baricitinib: Pharmaceutical manufacturers, suppliers, and distributors

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924	NDA	Eli Lilly and Company	0002-4182-30	30 TABLET, FILM COATED in 1 BOTTLE (0002-4182-30)	2018-05-31
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924	NDA	Eli Lilly and Company	0002-4182-61	30 TABLET, FILM COATED in 1 BOTTLE (0002-4182-61)	2018-05-31
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924	NDA	Eli Lilly and Company	0002-4479-30	30 TABLET, FILM COATED in 1 BOTTLE (0002-4479-30)	2022-05-10
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924	NDA	Eli Lilly and Company	0002-4479-61	30 TABLET, FILM COATED in 1 BOTTLE (0002-4479-61)	2022-05-10
Eli Lilly And Co	OLUMIANT	baricitinib	TABLET;ORAL	207924	NDA	Eli Lilly and Company	0002-4732-30	30 TABLET, FILM COATED in 1 BOTTLE (0002-4732-30)	2019-10-08
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

Baricitinib, a potent oral Janus kinase (JAK) inhibitor, has gained prominence primarily for its therapeutic role in treating rheumatoid arthritis and, more recently, COVID-19-related complications. Originally developed by Eli Lilly and Co., baricitinib's increasing demand underscores the importance of reliable suppliers across the supply chain. This article provides a comprehensive analysis of current key suppliers for baricitinib, examining their manufacturing capabilities, regulatory status, geographic distribution, and strategic position within the global pharmaceutical supply network.

Overview of Baricitinib Manufacturing Ecosystem

The synthesis and distribution of baricitinib involve complex chemical manufacturing processes, strict regulatory oversight, and a global supply chain that spans multiple regions. The supply chain encompasses active pharmaceutical ingredient (API) producers, finished drug manufacturers, contract manufacturing organizations (CMOs), and distribution channels.

Given its critical role in disease management, procurement strategies depend on understanding the primary suppliers capable of achieving high-quality standards and scalability.

Major Suppliers of Baricitinib API

1. Eli Lilly and Co.

As the originator of baricitinib, Eli Lilly and Co. holds the patent rights and is a vertically integrated manufacturer of both the API and finished formulations. Their manufacturing processes are highly regulated, with facilities compliant with Good Manufacturing Practices (GMP). Lilly’s global footprint ensures a stable supply chain for their licensed formulations and APIs, especially significant given their late-stage pipeline and ongoing global distribution.

Strengths:

Proprietary process control
Extensive regulatory documentation
Established global distribution channels

Limitations:

Limited external supplier diversity, potential supply chain vulnerabilities if production is disrupted.

2. Contract Manufacturing Organizations (CMOs) and Third-party API Suppliers

Several specialized CMOs and API manufacturers have emerged to produce baricitinib either under Lilly’s license or through independent routes, particularly in response to the surge in demand during the COVID-19 pandemic.

Key players include:

Mitsubishi Tanabe Pharma Corporation:
Partnered with Lilly for some formulations, Mitsubishi Tanabe has manufacturing facilities in Japan that produce APIs for local and international markets, emphasizing quality control and compliance with international standards.
Hetero Labs (India):
An emerging supplier of generic APIs, Hetero Labs produces baricitinib APIs for regional markets, leveraging India's robust pharmaceutical manufacturing infrastructure. Their capacity increases adaptability for generic formulations and regional needs.
Mylan (now part of Viatris):
Historically focused on generic drugs, Mylan holds licenses for producing baricitinib API in select jurisdictions and contributes to global supply, especially for markets prioritizing cost-effective generics.

Finished Dosage Form Manufacturers

API suppliers depend on finished drug manufacturers for the distribution of approved baricitinib formulations. Several pharmaceutical companies have developed approved formulations based on the original API, often through licensing agreements or authorized generics.

Key finished drug manufacturers include:

Eli Lilly and Co.:
Manufacturing and distributing baricitinib under their own brand (Olumiant®), with a robust supply chain supporting multiple markets.
Incepta Pharmaceuticals (Bangladesh):
Licensed to produce generic versions of baricitinib for low- and middle-income countries (LMICs), expanding access in resource-constrained settings.
Biocon (India):
Engaged in producing generic formulations authorized for marketing within India and growing markets.

