Share This Page
Suppliers and packagers for generic pharmaceutical drug: maraviroc
✉ Email this page to a colleague
maraviroc
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 |
| Hetero Labs Ltd Iii | MARAVIROC | maraviroc | TABLET;ORAL | 203347 | ANDA | Camber Pharmaceuticals, Inc. | 31722-579-60 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-579-60) | 2022-02-06 |
| Hetero Labs Ltd Iii | MARAVIROC | maraviroc | TABLET;ORAL | 203347 | ANDA | Camber Pharmaceuticals, Inc. | 31722-580-60 | 60 TABLET, FILM COATED in 1 BOTTLE (31722-580-60) | 2022-02-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Maraviroc
Introduction
Maraviroc, a CCR5 antagonist developed by Pfizer, is a pivotal antiretroviral drug targeting HIV-1 infection. Approved by the U.S. Food and Drug Administration (FDA) in 2007, it plays a critical role in HIV treatment regimens, especially for patients with CCR5-tropic HIV-1 strains.[1] The global supply chain for maraviroc involves multiple suppliers across the pharmaceutical industry, including active pharmaceutical ingredient (API) manufacturers, formulation producers, and distribution channels. Understanding these suppliers' landscape offers insights into drug availability, competition, and potential risks associated with supply continuity.
Manufacturers of Active Pharmaceutical Ingredient (API) for Maraviroc
Primary API Suppliers
1. Johnson Matthey (UK)
Johnson Matthey is a significant supplier of maraviroc's API, leveraging its extensive expertise in fine chemicals and pharmaceutical synthesis. The company supplies high-purity APIs to Pfizer and other manufacturers, adhering to stringent quality standards compliant with Good Manufacturing Practices (GMP). Johnson Matthey’s manufacturing facilities in the UK and the US ensure supply security and regulatory compliance.[2]
2. WuXi AppTec (China)
WuXi AppTec is a leading global contract development and manufacturing organization (CDMO) offering API synthesis services. The company has expanded its portfolio to include HIV-related APIs, including maraviroc, due to the growing demand for antiretroviral drugs. Their capabilities span from early-phase synthesis to large-scale production, supporting global pharmaceutical companies.[3]
3. Cambrex (USA)
Cambrex specializes in small-molecule APIs and intermediates for the pharmaceutical industry. With facilities in the US and Europe, Cambrex has the capacity to supply maraviroc API, leveraging its expertise in complex syntheses and compliance with international quality standards.[4]
Emerging and Contract Manufacturers
In addition to established players, several CDMOs and emerging manufacturers have shown interest in producing maraviroc APIs, primarily driven by increased demand for HIV therapeutics in emerging markets. These firms often secure manufacturing licenses or collaborate with Pfizer under licensing agreements to ensure an adequate supply flow.
Formulation and Finished Dosage Form Suppliers
Once the API is produced, it transitions to formulation and packaging firms for final drug product manufacturing.
Major Formulation and Packaging Providers
Pfizer Inc.
As the originator of maraviroc, Pfizer maintains in-house manufacturing capabilities for final drug formulations at several facilities globally. Pfizer ensures quality control, regulatory compliance, and adequate supply of maraviroc-containing products, including branded and generic versions.[5]
Contract Manufacturing Organizations (CMOs)
Additionally, Pfizer partners with CMOs across North America, Europe, and Asia to meet global demand. These CMOs handle formulation, tablet compression, capsule filling, and packaging, adhering strictly to GMP standards.
Distribution and Supply Chain
Post-manufacturing, maraviroc products are distributed worldwide through Pfizer's extensive logistics network and authorized wholesalers. The global HIV treatment market's growth has amplified the need for resilient supply chains, especially in low- and middle-income countries facing challenges in medicine access.
Regulatory Aspects Influencing Suppliers
The supply chain's stability hinges on compliance with regulatory standards set by agencies like the FDA, EMA, and China's NMPA. Suppliers maintaining GMP accreditation, high-quality raw materials, and robust manufacturing processes are positioned favorably. Pfizer's regulatory approvals and ongoing quality audits govern the operational scope of these suppliers.
Competitive Landscape and Risks
The concentration of API production within a handful of large players introduces potential risks, including supply disruptions due to geopolitical issues, regulatory non-compliance, or raw material shortages. Recent trends indicate a move towards diversifying API sourcing to mitigate these risks, often through partnerships with regional manufacturers in India and China.
Emerging Trends in the Supplier Ecosystem
- Shift towards regional manufacturing: Countries like India and China are expanding their API production capacity, supported by government initiatives and technological investments, to reduce dependency on Western firms and enhance supply resilience.[6]
- Integration of digital technologies: Suppliers employ digital quality management and supply chain tracking to improve transparency and compliance.
- Focus on sustainable manufacturing: Environmental concerns drive investments in greener synthesis routes and waste reduction in API production.
Conclusion
The supply ecosystem for maraviroc comprises a mix of established global pharmaceutical suppliers, large contract manufacturing organizations, and emerging regional manufacturers. Ensuring supply continuity depends on effective collaboration among Pfizer, API producers, and formulators, all maintaining high regulatory and quality standards. While current suppliers like Johnson Matthey, WuXi AppTec, and Cambrex dominate, the landscape is evolving toward diversification to minimize risks and meet global demand effectively.
Key Takeaways
- Major API suppliers for maraviroc include Johnson Matthey, WuXi AppTec, and Cambrex, each offering high-quality, GMP-compliant production.
- The primary formulations are produced predominantly by Pfizer facilities, supplemented by contract manufacturing organizations worldwide.
- Regional manufacturing hubs in India and China are expanding their roles, aiming to diversify the supply chain and enhance resilience.
- Regulatory compliance and sustainable manufacturing practices are critical factors influencing supplier credibility and stability.
- Supply chain risks necessitate ongoing diversification and strategic partnerships to ensure uninterrupted access to maraviroc.
FAQs
1. Who are the main manufacturers of maraviroc API globally?
Johnson Matthey, WuXi AppTec, and Cambrex are primary API suppliers, leveraging extensive GMP-compliant manufacturing capacities to serve global needs.
2. How does Pfizer ensure a steady supply of maraviroc?
Pfizer utilizes in-house manufacturing facilities complemented by partnerships with established CDMOs, maintaining strict quality controls and regulatory compliance.
3. Are there regional manufacturers supplementing the global supply of maraviroc?
Yes, manufacturers in India and China are increasingly involved, supported by government initiatives aimed at expanding API production capabilities.
4. What are the risks associated with the current maraviroc supply chain?
Risks include dependency on limited API producers, geopolitical tensions, raw material shortages, and regulatory non-compliance, which could disrupt supply.
5. How is the supply chain for maraviroc adapting to market changes?
The industry is shifting towards regional manufacturing expansion, technological integration, and sustainability initiatives to improve resilience and meet growing demand.
References
[1] U.S. Food and Drug Administration. Maraviroc (Selzentry) drug approval information. Retrieved from FDA archives.
[2] Johnson Matthey. Annual Report 2022.
[3] WuXi AppTec. Capabilities in API manufacturing.
[4] Cambrex. Small Molecule API Portfolio.
[5] Pfizer. Maraviroc manufacturing and distribution updates.
[6] World Health Organization. Global API manufacturing landscape.
More… ↓
