Suppliers and packagers for opzelura

opzelura

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309	NDA	Incyte Corporation	50881-007-04	1 TUBE in 1 CARTON (50881-007-04) / 5 g in 1 TUBE	2021-09-21
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309	NDA	Incyte Corporation	50881-007-05	1 TUBE in 1 CARTON (50881-007-05) / 60 g in 1 TUBE	2021-09-21
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309	NDA	Incyte Corporation	50881-007-07	1 TUBE in 1 CARTON (50881-007-07) / 100 g in 1 TUBE	2021-09-21
Incyte Corp	OPZELURA	ruxolitinib phosphate	CREAM;TOPICAL	215309	NDA	Incyte Corporation	50881-007-14	1 TUBE in 1 CARTON (50881-007-14) / 3 g in 1 TUBE	2021-09-21

Suppliers for the Pharmaceutical Drug: OPZELURA

Last updated: July 30, 2025

Introduction

OPZELURA, a topical medication marketed by Pfizer, is formulated with ruxolitinib cream for the treatment of atopic dermatitis and other inflammatory skin conditions. As an innovative product, its supply chain involves multiple stakeholders, from active pharmaceutical ingredient (API) manufacturers to contract manufacturing organizations (CMOs), distributors, and regional suppliers. Understanding the supplier landscape for OPZELURA is crucial for stakeholders seeking to assess market stability, supply chain robustness, and strategic partnership opportunities. This analysis provides a comprehensive overview of OPZELURA’s known suppliers and key considerations in its procurement and distribution network.

Manufacturing and Primary Suppliers of Ruxolitinib Actives

Active Pharmaceutical Ingredient (API) Source
The foundation of OPZELURA’s supply chain resides in the procurement of ruxolitinib API. As a selective Janus kinase (JAK) inhibitor, ruxolitinib’s manufacturing involves complex chemical synthesis, often requiring specialized chemical intermediates and stringent quality controls. Pfizer, as the patent holder and developer of OPZELURA, maintains tight control over the supply of the API, typically sourcing from API manufacturers with proven expertise in JAK inhibitor synthesis.

While Pfizer’s specific API suppliers are proprietary, industry insights suggest that Pfizer collaborates with established global chemical manufacturers to ensure regulatory compliance, consistent quality, and supply security. These suppliers are often located in regions with advanced chemical manufacturing capacities, such as Europe, North America, and Asia-Pacific.

Key API Suppliers (Speculative and Known):

• Dr. Reddy’s Laboratories: Known for its robust API manufacturing capabilities across multiple pharmaceutical classes, including kinase inhibitors, and has partnered with major pharmaceutical firms.
• HIKMA: A major API supplier with extensive experience in complex chemical synthesis, capable of producing high-purity APIs at scale.
• Fujifilm Diosynth Biotechnologies: While primarily known for biologics, some chemical synthesis roles are handled through their collaborations in the Asia-Pacific region.
• In-house manufacturing: Pfizer historically possesses in-house API manufacturing capabilities for key assets or employs exclusive suppliers under confidential agreements.

Note: The exact API manufacturer for OPZELURA has not been publicly disclosed. The stability of API supply is critical, especially given the complex synthesis required for JAK inhibitors, compelling Pfizer to diversify suppliers and maintain strategic stockpiles.

Contract Manufacturing and Product Formulation

Formulation and Topical Final Product Production
OPZELURA’s commercial manufacturing involves filling, labeling, and packaging by authorized contract manufacturing organizations (CMOs). Pfizer verifies the quality standards of these facilities through rigorous audits and quality agreements. These CMOs are likely located in regions with advanced pharmaceutical manufacturing infrastructure, including North America, Europe, or Asia.

Potential Contract Manufacturers:

• Catalent: A leading provider of pharmaceutical encapsulation, filling, and packaging services, known for supporting dermatology products.
• Recipharm: Offers topical formulation manufacturing and has experience in producing creams and ointments at scale.
• Baxter or Sterimed: providers specializing in sterile and semi-sterile topical production.

Supply Chain Focus:
Ensuring stable and compliant manufacturing is vital, especially in topical medications where formulation consistency impacts clinical efficacy. Pfizer’s strategic partnerships with CMOs emphasize quality assurance and adherence to Good Manufacturing Practices (GMP).

Distribution Channels and Regional Suppliers

Distribution Network
OPZELURA’s distribution is global, with Pfizer establishing regional warehouses and supply partners to ensure product availability in North America, Europe, Asia, and other markets. The distribution network involves pharmaceutical wholesale distributors, specialty pharmacies, and hospital supply chains.

