Suppliers and packagers for protopic

protopic

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	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777	NDA	Padagis Israel Pharmaceuticals Ltd	45802-390-00	1 TUBE in 1 CARTON (45802-390-00) / 30 g in 1 TUBE	2014-11-20
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777	NDA	Padagis Israel Pharmaceuticals Ltd	45802-390-01	1 TUBE in 1 CARTON (45802-390-01) / 60 g in 1 TUBE	2014-11-20
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777	NDA	Padagis Israel Pharmaceuticals Ltd	45802-390-02	1 TUBE in 1 CARTON (45802-390-02) / 100 g in 1 TUBE	2014-11-20
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777	NDA	Padagis Israel Pharmaceuticals Ltd	45802-700-00	1 TUBE in 1 CARTON (45802-700-00) / 30 g in 1 TUBE	2014-11-20

Last updated: July 31, 2025

ppliers for the Pharmaceutical Drug: PROTOPIC

Introduction

Protopic, the trade name for tacrolimus ophthalmic ointment (0.03%), is primarily prescribed for the management of atopic keratoconjunctivitis and other severe ocular allergic conditions. As a potent immunosuppressant, tacrolimus plays a critical role in ophthalmology, and securing reliable suppliers is vital for manufacturers, healthcare providers, and stakeholders involved in its distribution. This analysis identifies key suppliers, their manufacturing capabilities, market dynamics, and strategic considerations for sourcing Protopic.

Overview of Protopic and Its Composition

Protopic contains tacrolimus, a macrolide immunosuppressant initially developed for preventing organ transplant rejection. Its ophthalmic formulation necessitates precise manufacturing processes to ensure potency, stability, and safety. The active ingredient, tacrolimus, is sourced from specialized chemical manufacturers, and the finished product undergoes rigorous quality control before reaching markets.

Major Suppliers of Tacrolimus for Protopic Production

1. Astellas Pharma Inc.

Astellas Pharmaceuticals is the original developer of Protopic and holds the patent rights for the ophthalmic formulation.

• Role: As the patent holder and manufacturer of the finished product, Astellas supplies Protopic directly to markets globally, including the US, Europe, and Japan.
• Supply Chain Position: Vertically integrated; controls both active pharmaceutical ingredient (API) sourcing and finished product distribution, ensuring consistency and quality assurance.

2. Fujifilm Toyama Chemical Co., Ltd.

A significant supplier of tacrolimus raw materials, especially for Japan and Asia-Pacific markets.

• Capabilities: Produces pharmaceutical-grade tacrolimus with high purity standards.
• Status: Supplies tacrolimus to Astellas and third-party manufacturers under licensing agreements.

3. Biocon Ltd. and Strides Pharma Science Ltd.

Indian pharmaceutical companies that have expanded into the biosimilar and generic immunosuppressants market.

• Role: Some have developed generic formulations of tacrolimus for oral and topical use.
• Relevance: While not currently the primary suppliers for Protopic in ophthalmic form, they represent potential competitors or alternate sources for tacrolimus bulk material.

4. Emerging API Manufacturers in China and India

Recent developments note increasing production capacity from Chinese and Indian API manufacturers such as Jiangsu Hengrui Medicine Co. Ltd. and Cipla Ltd.

• Quality Standards: These manufacturers are subject to stringent regulatory inspections, including USFDA and EMA approvals, to meet global pharmaceutical standards.
• Implication: They could serve as alternative sources for tacrolimus supply, especially amidst global supply chain challenges.

Finished Product Manufacturing and Packaging

Astellas Pharma’s Manufacturing Facilities

Astellas operates specialized plants equipped to produce ophthalmic ointments under Good Manufacturing Practice (GMP) standards.

• Locations: Primarily in Japan, with manufacturing partnerships in Europe and North America.
• Control: Ensures patent protection and consistent formulation quality.

Generic and Biosimilar Markets

With patent expiration and regulatory approval of generic tacrolimus formulations, other players have entered the market, potentially producing ophthalmic ointments similar to Protopic.

• Notable Generic Manufacturers: Sandoz, Teva Pharmaceuticals, and Mylan.
• Regulatory Challenges: These companies must navigate complex patent landscapes and demonstrate bioequivalence for ophthalmic formulations.

