Suppliers and packagers for OLUMIANT

OLUMIANT

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

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

Suppliers for the Pharmaceutical Drug: OLUMIANT

Last updated: August 2, 2025

Introduction

OLUMIANT (baricitinib) is a prescription medication developed and marketed by Eli Lilly and Company for the treatment of rheumatoid arthritis and other inflammatory conditions. As a Janus kinase (JAK) inhibitor, OLUMIANT's manufacturing involves complex chemical synthesis, bioprocessing, and stringent quality controls. This article explores the key suppliers involved in OLUMIANT’s supply chain, examining their roles in active pharmaceutical ingredient (API) production, formulation, packaging, and distribution. The reliability and strategic partnerships of these suppliers are critical to maintaining OLUMIANT’s global availability, compliance with regulatory standards, and cost efficiency.

API Suppliers of Baricitinib

The core component of OLUMIANT is the active pharmaceutical ingredient, baricitinib. Eli Lilly relies on specialized chemical manufacturers globally to produce high-purity API at scale. These suppliers must meet rigorous cGMP (current Good Manufacturing Practice) standards, ensure consistent API quality, and satisfy regulatory approvals.

1. Liomont (Mexico)

Liomont has been a significant player in the manufacture of baricitinib, especially during the drug’s initial market launch. The company is equipped with advanced synthesis capabilities and cGMP-compliant facilities, producing API at large scales for distribution in North America and Latin America. Liomont’s role underscores Lilly’s strategy to diversify API sourcing and reduce geopolitical risks.

2. Deva Pharmachem (India)

Deva Pharmachem, based in India, has supplied baricitinib API to Lilly, leveraging India’s extensive generic pharmaceutical manufacturing infrastructure. Indian API suppliers are crucial in the global supply chain due to cost advantages, scalability, and the capacity to meet high-volume demands. Deva Pharmachem has obtained necessary regulatory certifications, enabling it to supply to the global market, including the US and Europe.

3. Dr. Reddy’s Laboratories (India)

Dr. Reddy’s is a prominent contract manufacturer of baricitinib API, providing high-quality synthesis services. Its facilities are inspected and approved by US FDA, EMA, and other leading regulators. Dr. Reddy’s role enhances supply security and enables Lilly to hedge against supply disruptions in other regions.

4. Samsung BioLogics (South Korea)

Samsung BioLogics, predominantly known for biologics, has recently entered the small molecule API space, including baricitinib. Their state-of-the-art manufacturing facilities, coupled with advanced process controls, make them a strategic supplier, particularly for formulations needing precisely controlled API quality.

Formulation and Finished Dosage Form Suppliers

The formulation and packaging of OLUMIANT involve additional specialized suppliers responsible for converting API into pills, tablets, and blister packs. These entities are essential to ensure product integrity, stability, and compliance with regulatory labels.

1. Patheon (Part of Thermo Fisher Scientific)

Patheon has a global footprint capable of scaling formulation and fill-finish operations for OLUMIANT. Their facilities are certified by regulatory agencies to produce finished dosage forms compliant with cGMP, ensuring consistent drug product quality across markets.

2. SGS Life Sciences

SGS provides analytical testing services vital for quality assurance during formulation, stability testing, and batch release. Their testing ensures that OLUMIANT meets pharmacopeial standards, including assays for potency, purity, and excipients compatibility.

3. Local Packaging Partners

In various regions, Lilly partners with local packaging firms to customize labeling and blister packaging, adhering to regional regulatory requirements. These suppliers often operate under strict quality systems and audits to ensure product traceability and compliance.

Distribution and Supply Chain Logistics

Ensuring OLUMIANT’s availability worldwide depends on sophisticated logistics and distribution partners. Eli Lilly collaborates with global supply chain entities to manage inventory, distribution channels, and international regulatory clearance.

1. UPS Supply Chain Solutions

UPS provides temperature-sensitive logistics, critical for maintaining OLUMIANT’s stability during transit. Their expertise in cold chain management upholds product integrity from manufacturing sites to end-user pharmacies.