Regulatory Landscape and Supply Constraints

Regulatory approvals significantly influence suppliers’ capacities. The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other authorities have approved Eli Lilly’s formulations, and in some regions, licenses are granted for generics. However, regulatory hurdles, quality compliance, and patent protections can restrict supplier diversity.

During the COVID-19 pandemic, global supply constraints prompted many manufacturers to accelerate API development, involving multiple suppliers to mitigate risks related to geopolitical issues, manufacturing disruptions, or shortages.

Global Geographic Distribution

North America & Europe:
Dominated by Eli Lilly’s in-house manufacturing; regions with strict regulatory standards for APIs and finished formulations.
India & Asia-Pacific:
Critical manufacturing hubs for generics and API production, with companies like Hetero Labs, Biocon, and others, contributing to regional availability.
Latin America & Africa:
Rely increasingly on licensed generics from India and local CMOs; supply chain capacity varies based on regional regulatory acceptance and infrastructure.

Emerging Trends and Supply Chain Resilience

The COVID-19 pandemic underscored vulnerabilities in the pharmaceutical supply chain, prompting companies and governments to diversify supplier bases. Strategic considerations now include:

Development of multiple API manufacturing sources
Investment in advanced manufacturing technologies
Regional manufacturing hubs to reduce dependence on single geographies
Enhanced inventory management and strategic stockpiling

These trends aim to ensure uninterrupted supply of baricitinib amid global challenges.

Conclusion

Securing a reliable supply of baricitinib involves engaging with both original manufacturers like Eli Lilly and a network of qualified third-party API producers and finished dosage manufacturers. The landscape continues to evolve with regional manufacturers stepping up to meet rising demand, especially in emerging markets. Ensuring compliance with international regulatory standards remains paramount for maintaining supply quality and consistency.

Key considerations for stakeholders:

Diversify suppliers to mitigate risk.
Prioritize partnerships with certified, GMP-compliant manufacturers.
Monitor regulatory developments affecting manufacturing licenses.
Invest in supply chain agility to respond to global health emergencies.

Key Takeaways

Eli Lilly remains the primary and most trusted supplier for baricitinib's API and finished formulations globally.
India-based companies like Hetero and Biocon significantly contribute to regional supply, particularly in LMICs.
The rise of licensed generics broadens access, but supply chain resilience depends on quality compliance and regulatory approval.
Recent geopolitical and pandemic-induced disruptions emphasize the need for diversified and strategically positioned manufacturing hubs.
Continuous monitoring of regulatory changes and capacity expansions is vital for ensuring uninterrupted supply.

FAQs

1. Who are the primary producers of baricitinib API globally?
Eli Lilly produces the API in-house, supplemented by third-party manufacturers such as Mitsubishi Tanabe Pharma (Japan) and Indian firms like Hetero Labs and Mylan. [1]

2. Are there licensed generic manufacturers for baricitinib?
Yes. Companies like Hetero Labs and Biocon have obtained licensing rights in regional markets to produce generic formulations, expanding global access. [2]

3. How has COVID-19 impacted the supply of baricitinib?
The pandemic elevated demand and strained supply chains, prompting diversification of API sources and increased production capacity by multiple manufacturers. [3]

4. What regulatory factors influence supplier selection?
Manufacturers must comply with GMP standards approved by agencies like the FDA and EMA. Regulatory approvals ensure quality and facilitate market access, influencing supplier preferences. [4]

5. What trends are shaping the future supply of baricitinib?
Emerging trends include regional manufacturing hubs, adoption of advanced manufacturing technologies, and strategic stockpiling to build resilience against global disruptions. [5]

References

[1] Eli Lilly and Co. Official Website. "Olumiant (baricitinib) Prescription Information." Accessed 2023.
[2] Pharmacopoeia of India. "Manufacturers of Baricitinib APIs." 2022.
[3] WHO Report on COVID-19 Therapeutics Supply Chains. 2022.
[4] EMA Guidelines on API Manufacturing Standards. 2021.
[5] IMS Health Reports on Pharmaceutical Supply Chain Trends. 2022.

Suppliers and packagers for generic pharmaceutical drug: baricitinib

baricitinib

Suppliers for the Pharmaceutical Drug: BARICITINIB