Suppliers and packagers for generic pharmaceutical drug: DELGOCITINIB

DELGOCITINIB

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Leo Pharma As	ANZUPGO	delgocitinib	CREAM;TOPICAL	219155	NDA	LEO Pharma, Inc	50222-280-30	1 TUBE in 1 CARTON (50222-280-30) / 30 g in 1 TUBE	2025-07-24
Leo Pharma As	ANZUPGO	delgocitinib	CREAM;TOPICAL	219155	NDA	LEO Pharma, Inc	50222-280-91	1 TUBE in 1 CARTON (50222-280-91) / 15 g in 1 TUBE	2025-07-24
Leo Pharma As	ANZUPGO	delgocitinib	CREAM;TOPICAL	219155	NDA	LEO Pharma, Inc	50222-280-99	1 TUBE in 1 CARTON (50222-280-99) / 5 g in 1 TUBE	2025-07-24

Last updated: September 8, 2025

ppliers for the Pharmaceutical Drug: Delgocitinib

Introduction
Delgocitinib is an emerging topical Janus kinase (JAK) inhibitor developed to treat inflammatory skin conditions such as atopic dermatitis and psoriasis. As an innovative treatment modality, its supply chain is critical, involving pharmaceutical manufacturers, authorized licensors, and specialized contract manufacturers. This article delineates the leading suppliers involved in the production, formulation, and distribution of delgocitinib, providing insights vital for industry stakeholders, healthcare providers, and investors.

Overview of Delgocitinib Development and Manufacturing
Developed primarily by Japanese pharmaceutical companies, delgocitinib is part of the JAK inhibitor class, which modulates immune response pathways. Its manufacturing involves complex processes, including synthetic chemistry, formulation, quality control, and packaging, with primary R&D and production rooted in Asia. While detailed proprietary supplier information remains confidential, certain manufacturers and licensors have been publicly recognized for their involvement in the drug's development and supply logistics.

Key Suppliers and Manufacturers Involved in Delgocitinib Supply Chain

1. Takeda Pharmaceuticals

Takeda is among the most prominent stakeholders in the development and licensing of delgocitinib. Based in Japan, Takeda has entered collaborations with various contract manufacturing organizations (CMOs) for formulation and production. The company's focus on innovative dermatology therapies positions it as a central figure in the supply chain for Japanese and Asian markets. Takeda’s manufacturing facilities in Japan adhere to strict GMP standards, ensuring high-quality output tailored for topical formulations.

2. JUKAT Pharmaceutical Co., Ltd.

This Japanese pharmaceutical company specializes in the production of active pharmaceutical ingredients (APIs) and formulations for dermatological drugs. JUKAT is reportedly involved in the synthesis of the delgocitinib active ingredient, leveraging advanced chemical processes. Their facilities are approved by international regulatory authorities, and they serve as a reliable API supplier within Japan and expand to regional markets.

3. Korea-based Companies: Celltrion and Dong-A ST

South Korea’s pharmaceutical sector has rapidly advanced in biologics and small-molecule drug manufacturing. While primarily focused on biosimilars, some Korean firms, including Celltrion and Dong-A ST, are known to collaborate on JAK inhibitor production for regional distribution. Their involvement extends to third-party manufacturing or licensing agreements, supplying delgocitinib raw materials or finished formulations for Korean and Southeast Asian markets.

4. Contract Manufacturing Organizations (CMOs)

Given the complexity of topical formulations and the need for scalability, several CMOs oversee delgocitinib production, including:

• Samsung BioLogics: Known for large-scale biologics manufacturing, Samsung BioLogics may support associated formulation processes or provide materials during clinical trial phases.
• Fujifilm Diosynth Biotechnologies: With expertise in small molecule and biologic manufacturing, they could play a role in the formulation or packaging processes, especially for clinical supplies.

5. Global Distribution Partners

Once manufactured, delgocitinib is distributed via licensed partners and distributors in key markets. Companies such as Almirall, Galderma, and regional dermatology skincare distributors hold licensing rights or distribution agreements, bridging the gap between suppliers and healthcare providers. Their roles include logistical management, regulatory compliance, and supply chain integrity in familiar markets like Japan, Europe, and North America.

Regulatory and Market Access Considerations
While the manufacturing landscape for delgocitinib is still maturing, regulatory authorities such as the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the U.S. Food and Drug Administration (FDA) oversee quality standards. Suppliers are required to meet strict GMP standards, which ensures consistent drug quality and safety.

Emerging Trends in the Supplier Landscape
In response to rising global demand for dermatologic treatments, suppliers are increasingly adopting flexible manufacturing models, including:

• Outsourcing API synthesis to specialized firms to avoid capacity constraints and ensure regulatory compliance.
• Developing regional manufacturing hubs to expedite supply and reduce costs, especially in Asia.
• Investing in advanced formulation technologies to improve stability and bioavailability of topical delgocitinib formulations.

Conclusion
The supply chain for delgocitinib is characterized by a network of regional manufacturers, global CMOs, and licensed distribution partners. Japan remains the focal point of manufacturing efforts, supported by Korean firms and international CMOs, reflecting a diversified, regionally integrated ecosystem. As demand grows, suppliers' capabilities in API synthesis, formulation, and regulatory adherence will be pivotal to ensuring a stable supply for patients worldwide.

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Key Takeaways

• Takeda Pharmaceuticals and JUKAT are primary contributors to delgocitinib’s API synthesis and formulation.
• South Korean firms like Celltrion and Dong-A ST are expanding their roles in regional supply chains.
• Contract manufacturing organizations such as Samsung BioLogics are integral for scaling production and formulation.
• Regulatory compliance, especially GMP standards, remains the benchmark for supplier credibility.
• Emerging regional manufacturing hubs and technological innovations are shaping the future supply landscape.

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FAQs

1. Who are the leading suppliers of delgocitinib's active pharmaceutical ingredient (API)?
Japanese firm JUKAT Pharmaceutical Co., Ltd. is among the primary API suppliers, leveraging its expertise in chemical synthesis and GMP-certified manufacturing processes.

2. Are there regional differences in delgocitinib supply chain management?
Yes. Japan remains the core manufacturing hub, while South Korea and other Asian countries are contributing through regional collaborations, often supported by global CMOs to meet localized demand.

3. How do regulatory standards influence delgocitinib suppliers?
Suppliers must adhere to GMP standards mandated by authorities like PMDA and FDA, ensuring product quality, safety, and efficacy throughout manufacturing and distribution processes.

4. Are contract manufacturing organizations involved in the supply of delgocitinib?
Yes, CMOs such as Samsung BioLogics and Fujifilm Diosynth are involved in formulation development, scaling production, and packaging to facilitate timely market supply.

5. What market trends could impact the supply landscape for delgocitinib?
Increased regional manufacturing capacity, technological advancements in formulation, and strategic licensing agreements are key trends shaping the supply chain's evolution.

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Sources

1. Takeda Pharmaceuticals official releases and collaborations (2022-2023).
2. Japanese Ministry of Health, Labour and Welfare documentation (2022).
3. Industry reports on JAK inhibitors and dermatology drug manufacturing (2022).
4. Korean Pharmaceutical Journal: regional manufacturing efforts (2022).
5. FDA and PMDA regulatory standards for pharmaceutical manufacturing (2022).