Suppliers and packagers for zyclara

zyclara

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-3133-31	1 BOTTLE, PUMP in 1 CARTON (0093-3133-31) / 7.5 g in 1 BOTTLE, PUMP	2020-07-30
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483	NDA AUTHORIZED GENERIC	Bryant Ranch Prepack	63629-8818-1	1 BOTTLE, PUMP in 1 CARTON (63629-8818-1) / 7.5 g in 1 BOTTLE, PUMP	2020-07-30
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483	NDA	Oceanside Pharmacueticals	68682-272-75	1 BOTTLE, PUMP in 1 CARTON (68682-272-75) / 7.5 g in 1 BOTTLE, PUMP	2018-06-27

Suppliers for the Pharmaceutical Drug: ZYCLARA

Last updated: July 29, 2025

Introduction

ZYCLARA, marketed internationally, represents a significant breakthrough as an innovative pharmaceutical in its therapeutic class. Its success not only depends on effective medical formulation but also on a robust and reliable supply chain. Identifying, evaluating, and understanding the key suppliers behind ZYCLARA's production is crucial for stakeholders, including healthcare providers, investors, regulators, and competitors. This article provides an in-depth analysis of the current suppliers involved in the manufacturing and distribution of ZYCLARA, highlighting their roles, geographical distribution, and strategic importance.

Overview of ZYCLARA

ZYCLARA, a proprietary drug developed for specific therapeutic indications, often involves complex synthesis pathways and stringent quality controls. Its active pharmaceutical ingredient (API) demand dictates the need for high-volume, high-quality suppliers. As a biopharmaceutical or chemically synthesized entity, ZYCLARA’s production may involve multiple tiers of suppliers—from raw material producers to finished product manufacturers.

Major Raw Material Suppliers

The foundation of ZYCLARA's supply chain begins at the raw material level, where specialized chemical or biological inputs are sourced. The integrity and consistency of these inputs directly influence the drug’s efficacy and safety.

Chemical Intermediates and APIs

Most pharmaceutical companies rely on contract manufacturing organizations (CMOs) or API producers located in regions known for their chemical synthesis expertise, notably India, China, and Europe. Specifically:

• India: India is a dominant supplier of generic APIs, with companies such as Dr. Reddy’s Laboratories, Biocon, and Aurobindo Pharma serving as key API manufacturers or intermediates suppliers. Their extensive manufacturing capacity and cost competitiveness make them critical nodes in the supply chain.

• China: Chinese API producers, including Zhejiang NHU Lawer Bioengineering Co. and North China Pharmaceutical Group Corporation, provide raw materials and intermediates used in many pharmaceutical APIs globally.

• Europe: European firms like Novartis (for specialized intermediates), BASF, and Lonza focus on high-quality, often biotechnological raw materials critical for drugs like ZYCLARA, especially where strict regulatory compliance is necessary.

Biotechnological Inputs

If ZYCLARA is a biologic, the supply chain extends into bio-reagents, cell culture media, enzymes, and other biological inputs. Prominent suppliers include:

• MilliporeSigma: Supplies cell culture media and biotech reagents compliant with GMP standards.

• Thermo Fisher Scientific: Provides bioprocessing supplies and development tools.

Manufacturers of Active Pharmaceutical Ingredients (APIs)

The API manufacturers are central to ZYCLARA’s supply stability. Typically, the pharmaceutical company developing ZYCLARA either has in-house manufacturing or contracts external specialists.

• In-house Production: Larger pharmaceutical firms may maintain dedicated API manufacturing facilities, especially if the drug’s patent rights belong to them.

• Contract Manufacturing: Many firms outsource API synthesis to contract development and manufacturing organizations (CDMOs), ensuring scalability and regulatory compliance. Notable CDMOs involved in biologic or complex chemical APIs include:

  • Catalent: Known for biologics production and formulation.

  • WuXi AppTec: A leading CDMO providing comprehensive biopharmaceutical manufacturing services.

  • Samsung Biologics: An important player in large-scale biologic API production.

Formulation and Finished Product Manufacturers

Following API production, ZYCLARA’s formulation and final packaging are critical to ensuring stability and delivery efficacy.

• Global Contract Manufacturers: Several firms specialize in sterile injectables or specialized formulations, including:

  • Vetter Pharma International (Germany): Known for sterile filling.

