Suppliers and packagers for generic pharmaceutical drug: PIMECROLIMUS

PIMECROLIMUS

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302	NDA	Bausch Health US, LLC	0187-5100-01	1 TUBE in 1 CARTON (0187-5100-01) / 30 g in 1 TUBE	2001-12-02
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302	NDA	Bausch Health US, LLC	0187-5101-02	1 TUBE in 1 CARTON (0187-5101-02) / 60 g in 1 TUBE	2001-12-02
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302	NDA	Bausch Health US, LLC	0187-5102-03	1 TUBE in 1 CARTON (0187-5102-03) / 100 g in 1 TUBE	2001-12-02
Bausch	ELIDEL	pimecrolimus	CREAM;TOPICAL	021302	NDA	Bausch Health US, LLC	0187-5103-04	1 TUBE in 1 CARTON (0187-5103-04) / 5 g in 1 TUBE	2001-12-02

Last updated: July 27, 2025

ppliers for the Pharmaceutical Drug: Pimecrolimus

Introduction
Pimecrolimus, a topical calcineurin inhibitor, is predominantly prescribed for treating inflammatory skin conditions such as atopic dermatitis. As a critical immunomodulatory agent, its supply chain is integral to pharmaceutical manufacturing, healthcare delivery, and global market stability. Identifying key suppliers and understanding their roles in the pimecrolimus supply ecosystem is essential for stakeholders seeking procurement strategies, ensuring regulatory compliance, and safeguarding supply continuity.

Overview of Pimecrolimus & Industry Dynamics
Pimecrolimus was developed by Novartis and is marketed under brand names such as Elidel®. It functions by selectively inhibiting T-lymphocyte activation, reducing inflammatory cytokine release. Given its specific pharmacological profile and formulation requirements, the manufacturing process and raw material sourcing are tightly controlled, limiting the number of suppliers involved in its production chain.

The global pimecrolimus market remains relatively concentrated, with few dominant suppliers primarily associated with licensed manufacturing and proprietary formulations. The drug’s complex synthesis involves precursor compounds and advanced chemical processes, necessitating high-quality raw materials supplied by specialized chemical companies.

Key Raw Material Suppliers
The synthesis of pimecrolimus relies on several critical intermediates and raw chemicals, including complex macrocyclic precursors derived from fermentation or chemical synthesis routes. Major suppliers of these high-grade chemical components include:

• Sigma-Aldrich (Merck Group): Provides raw chemicals and specialty reagents used in the synthesis process, including precursors and solvents. Their extensive catalog supports pharmaceutical synthesis and R&D activities.
• Thermo Fisher Scientific: Offers high-purity raw chemicals, solvents, and intermediates to support pharmaceutical manufacturing.
• Alfa Aesar (Part of Thermo Fisher Scientific): Supplies specialized chemicals, including complex intermediates necessary for macrocyclic compound synthesis.

While these companies do not produce pimecrolimus directly, their substrates and reagents are essential for manufacturing the active pharmaceutical ingredient (API).

Active Pharmaceutical Ingredient (API) Manufacturing
The primary production of pimecrolimus API is controlled by a limited pool of licensed producers primarily affiliated with Novartis or its licensing partners. Due to intellectual property protections, market exclusivity, and quality standards, only a handful of manufacturers have the license or capacity to produce pharmaceutical-grade API.

• Novartis AG: As the originator and patent holder, Novartis is the principal supplier of pimecrolimus API. The company maintains internal manufacturing facilities with strict quality controls, and often outsources some manufacturing stages to specialized CDMOs (Contract Development and Manufacturing Organizations).
• Contract Manufacturing Organizations (CMOs): Several CMOs with licensed capacity produce pimecrolimus API under strict confidentiality agreements. These include companies like Mundipharma BioPharma (India), which has been reported involved in the production of immunosuppressive APIs, and Lonza—a prominent player in contract manufacturing, although specific involvement in pimecrolimus production remains unconfirmed publicly.

Since demand is niche, the number of licensed API suppliers is relatively limited, creating dependency on a small, highly controlled pool.

