Suppliers and packagers for generic pharmaceutical drug: TOFACITINIB CITRATE

TOFACITINIB CITRATE

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	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082	NDA	Pfizer Laboratories Div Pfizer Inc	0069-1029-02	1 BOTTLE in 1 CARTON (0069-1029-02) / 240 mL in 1 BOTTLE (0069-1029-01)	2021-02-08
Pfizer	XELJANZ	tofacitinib citrate	SOLUTION;ORAL	213082	NDA	U.S. Pharmaceuticals	63539-029-02	1 BOTTLE in 1 CARTON (63539-029-02) / 240 mL in 1 BOTTLE (63539-029-01)	2021-02-08
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0501-30	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0501-30)	2016-03-07
Pfizer	XELJANZ XR	tofacitinib citrate	TABLET, EXTENDED RELEASE;ORAL	208246	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0502-30	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0502-30)	2020-01-21

Suppliers for the Pharmaceutical Drug: Tofacitinib Citrate

Last updated: July 27, 2025

Introduction

Tofacitinib citrate, marketed primarily under the brand name Xeljanz, is an oral Janus kinase (JAK) inhibitor approved for treating rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Since its approval by the FDA in 2012, the global supply chain landscape for tofacitinib citrate has evolved significantly, driven by patent protections, manufacturing capacities, and strategic collaborations among pharmaceutical companies. This analysis provides a comprehensive overview of the primary suppliers of tofacitinib citrate, including manufacturing origins, licensing arrangements, and market distribution, offering insights for stakeholders across the pharmaceutical industry.

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Global Manufacturing and Leading Suppliers

1. Pfizer Inc. — Original Developer and Primary Supplier

Pfizer Inc. secured FDA approval for tofacitinib citrate in 2012, making it the original manufacturer and a dominant supplier worldwide. Pfizer’s global manufacturing infrastructure supports the production of tofacitinib citrate in multiple facilities, ensuring a stable supply chain. The company's extensive investments in quality control, regulatory compliance, and capacity expansion have positioned it as a primary source for genuine tofacitinib citrate.

2. Contract Manufacturing Organizations (CMOs)

Pfizer utilizes third-party CMOs to augment manufacturing capacity and ensure supply continuity. These CMOs often operate under strict licensing and quality agreements. Notable CMO partners include:

• Accord Healthcare: Provides manufacturing services for Pfizer and other pharmaceutical companies, especially in the generics segment.

• Siegfried Holding AG: Known for handling complex drug formulations and active pharmaceutical ingredient (API) manufacturing, including tofacitinib citrate.

The reliance on CMOs allows Pfizer to diversify manufacturing risks and maintain supply levels amid rising demand and regulatory challenges.

3. Generics Manufacturers and Non-Patent Markets

Following Pfizer’s patent expiration in key territories such as India and the European Union, several generic pharmaceutical companies have entered the market, producing biosimilar versions of tofacitinib citrate. These manufacturers primarily source APIs from regional suppliers and may develop their own formulations.

• Zydus Cadila: An Indian firm authorized to produce generic tofacitinib citrate after patent expiry, sourcing APIs domestically and globally.

• Sun Pharmaceutical Industries: Also engages in manufacturing domestic versions, often utilizing regional API suppliers or collaborating with international API producers.

• Mylan (now part of Viatris): Entered the market with generic tofacitinib citrate, leveraging local API providers to meet regional demand.

4. API Suppliers

API production is critical, especially for generics, where sourcing quality APIs from reliable suppliers is essential. Major API suppliers for tofacitinib citrate include:

• Hetero Labs (India): Supplies APIs to multiple generic manufacturers, with robust manufacturing practices compliant with international standards.

• Cipla (India): Known for API manufacturing, Cipla produces tofacitinib citrate APIs for regional distribution and export.

• Dr. Reddy’s Laboratories: Offers APIs for the global market, maintaining strict adherence to Good Manufacturing Practices (GMP).

Additionally, some companies export APIs from Chinese manufacturers, which are often used by generic firms in Asia and Africa.

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Licensing, Partnerships, and Regulatory Dynamics

1. Pfizer’s Licensing Strategies

In licensing agreements, Pfizer collaborates with regional pharmaceutical companies to manufacture and distribute tofacitinib citrate in different markets. These agreements often include technology transfers and quality assurances to meet local regulatory standards.

