Suppliers and packagers for selzentry

selzentry

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viiv Hlthcare	SELZENTRY	maraviroc	SOLUTION;ORAL	208984	NDA	ViiV Healthcare Company	49702-260-55	1 KIT in 1 CARTON (49702-260-55) * 230 mL in 1 BOTTLE	2020-10-30
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128	NDA	ViiV Healthcare Company	49702-223-18	60 TABLET, FILM COATED in 1 BOTTLE (49702-223-18)	2011-05-16
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128	NDA	ViiV Healthcare Company	49702-224-18	60 TABLET, FILM COATED in 1 BOTTLE (49702-224-18)	2011-05-16
Viiv Hlthcare	SELZENTRY	maraviroc	TABLET;ORAL	022128	NDA	A-S Medication Solutions	50090-6238-0	60 TABLET, FILM COATED in 1 BOTTLE (50090-6238-0)	2011-05-16

Suppliers for the Pharmaceutical Drug: Selzentry

Last updated: July 30, 2025

Introduction

Selzentry (maraviroc) is an antiretroviral medication developed by Pfizer, primarily utilized for treating HIV-1 infection in treatment-experienced or antiviral-resistant patients. As a CCR5 antagonist, Selzentry binds specifically to the CCR5 receptor, preventing HIV from entering host cells. The drug’s global distribution relies heavily on a complex network of suppliers across various stages, including active pharmaceutical ingredient (API) manufacturing, formulation, packaging, and distribution. Ensuring supply chain integrity is critical for maintaining accessibility, pricing stability, and regulatory compliance. This report examines the key suppliers involved in each stage of Selzentry’s lifecycle, providing insights into market dynamics, sourcing strategies, and competitive landscape.

API Manufacturing

Pfizer’s In-house Production

Pfizer retains control over much of the API manufacturing for Selzentry, leveraging its global manufacturing facilities. The company operates multiple manufacturing plants, notably in North America and Europe, to ensure supply security. Pfizer’s vertically integrated approach allows better oversight of quality and compliance, minimizing risks associated with third-party dependencies.

Third-Party API Suppliers

Despite Pfizer’s in-house capabilities, several third-party manufacturers supply raw materials and intermediates essential for Selzentry production. Notable API suppliers include:

• Hallstar Biocare (India): Known for producing high-quality intermediates, including the chemical compounds required for maraviroc synthesis.
• Fareva (France): Provides contract manufacturing services for active ingredients, including complex APIs.
• APIs Europe: A key player in bulk API supply, offering cost-effective, high-quality APIs originating primarily from India and China.

Challengers and Market Entrants

India and China dominate the API supply landscape for HIV drugs, driven by lower manufacturing costs and expanding production capacities. Major API manufacturers from these regions include:

• Cipla (India): A global generic manufacturer with capabilities in HIV APIs.
• Sun Pharma (India): Works as an API supplier for various antiretrovirals, including maraviroc intermediates.
• Zhejiang Huahai Pharmaceutical (China): A significant player in API manufacturing, capable of supplying numerous HIV drug APIs.

Supply Risks & Regulatory Considerations: Relying on international suppliers introduces risks such as regulatory discrepancies, quality assurance challenges, and geopolitical factors affecting supply stability.

Formulation and Final Dosage Form Manufacturing

Contract Manufacturing Organizations (CMOs)

Pfizer partners with various CMOs for formulation, tablet compression, and final product packaging to meet global demand:

• Vetter Pharma (Germany): Provides aseptic fill-finish services, ensuring sterile injectables if applicable.
• Haw Par Healthcare (Singapore): Responsible for manufacturing and packaging in specific regional markets.

Regional Market Supply

In the United States, Pfizer’s own manufacturing facilities produce Selzentry tablets, ensuring compliance with FDA standards. In other regions such as Europe and Asia, local CMOs or Pfizer subsidiaries handle production, with regional suppliers ensuring rapid distribution.

Distribution and Logistics Suppliers

Ensuring uninterrupted supply requires efficient logistics providers:

• DHL Supply Chain: Global leader in pharmaceutical logistics, managing temperature-controlled transportation.
• FedEx and UPS: Key players facilitating regional and international distribution.
• Specialized Cold Chain Providers: For sensitive components, temperature monitoring is crucial.

