Suppliers and packagers for cibinqo

cibinqo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0235-30	30 TABLET, FILM COATED in 1 BOTTLE (0069-0235-30)	2022-02-24
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0335-30	30 TABLET, FILM COATED in 1 BOTTLE (0069-0335-30)	2022-02-24
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0435-30	30 TABLET, FILM COATED in 1 BOTTLE (0069-0435-30)	2022-02-24
Pfizer	CIBINQO	abrocitinib	TABLET;ORAL	213871	NDA	U.S. Pharmaceuticals	63539-236-14	14 TABLET, FILM COATED in 1 BOTTLE (63539-236-14)	2022-02-24

Suppliers for the Pharmaceutical Drug: CIBINQO

Last updated: July 28, 2025

Introduction

CIBINQO (abrocitinib) is an oral Janus kinase 1 (JAK1) inhibitor marketed by Pfizer, primarily indicated for the treatment of moderate to severe atopic dermatitis in adults. As a novel pharmaceutical entity, its manufacturing and distribution involve a complex ecosystem of suppliers across multiple stages—ranging from active pharmaceutical ingredient (API) production to finished dosage form manufacture and packaging. Understanding these suppliers offers vital insights into the drug’s supply chain resilience, cost structure, and potential risks.

CIBINQO’s Manufacturing Ecosystem: An Overview

CIBINQO’s supply chain traces back to high-quality API production, a critical step affecting efficacy, safety, and regulatory compliance. Finished drug products undergo rigorous quality control, packaging, and distribution, often involving multiple third-party vendors. Since Pfizer is the sole marketing authorization holder, the company coordinates or directly oversees key suppliers to ensure supply stability. However, the globalized nature of pharmaceutical manufacturing implies engagement with numerous suppliers across regions.

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Active Pharmaceutical Ingredient (API) Suppliers

The cornerstone of CIBINQO’s manufacturing is the procurement of high-purity API, abrocitinib. Given the centralized nature of JAK inhibitor production, APIs are typically sourced from specialized manufacturers with robust quality assurance (QA) protocols.

API Manufacturers:

• Symbiosis Pharmaceutical Services:
  While not confirmed as the exclusive API supplier for abrocitinib, some market sources suggest Symbiosis provides APIs for similar small molecule drugs. Their capabilities include complex synthesis and strict compliance with Good Manufacturing Practice (GMP) standards.

• WuXi AppTec:
  As a leading contract development and manufacturing organization (CDMO), WuXi AppTec has the capacity to synthesize and supply APIs for a broad spectrum of drugs, including JAK inhibitors. Pfizer could leverage WuXi’s extensive network of manufacturing facilities to supplement API sourcing, especially amid global supply constraints.

• Selvita or Dr. Reddy’s Laboratories:
  These organizations are known for GMP API production and could potentially serve as API suppliers or contract manufacturers (CMOs) for abrocitinib, given their experience in kinase inhibitors.

Supply Chain Considerations for APIs:

• Geographical Risks:
  APIs are often sourced from Asia, notably China and India, due to cost efficiency and manufacturing scale. However, recent geopolitical and supply chain disruptions necessitate diversification strategies.

• Regulatory Compliance:
  Suppliers must meet stringent regulatory standards (e.g., FDA, EMA) to evade delays or rejections in global markets.

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Formulation and Finished Product Manufacturing

Post-API synthesis, the production process involves formulation, tablet compression, coating, and packaging. Although Pfizer manages the commercial supply chain, it likely partners with specialized CMOs for these functions.

Potential Contract Manufacturers (CMOs):

• Lonza:
  Recognized globally for pharmaceuticals and biotech manufacturing, Lonza provides formulation, fill-finish, and packaging services—possibly engaged in CIBINQO’s production.

• Catalent:
  Specializing in drug development and manufacturing, Catalent offers capabilities for oral solid dosage forms, which could include CIBINQO’s tablets, providing enhanced supply flexibility.

