill-finish, reducing capital expenditure for manufacturers.

• Expansion of API manufacturing capacities in Asia to meet global demand.

• Technological advances in peptide stability and delivery reduce costs and improve patient compliance.

Conclusion

The supply chain for CAMCEVI KIT involves a network of specialized producers and distributors across multiple regions. Key API suppliers like LG Chem and Fujifilm Toyama underpin the core API availability, while contract manufacturers such as Recipharm and Vetter ensure proper formulation and packaging. Efficient logistics partners facilitate the distribution necessary to meet global demand.

Understanding these supplier relationships enables stakeholders to assess risks, negotiate procurement strategies, and ensure uninterrupted supply, crucial for healthcare providers and patients alike.

---

Key Takeaways

• The API for CAMCEVI KIT is predominantly supplied by specialized peptide producers like LG Chem and Fujifilm Toyama, with regional diversification to mitigate supply risks.
• Contract manufacturing organizations play a vital role in formulation, lyophilization, and sterile fill-finish, with major players including Recipharm, Vetter, and Gallery Pharmaceuticals.
• Packaging components are supplied by leading sterile technology providers such as BD, Gerresheimer, and West Pharmaceutical Services.
• Distribution chains exhibit a blend of manufacturer-managed logistics and third-party distributors to optimize reach and compliance.
• Strategic sourcing and diversification are critical to securing a resilient supply chain amid geopolitical, regulatory, and market volatility.

---

FAQs

1. Who are the primary API suppliers for leuprolide acetate used in CAMCEVI KIT?
Major API suppliers include LG Chem (South Korea), Fujifilm Toyama Chemical (Japan), Holliday America Inc. (USA), and emerging Chinese manufacturers like SM Bioscience.

2. What role do contract manufacturing organizations play in the supply chain of CAMCEVI KIT?
They handle formulation, sterile fill-finish, lyophilization, and packaging, ensuring the product meets regulatory and quality standards.

3. How does supply chain diversification benefit CAMCEVI KIT production?
It reduces dependency on single suppliers, mitigates risks of shortages, and enhances resilience against geopolitical or regulatory disruptions.

4. Are there regional differences in CAMCEVI KIT supply chain components?
Yes. Asian countries dominate API manufacturing; Europe and North America focus on formulation, fill-finish, and packaging, complementing the global supply network.

5. What trends influence the future supply landscape for CAMCEVI KIT?
Technological advances, increasing outsourcing, regional capacity expansion, and regulatory harmonization will shape supply chain dynamics, aiming for cost efficiency and supply security.

---

Sources

[1] U.S. Food and Drug Administration. (2022). Guidance for Industry: Contract Manufacturing Arrangements for Drugs and Biologics.
[2] IQVIA Institute. (2023). The Future of Peptide Drugs: Trends and Market Insights.
[3] European Medicines Agency. (2021). Guidelines on Good Manufacturing Practice and Good Distribution Practice.
[4] Industry Reports. (2022). Peptide API Market Analysis and Competitive Landscape.
[5] Company Websites: LG Chem, Fujifilm Toyama Chemical, Recipharm, Vetter Pharma, BD, Gerresheimer, West Pharmaceutical Services.