2. DHL PharmaSolutions

DHL’s specialized pharmaceutical logistics network supports regional distribution, especially in emerging markets. Their compliance with IATA and GDP standards ensures regulatory adherence during transit.

3. Local Distributors and Wholesalers

Regional distributors and pharmacy chains procure OLUMIANT from central warehouses. These entities facilitate timely delivery and stock replenishment in healthcare facilities, ensuring continuous patient access.

Regulatory and Quality Assurance Suppliers

Compliance with global regulatory standards involves third-party testing and certification bodies. Eli Lilly partners with accredited labs for batch testing, stability studies, and pharmacovigilance data collection.

1. Eurofins Scientific

Eurofins provides comprehensive analytical testing, ensuring raw materials, in-process samples, and final products meet stringent pharmacopeial standards. Their global network supports Lilly’s compliance efforts in multiple jurisdictions.

2. Intertek Group

Intertek supports quality assurance processes, audits, and certifications, facilitating regulatory submissions and approvals for OLUMIANT’s markets worldwide.

Emerging Trends and Strategic Considerations

Eli Lilly’s supply chain for OLUMIANT reflects strategic diversification to mitigate risks associated with geopolitical tensions, procurement delays, or quality issues. Increasing reliance on Indian and South Korean suppliers exemplifies this approach. Furthermore, integration of digital supply chain management and real-time tracking enhances transparency and responsiveness.

Biologics and chemical synthesis suppliers are also anticipated to expand collaboration with Lilly in process innovation, capacity expansion, and sustainability initiatives. Suppliers adopting green manufacturing practices and reducing carbon footprints align with Lilly’s corporate responsibility goals and can impact future sourcing decisions.

Conclusion

The supply chain of OLUMIANT involves a complex network of global suppliers specialized in API manufacturing, formulation, packaging, and logistics. Key players include Liomont (Mexico), Deva Pharmachem and Dr. Reddy’s (India), Samsung BioLogics (South Korea), and logistics firms like UPS and DHL. Maintaining a resilient, compliant, and cost-effective supply chain is essential for Lilly to meet global demand, ensure regulatory adherence, and sustain competitive advantage.

Key Takeaways

• Eli Lilly’s diversified supplier base minimizes risks in OLUMIANT’s production and supply chain.
• API sourcing from established Indian and South Korean manufacturers ensures cost efficiency and regulatory compliance.
• Strategic partnerships with contract manufacturers and logistics providers enable scalability and timely delivery.
• Continuous engagement with quality assurance providers guarantees product safety and adherence to international standards.
• Ongoing supply chain innovation and sustainability initiatives are vital for future resilience and market competitiveness.

FAQs

1. Who are the primary API suppliers for OLUMIANT?
   Major API suppliers include Liomont (Mexico), Deva Pharmachem and Dr. Reddy’s (India), and Samsung BioLogics (South Korea).

2. How does Eli Lilly ensure the quality of OLUMIANT’s raw materials?
   Lilly partners with certified suppliers who follow strict cGMP standards and undergo regular audits and testing by independent laboratories like Eurofins and Intertek.

3. What challenges exist in the supply chain for OLUMIANT?
   Challenges include geopolitical risks, raw material shortages, regulatory hurdles, and logistical disruptions, mitigated through diversification and strategic partnerships.

4. Are there alternative suppliers for OLUMIANT’s API?
   While Lilly sources primarily from established suppliers, the company continuously evaluates new manufacturers to ensure supply continuity and cost competitiveness.

5. What role do logistics providers play in the OLUMIANT supply chain?
   Logistics providers like UPS and DHL manage temperature-controlled transportation, customs clearance, and regional distribution to maintain product integrity and availability.

References

[1] Eli Lilly and Company. OLUMIANT Prescribing Information.
[2] US FDA. Inspections and Approvals for API Manufacturers.
[3] Pharmaceutical Technology. Strategies in API Supply Chain Management.
[4] European Medicines Agency. Regulatory Guidelines for Pharmaceutical Manufacturing.
[5] Industry reports and publicly available corporate disclosures on Eli Lilly’s manufacturing partnerships.