• Recipharm:
  A European CMO with extensive experience in commercial-scale manufacturing of oral drugs, Recipharm might be involved in CIBINQO’s production, especially for European markets.

Packaging and Distribution:

Suppliers involved in packaging often include companies like Gerresheimer or West Pharmaceutical Services, which supply primary packaging components such as blisters, bottles, and closures. These supply activities are critical for maintaining drug stability and tamper evidence.

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Supply Chain Risks and Mitigation Strategies

Given the complexity of pharmaceutical supply chains, potential risks include:

• Raw Material Shortages:
  Bottlenecks in API or excipient production can delay manufacturing.

• Regulatory Delays:
  Variations in compliance standards among suppliers may lead to approval hurdles.

• Geopolitical and Pandemic Disruptions:
  COVID-19 highlighted vulnerabilities in Asia-based supply chains; diversification remains imperative.

Mitigation Approaches:

• Strengthening supplier qualification processes
• Establishing dual sourcing arrangements
• Building inventory buffers for critical raw materials
• Engaging in long-term supply agreements to secure capacity

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Key Considerations for Stakeholders

• Supply Chain Transparency:
  Transparency regarding suppliers enables proactive risk management and bolsters regulatory confidence.

• Quality Assurance:
  Ensuring suppliers meet GMP standards is paramount, especially given the tight regulatory environment for immunomodulators like JAK inhibitors.

• Strategic Diversification:
  Diversifying suppliers geographically reduces dependence and mitigates geopolitical or localized disruptions.

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Key Takeaways

• API Sourcing:
  Pfizer’s production of abrocitinib likely involves contracted suppliers with GMP-certified facilities, possibly including WuXi AppTec, Selvita, or Reddy’s Laboratories. These suppliers are vital cogs in the supply chain's integrity.

• Manufacturing Partnerships:
  Contract manufacturers like Lonza, Catalent, or Recipharm probably handle formulation, packaging, and final dosage production, ensuring scalability and compliance.

• Supply Chain Risks:
  Raw material shortages, geopolitical issues, and pandemic impacts remain notable concerns, prompting the need for strategic diversification and inventory management.

• Regulatory and Quality Vigilance:
  Suppliers must adhere strictly to regulations to prevent delays or recalls, emphasizing robust QA protocols.

• Business Implication:
  Securing diversified, transparent, and compliant supplier relationships enhances product availability and supports Pfizer’s market position for CIBINQO.

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FAQs

1. Who are the primary API suppliers for CIBINQO?
Pfizer’s primary API suppliers likely include large, GMP-certified contract manufacturers such as WuXi AppTec and possibly Reddy’s Laboratories, which have the capacity to produce kinase inhibitors like abrocitinib.

2. Are there any exclusive suppliers for CIBINQO’s manufacturing process?
No publicly available information confirms exclusive suppliers. Likely, Pfizer employs multiple qualified vendors to mitigate supply risks.

3. How does supply chain diversification impact CIBINQO’s market stability?
Diversification spreads risk, ensuring consistent supply despite geopolitical or pandemic-related disruptions, thus safeguarding market availability and revenue streams.

4. What role do CMOs play in CIBINQO’s commercial production?
CMOs handle formulation, filling, packing, and distribution processes, enabling Pfizer to scale production efficiently while maintaining compliance.

5. What future supply chain challenges could affect CIBINQO?
Potential challenges include raw material shortages, regulatory changes, increased manufacturing costs, and geopolitical instability, necessitating continuous supply chain monitoring and strategic planning.

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Sources

1. Pfizer Inc. (2022). CIBINQO (abrocitinib) prescribing information.
2. EvaluatePharma, Global Pharmaceutical Contract Manufacturing Market.
3. WuXi AppTec Corporate Overview.
4. Lonza Group Annual Report.
5. Regulatory filings and industry reports on pharmaceutical supply chain management.