2. Patent Expiry and Market Entry of Generics

The expiration of Pfizer's patents has significantly diversified the supplier landscape. Countries like India (patented until 2023, extended in some cases) and the EU have seen numerous generic manufacturers enter the market. This proliferation has led to price erosion and increased accessibility, but also introduces supply chain complexity.

3. Regulatory Approvals and Supply Chain Compliance

Manufacturers must obtain regulatory approvals from agencies like the FDA, EMA, and local authorities. Ensuring supply chain compliance, including API sourcing and manufacturing practices, impacts supplier choices and market stability.

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Market Dynamics and Supply Chain Challenges

1. Supply Security and Quality Assurance

Ensuring a consistent, high-quality supply of tofacitinib citrate is crucial, especially given the drug’s chronic use in autoimmune conditions. Pfizer's tight control over manufacturing and quality standards minimizes risks of supply disruptions.

2. Geopolitical and Regulatory Risks

Trade restrictions, geopolitical tensions, and regulatory changes can impact the supply chain. For example, recent export restrictions from Chinese API manufacturers pose risks to global availability.

3. Cost Pressures and Market Competition

The entry of multiple generic suppliers has driven down prices, compelling manufacturers to optimize production costs, often sourcing APIs from emerging manufacturing regions. However, quality assurance remains paramount, especially for biosimilar versions.

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Regional Supplier Trends

• North America & Europe: Pfizer remains the primary supplier, with limited generic activity due to patent protections and regulatory hurdles.

• India & Asia: Major API and generic manufacturing hubs, with companies like Hetero, Cadila, and Cipla leading the supply of biosimilar and generic tofacitinib citrate.

• Emerging Markets: Depend heavily on Indian and Chinese APIs, with increasing local manufacturing licenses in Latin America, Africa, and Southeast Asia.

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Future Outlook

The global supply chain for tofacitinib citrate is expected to evolve with the potential advent of biosimilar versions, market expansion into new territories, and ongoing capacity investments. Innovations in API manufacturing, supply chain transparency, and regulatory harmonization will continue to shape supplier strategies.

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Key Takeaways

• Pfizer remains the primary original supplier, leveraging extensive manufacturing infrastructure and quality controls.

• Generic manufacturers and CMOs have expanded the supply landscape, especially post-patent expiration, with significant contributions from Indian API producers.

• API sourcing remains crucial, with Indian and Chinese manufacturers dominating global supplies; supply security is challenged by geopolitical and regulatory factors.

• Licensing and strategic partnerships enable regional distribution and market penetration for biosimilars and generics.

• Supply chain resilience hinges on balancing cost efficiency, quality assurance, and compliance amid evolving regulatory and geopolitical landscapes.

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FAQs

1. Who are the main manufacturers of tofacitinib citrate globally?
Pfizer Inc. is the original and primary manufacturer, with additional supply supplied by CMOs such as Siegfried and Accord Healthcare. Post-patent expiry, numerous Indian generic firms like Zydus Cadila and Sun Pharma produce biosimilars and generics, sourcing APIs from regional suppliers.

2. Are there generic versions of tofacitinib citrate available?
Yes. Several Indian pharmaceutical companies manufacture generic tofacitinib citrate, especially in markets where Pfizer’s patents have expired. These generics often source APIs from regional suppliers and adhere to local regulatory standards.

3. What are the primary API sources for tofacitinib citrate?
Major API producers include Indian companies like Hetero Labs, Cipla, and Dr. Reddy’s Laboratories, with Chinese API manufacturers also contributing to the global market.

4. How are supply chain risks managed for tofacitinib citrate?
Manufacturers mitigate risks by diversifying API sources, establishing licensing agreements with regional partners, and maintaining strategic inventory reserves. Regulatory compliance and consistent quality assurance are central to supply security.

5. What is the future outlook for the supply of tofacitinib citrate?
The market is expected to see increased generic competition and biosimilar development. Supply chain resilience will depend on regulatory harmonization, API source diversification, and capacity investments by manufacturers.

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References

[1] U.S. Food and Drug Administration. (2012). FDA approves Xeljanz for rheumatoid arthritis.
[2] Pfizer Inc. Annual Reports and Public Securities Filings.
[3] Global data on API manufacturing from IQVIA Institute reports.
[4] Indian Patent Office and DCGI approvals for biosimilars and generics.
[5] Industry analyses from EvaluatePharma and Pharma Intelligence.