Supply Chain Challenges and Strategies

Intellectual Property and Patent Considerations

Selzentry’s patent exclusivity has historically limited generic competition, but patent expirations in certain jurisdictions open market opportunities. Suppliers need to ensure compliance with patent laws, as infringing manufacturing could lead to legal disputes.

Quality Assurance and Regulatory Compliance

Suppliers must adhere to Good Manufacturing Practices (GMP) and obtain requisite approvals from agencies such as the FDA, EMA, and PMDA. Pfizer conducts rigorous audits and quality assessments before onboarding suppliers.

Supply Chain Diversification

To mitigate risks, Pfizer and other stakeholders diversify sources across regions and manufacturers. Building redundancy minimizes vulnerabilities posed by geopolitical tensions, natural disasters, and supply chain disruptions, exemplified recently by COVID-19-induced bottlenecks.

Emerging Suppliers and Market Trends

Biotech and Contract Manufacturing Growth

Emerging biotech companies are exploring novel manufacturing technologies, including continuous manufacturing processes, potentially reducing costs and lead times.

Regional Manufacturing Initiatives

China and India are investing in bioequivalent production facilities, aiming for self-sufficiency that will influence future Selzentry supply chain configurations.

Sustainability and Green Chemistry

Increasing focus on sustainable sourcing is prompting suppliers to adopt greener practices, aligning with corporate social responsibility goals and regulatory expectations.

Conclusion

The supply ecosystem for Selzentry comprises a sophisticated network of in-house manufacturing, third-party API suppliers, CMOs for formulation, and logistics providers. Key API suppliers in India and China, along with Pfizer’s own manufacturing assets, anchor the supply chain, while regional CMOs and logistics firms ensure delivery. The evolving geopolitical landscape, patent statuses, and regulatory frameworks influence sourcing strategies. Diversification and quality assurance remain paramount to sustain uninterrupted supply, essential for maintaining access for HIV patients worldwide.

Key Takeaways

• Global API sourcing primarily involves manufacturers from India and China, necessitating robust regulatory oversight.
• Pfizer’s vertically integrated approach enhances control over manufacturing and quality but depends on diversified third-party APIs.
• Supply chain risks include geopolitical tensions, regulatory changes, and disruptions amplified by the COVID-19 pandemic.
• Regional manufacturing and logistics providers enhance distribution efficiency and responsiveness.
• Sustainable manufacturing practices and technological innovations are shaping future supplier relationships, potentially reducing costs and improving supply resilience.

Frequently Asked Questions (FAQs)

1. Who are the primary API suppliers for Selzentry?
Major API suppliers include Indian companies like Cipla and Sun Pharma, along with Chinese manufacturers such as Zhejiang Huahai Pharmaceutical. Pfizer also produces API internally at its manufacturing facilities.

2. How does Pfizer ensure the quality of suppliers for Selzentry?
Pfizer conducts comprehensive audits, enforces strict GMP compliance, and requires regulatory approvals from suppliers before onboarding, ensuring high-quality standards.

3. Are there concerns about supply chain disruptions for Selzentry?
Yes, reliance on international suppliers and geopolitical tensions pose risks. Pfizer mitigates these through supplier diversification, regional manufacturing, and strategic inventory management.

4. What trends are influencing Selzentry’s future supply chain?
Emerging biotech manufacturing methods, regional production investments, and sustainability initiatives are reshaping how suppliers are selected and managed.

5. Will patent expirations impact Selzentry supply?
Potential patent expirations in some regions could lead to increased generic production, expanding supplier options and possibly affecting market pricing and supply dynamics.

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Sources

1. Pfizer Inc. (2022). Selzentry (maraviroc) Prescribing Information.
2. U.S. Food and Drug Administration (FDA). Approved Drug Products with Therapeutic Equivalence Evaluations.
3. IQVIA (2021). Global API Market Analysis.
4. World Health Organization. (2020). Standards for Quality Assurance in Active Pharmaceutical Ingredient Manufacturing.
5. Statista. (2022). Global Pharmaceutical Logistics Market Revenue.