Market Dynamics and Supply Chain Considerations

Supply Security

The tight control by Astellas and reliance on limited API manufacturing sources create potential bottlenecks. As demand for tacrolimus increases for various indications, including off-label uses, supply chain disruptions could affect availability.

Regulatory Compliance

Procurement from suppliers adhering to GMP standards and obtaining necessary certifications (USFDA, EMA, PMDA) ensures regulatory compliance for finished products.

Pricing Trends

The cost of tacrolimus API influences the price of Protopic formulations. Generic entrants and multiple API suppliers exert downward pressure on pricing, expanding accessibility but necessitating quality assurances.

Emerging Trends and Strategic Sourcing Opportunities

• Diversification of API Suppliers: To mitigate risk, manufacturers seek multiple source agreements with certified API producers, especially in regions with growing pharmaceutical manufacturing capabilities.
• Partnerships and Licensing Agreements: Strategic collaborations between innovator companies like Astellas and manufacturing partners facilitate stable supply chains and geographic expansion.
• Technological Innovation: Advanced synthesis methods and quality control enhance the stability and bioavailability of tacrolimus, supporting reliable supply for ophthalmic applications.

Regulatory and Quality Assurance Aspects

• Global Certification: Suppliers must comply with regulatory standards, including those governed by the USFDA, EMA, and Japan’s PMDA.
• Batch Consistency: The manufacturing process must ensure high purity and consistent potency, given tacrolimus’s immunosuppressive potency and safety profile.
• Traceability: Supply chain transparency is crucial to monitor material origins, batch history, and compliance documentation.

Conclusion

The primary supplier for Protopic remains Astellas Pharma, which controls the manufacture and distribution of the branded ophthalmic ointment. However, the tacrolimus API is sourced from specialized manufacturers such as Fujifilm Toyama Chemical and emerging players in China and India, who possess capacities to meet global demand. Strategic partnerships, diversified sourcing, and rigorous quality assurance protocols are critical to maintaining a reliable supply chain for Protopic, especially amid increasing global demand and supply constraints.

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Key Takeaways

• Astellas remains the dominant supplier, controlling the finished product of Protopic and securing API through strategic partnerships.
• API sourcing from reputable manufacturers like Fujifilm Toyama ensures quality and compliance for ophthalmic formulations.
• Emerging markets in China and India present potential alternative API sources, highlighting the importance of supply chain diversification.
• Regulatory compliance and quality assurance are vital in maintaining the integrity of the supply chain, particularly for immunosuppressants like tacrolimus.
• Future opportunities include leveraging technological innovation and strategic alliances to secure a resilient supply chain amid growing global demand.

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FAQs

Q1: Who is the primary manufacturer of Protopic?
A: Astellas Pharma Inc. is the primary manufacturer and patent holder of Protopic, overseeing its formulation, production, and distribution.

Q2: Can tacrolimus APIs be sourced from generic manufacturers?
A: Yes, several generic manufacturers in India and China produce tacrolimus API, but regulatory approvals and quality controls are essential for ensuring safety and efficacy.

Q3: Are alternatives to Astellas' tacrolimus available for manufacturing Protopic?
A: Potentially, but only if APIs meet strict regulatory standards. Currently, Astellas remains the main source for the finished ophthalmic ointment.

Q4: What are the key considerations when sourcing tacrolimus for ophthalmic use?
A: Ensuring high purity, stability, GMP compliance, and regulatory approvals are critical, along with supply chain reliability and traceability.

Q5: How might patent expirations influence supplier options for Protopic?
A: Patent expirations enable generic manufacturing, increasing competition and potentially expanding supplier options but require rigorous bioequivalence testing and regulatory clearance.

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References

1. Astellas Pharma Inc. — Official website, product information.
2. Fujifilm Toyama Chemical Co., Ltd. — API manufacturing capabilities, industry reports.
3. World Health Organization. (2022). Global API production data.
4. U.S. Food and Drug Administration. (2021). GMP standards for API manufacturing.
5. Market intelligence reports on immunosuppressant drug supply chains.