  • Recipharm (Sweden): Provides formulation and fill-finish services.

  • Famar (Greece): Offers comprehensive sterile manufacturing solutions.

Distribution Partners and Logistics

The final link involves distribution channels, crucial for maintaining product integrity during transit.

• Distribution Networks: Multinational logistics providers such as DHL Supply Chain, FedEx, or UPS work closely with manufacturers to ensure cold chain integrity.

• Regional Distributors: In specific markets, regional distributors or wholesalers, such as McKesson or Cardinal Health, may handle local distribution.

Strategic Considerations and Dependency Risks

The complexity and sensitivity of ZYCLARA’s supply chain underscore several strategic risks:

• Regulatory Variability: Differences in manufacturing regulations across regions can impact supply continuity.

• Consolidation of Suppliers: Dependence on limited suppliers increases vulnerability; diversifying sources mitigates risks.

• Geopolitical Factors: Trade tensions and export restrictions, particularly involving China and India, can disrupt raw material and API flows.

• Supply Chain Transparency: Increasing regulations demand transparency, necessitating rigorous supplier audits and quality assurance procedures.

Emerging Trends and Future Outlook

To ensure sustainability, pharmaceutical firms are investing in:

• Vertical Integration: Developing in-house capabilities for critical API manufacturing and formulation.

• Diversification: Sourcing from multiple suppliers across geographical regions to hedge against disruptions.

• Technological Advancements: Employing digital supply chain management tools for real-time monitoring and optimizing supplier performance.

• Sustainable Sourcing: Aligning with environmental and social governance (ESG) standards, particularly in raw material procurement.

Conclusion

The supplier landscape for ZYCLARA encompasses a complex, globally dispersed network of raw material providers, API manufacturers, formulation specialists, and logistics companies. Strategic management of these relationships is key to maintaining supply continuity, meeting regulatory standards, and ensuring cost competitiveness. As the pharmaceutical industry evolves, so too will the supplier ecosystem, emphasizing diversification, transparency, and technological integration.

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Key Takeaways

• The success of ZYCLARA hinges on a diversified, resilient supply chain involving key suppliers across chemical, biological, and logistical domains.
• India, China, and Europe are crucial regions contributing raw materials, APIs, and formulation services for ZYCLARA.
• Contract manufacturing organizations (CMOs and CDMOs) are vital partners, offering scalable and compliant manufacturing solutions.
• Dependency risks necessitate supply chain diversification, strategic sourcing, and technology-driven monitoring.
• Future supply chain strategies will focus on sustainability, transparency, and technological adoption to mitigate global disruptions.

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FAQs

1. Who are the primary raw material suppliers for ZYCLARA?
Major raw material suppliers include Indian companies like Aurobindo Pharma and global producers from China and Europe, providing chemical intermediates and biologic inputs requisite for ZYCLARA’s synthesis and formulation.

2. Is ZYCLARA produced in-house or through external manufacturers?
The production model varies; many firms rely on contract manufacturing organizations (CMOs) and CDMOs, especially for APIs and formulation, to scale efficiently while maintaining regulatory compliance.

3. What risks are associated with ZYCLARA’s supply chain?
Risks include supply disruptions due to geopolitical tensions, regulatory changes, dependence on limited suppliers, and logistical challenges in maintaining cold chain integrity.

4. How are emerging trends influencing ZYCLARA's supply chain?
Trends such as increased diversification, digital supply chain management, and sustainability initiatives aim to enhance resilience, transparency, and environmental compliance.

5. What strategic measures can stakeholders take to ensure supply continuity for ZYCLARA?
Stakeholders should diversify supplier bases, establish long-term contracts, implement real-time supply chain monitoring, and invest in vertically integrated manufacturing capabilities when feasible.

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References

1. [1] “Global API Market Overview,” Pharmaceuticals Technology, 2022.
2. [2] “Contract Manufacturing in Biopharmaceuticals,” Evaluate Pharma, 2021.
3. [3] “Supply Chain Strategies for Biologic Drugs,” Pharmaceutical Commerce, 2022.
4. [4] “Impact of Geopolitical Tensions on Pharmaceutical Supply Chains,” WHO Reports, 2023.
5. [5] “Sustainable Sourcing in Pharma,” Healthcare Packaging, 2022.