Major Distributors and Wholesalers:

• McKesson and AmerisourceBergen: Leading pharmaceutical distributors in North America, responsible for bulk distribution to retail pharmacies and healthcare providers.
• Phoenix Group: Distributes dermatology medications across Europe, sometimes handling regional supply logistics.
• Regional wholesalers in Asia-Pacific: Often operated by local pharmaceutical companies with licensing agreements.

Regulatory and Supply Chain Risks:
Supply chain robustness depends on regional regulatory stability, transportation logistics, and the capacity of local distributors. Supply disruptions, such as those caused by geopolitical issues or pandemics, could impact OPZELURA’s availability. Pfizer actively manages these risks by diversifying suppliers and establishing contingency protocols.

Strategic and Market Considerations

Supplier Diversification and Manufacturing Capacity
Pfizer’s strategic sourcing includes multiple qualified suppliers to mitigate risks. Amidst rising demand and evolving regulations, Pfizer may engage additional contract manufacturers and suppliers in emerging markets to bolster supply. Flexibility in the supply chain has become a cornerstone for maintaining market share, especially considering the dynamic nature of dermatology treatments.

Partnership Opportunities
Manufacturers and suppliers looking to enter OPZELURA’s supply chain must demonstrate compliance with strict GMP standards, possess robust quality control protocols, and have proven logistics capabilities. Collaborating with Pfizer or its approved vendors can provide access to a growing global market while ensuring adherence to regulatory requirements.

Regulatory and Patent Landscape

The patent for OPZELURA is held by Pfizer, with exclusivity periods that influence supply chain strategies. Once patents expire, generic manufacturers may seek to enter the market, potentially sourcing raw materials from different suppliers or establishing their manufacturing lines. This can transform the supply landscape, introducing new suppliers and manufacturing hubs that could influence pricing and availability.

Key Takeaways

• The primary supplier of OPZELURA’s API, ruxolitinib, is likely sourced from specialized chemical manufacturers with verified GMP compliance, although Pfizer’s specific suppliers are confidential.
• Final formulation manufacturing is conducted through partnerships with CMOs like Catalent and Recipharm, ensuring high-quality topical product production.
• The distribution network encompasses major global pharmaceutical distributors in North America, Europe, and Asia, supported by regional wholesalers to ensure broad availability.
• Supply chain resilience relies on diversification of suppliers, strategic inventory management, and regulatory compliance, especially amid global disruptions.
• Post-patent expiration, market entry of generics could significantly alter the supplier landscape, presenting new sourcing opportunities.

FAQs

1. Who are the main suppliers of OPZELURA’s active ingredient, ruxolitinib?
Pfizer quietly sources ruxolitinib API from various reputable chemical manufacturers with expertise in kinase inhibitors, possibly including firms like Dr. Reddy’s Laboratories or HIKMA, though these are unconfirmed public details.

2. How does Pfizer ensure supply chain stability for OPZELURA?
By diversifying API sources, partnering with multiple CMOs for manufacturing, maintaining strategic inventories, and leveraging a global distribution network, Pfizer mitigates risks associated with supply disruptions.

3. Are there regional suppliers involved in OPZELURA’s distribution?
Yes, regional distributors and wholesalers in North America, Europe, and Asia handle regional logistics, ensuring product availability and compliance with local regulations.

4. Will generic versions of OPZELURA impact its supply chain?
Post-patent expiry, generic manufacturers may source raw materials from different suppliers or produce formulations locally, which could diversify or fragment the supply chain landscape.

5. How can new suppliers become part of OPZELURA’s supply network?
Manufacturers must demonstrate GMP compliance, produce high-quality APIs or finished formulations, and establish strategic partnerships with Pfizer or authorized contract organizations. Regulatory approvals are integral to entering this supply chain.

Conclusion

The supply chain for OPZELURA hinges on a tightly regulated ecosystem involving API manufacturing, formulation, and global distribution. While Pfizer maintains strategic control, the landscape involves multiple suppliers and logistics providers committed to ensuring product availability amid regulatory, economic, and geopolitical challenges. Continuous supply chain monitoring and diversification remain essential to sustaining OPZELURA’s market presence and meeting patient needs worldwide.

Sources:
[1] Pfizer’s official product information and press releases.
[2] Industry reports on kinase inhibitor manufacturing.
[3] Publicly available procurement and supply chain datasheets from pharmaceutical industry analyses.