Formulation and Final Product Suppliers
After API procurement, formulation and packaging are performed by pharmaceutical companies licensed to produce topical formulations of pimecrolimus. Major drug manufacturers, apart from Novartis, may produce generic versions following patent expiry or under licensing agreements.

• Teva Pharmaceutical Industries: Has pursued generic licensing for pimecrolimus formulations in various markets, leveraging existing APIs and formulation expertise.
• Sandoz (Novartis division): Engages in producing generic formulations, maintaining supply for markets with generic uptake.

Regional manufacturers also operate in markets like Asia, often sourcing API from licensed or alternative suppliers under strict quality agreements.

Regulatory & Quality Considerations
The procurement and supply of pimecrolimus are heavily regulated, with compliance to cGMP (current Good Manufacturing Practice) standards being mandatory. Suppliers must possess certifications from regulatory agencies such as the FDA, EMA, or local health authorities. Supply chain security, traceability, and purity standards are critical in ensuring patient safety and market approval.

Emerging Sources & Biosimilar Developments
While biosimilars are more common for biologics, ongoing research into alternative derivatives of pimecrolimus may open new manufacturing pathways, potentially involving different raw material suppliers or biotechnological producers. As patent protections lapse, new entrants could emerge with different supply chains, diversifying the sourcing landscape.

Supply Chain Challenges & Market Risks

• Limited supplier base: The specialized nature of pimecrolimus manufacturing limits the number of active suppliers, increasing vulnerability to production disruptions.
• Regulatory constraints: Licensing agreements restrict API production to sanctioned manufacturers, limiting entrance by new suppliers without regulatory approval.
• Raw material shortages: Fluctuations in the availability of key intermediates can impact API manufacturing and delivery schedules.
• Geopolitical factors: Trade policies, export restrictions, and geopolitical tensions influence supply chain stability, especially in regions heavily reliant on specific suppliers.

Conclusion
The supply chain for pimecrolimus is characterized by a small, tightly controlled ecosystem of licensed API producers, reputable raw material suppliers, and formulators. Primary responsibility lies with Novartis, leveraging both internal manufacturing and external CMOs, alongside a handful of regional generic manufacturers and chemical suppliers. Ensuring supply security necessitates vigilant management of licensing, raw material sourcing, and regulatory compliance, especially as markets evolve and patent protections expire.

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Key Takeaways

• Pimecrolimus’s supply chain hinges on a limited number of licensed API manufacturers, primarily Novartis and select CMOs.
• Raw material suppliers such as Sigma-Aldrich and Thermo Fisher provide essential chemicals and intermediates but do not produce the API itself.
• Regulatory compliance, quality standards, and licensing restrict market entry, making supply chain diversification challenging.
• Regional manufacturers and generic companies rely on licensed API sources, with potential for increased competition post-patent expiry.
• Supply risks include raw material shortages, geopolitical issues, and dependency on a small manufacturer pool, underscoring the need for strategic procurement planning.

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FAQs

1. Who are the main suppliers of pimecrolimus API?
The primary supplier is Novartis, with contracted CMOs producing the API under licensing agreements. Other licensed manufacturers may include regional firms, depending on market and regulatory arrangements.

2. Are there alternative sources of raw materials for pimecrolimus synthesis?
While raw material suppliers like Sigma-Aldrich and Thermo Fisher provide chemicals used in synthesis, alternative sources are limited due to the high specificity and regulatory requirements of the compounds involved.

3. Can new suppliers enter the pimecrolimus supply chain easily?
Entry is challenging due to patent protections, strict regulatory standards, quality requirements, and licensing restrictions, which limit the number of qualified manufacturers.

4. What are common risks associated with pimecrolimus supply?
Risks include production delays due to raw material shortages, regulatory hurdles, geopolitical tensions, and reliance on a small number of licensed API producers.

5. How does patent expiration affect the supply chain?
Patent expiry opens opportunities for generic manufacturing, increasing the number of API suppliers and formulators, potentially reducing costs and improving supply resilience.

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Sources
[1] Novartis AG, Pimecrolimus Product Information, 2022.
[2] Sigma-Aldrich Chemical Catalog, 2023.
[3] Pharmaceutical Market Reports, 2022.
[4] EMA & FDA Regulatory Guidelines on API Manufacturing, 2022.