Suppliers and packagers for enstilar

enstilar

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	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589	NDA	LEO Pharma Inc.	50222-302-60	1 CAN in 1 CARTON (50222-302-60) / 60 g in 1 CAN	2015-10-16
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589	NDA	LEO Pharma Inc.	50222-302-66	2 CAN in 1 CARTON (50222-302-66) / 60 g in 1 CAN	2015-10-16
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589	NDA	LEO Pharma Inc.	50222-302-91	1 CAN in 1 CARTON (50222-302-91) / 60 g in 1 CAN	2015-10-16

Suppliers for the Pharmaceutical Drug: Enstilar

Last updated: July 27, 2025

Introduction

Enstilar is a topical medication branded by LEO Pharma, primarily used for treating psoriasis vulgaris and scalp psoriasis. Its formulation contains calcipotriol as the active vitamin D analog and betamethasone dipropionate as a potent corticosteroid. Given its pharmacological composition, Enstilar's supply chain involves various specialized pharmaceutical manufacturers, raw material suppliers, and third-party contract manufacturing organizations (CMOs). Ensuring an understanding of these suppliers is critical for stakeholders in procurement, regulatory compliance, and market strategy.

Active Pharmaceutical Ingredient (API) Suppliers

The core of Enstilar’s formulation involves two APIs: calcipotriol and betamethasone dipropionate. The sourcing of these APIs is pivotal for maintaining product quality, consistency, and regulatory adherence.

1. Calcipotriol Suppliers

Calcipotriol, a synthetic vitamin D analog, is manufactured by several global API producers. Major suppliers include:

• Chugai Pharmaceutical (Japan): Known for high-quality vitamin D analogs, Chugai supplies calcipotriol to multiple pharmaceutical firms, often through licensing agreements or direct supply contracts.

• STADA Arzneimittel (Germany): A prominent European API contributor, STADA offers calcipotriol for topical formulations, with strict GMP-compliant manufacturing standards.

• Shandong Sifang Pharmaceutical (China): An emerging supplier providing calcipotriol APIs at a competitive price point, though quality verification is requisite for market approval.

2. Betamethasone Dipropionate Suppliers

As a potent corticosteroid, betamethasone dipropionate's suppliers include:

• BASF (Germany): A key global manufacturer, BASF supplies pharmaceutical-grade betamethasone derivatives with consistent purity and regulatory certifications.

• Sigma-Aldrich (Merck Group): Offers betamethasone dipropionate for research and commercial use; supply for pharmaceutical production requires additional validation.

• Mingxin Pharmaceutical (China): Supplies betamethasone dipropionate to emerging markets, often at cost advantages, but with varying standards of compliance.

Excipients and Formulation Components

Aside from APIs, the formulation of Enstilar involves excipients and aerosols, supplied by:

• BASF and Dow Chemical: For propellants, propellants such as HFA propellants are standard.

• Global excipient manufacturers: Including Ashland and Evonik for stabilizers, emulsifiers, and other formulation ingredients.

Contract Manufacturing Organizations (CMOs)

Given the complex formulation, LEO Pharma likely partners with specialized CMOs for manufacturing and packaging. These CMOs typically possess:

• GMP Certified Facilities: Ensuring compliance with regulatory standards (FDA, EMA, PMDA).

• Expertise in Topical and Aerosol Formulations: To ensure product stability and efficacy.

Note: Specific CMO identities are often confidential; however, major players in topical pharmaceutical manufacturing such as Almirall, Catalent, and Lonza might be involved in similar products' manufacturing.

Distribution and Logistics Partners

Once produced, Enstilar’s distribution involves pharmaceutical logistics providers who manage cold chain, inventory, and regional compliance. Major logistics companies include:

• DHL Supply Chain

• UPS Healthcare

• FedEx Healthcare

These partners facilitate global distribution, ensuring timely delivery to wholesalers and pharmacies, critical in maintaining product shelf life and regulatory adherence.

Regulatory and Quality Assurance

Suppliers of APIs and excipients must comply with international GMP standards. The approvals are validated via regulatory dossiers, including DEA licenses for controlled substances (betamethasone derivative) and EMA/FDA approvals for APIs.

Impacts of Supplier Selection

• Quality Assurance: Ensuring supplier compliance with GMP influences product safety, efficacy, and regulatory approval.

• Cost Management: Competitive sourcing reduces production costs while maintaining quality.

• Supply Chain Resilience: Diversification among suppliers mitigates risks related to geopolitical issues, pandemics, or regulatory delays.

• Regulatory Risks: Changes in supplier manufacturing practices or regulatory status can impact market authorization or supply continuity.

Conclusion

Securing a reliable supply chain for Enstilar involves meticulous selection of API and excipient suppliers, contracting with experienced CMOs, and establishing robust logistics partnerships. Given the critical importance of product quality and regulatory compliance in pharmaceutical manufacturing, diversified sourcing paired with stringent quality controls remains essential for continuous supply.

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Key Takeaways

• Enstilar's critical components, calcipotriol and betamethasone dipropionate, are sourced from global API manufacturers with stringent GMP compliance.

• Major API suppliers include BASF, Chugai Pharmaceutical, STADA, and Mingxin Pharmaceutical.

• Contract manufacturing is often outsourced to specialized CMOs with expertise in topical formulations; confidentiality limits disclosed identities.

• Ensuring supplier quality, regulatory compliance, and diversified sourcing is vital to mitigate supply chain disruptions.

• Logistics partners such as DHL, UPS, and FedEx facilitate global distribution, maintaining product integrity.

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FAQs

1. Who are the primary suppliers of calcipotriol for Enstilar?
Leading suppliers include Chugai Pharmaceutical (Japan), STADA Arzneimittel (Germany), and Shandong Sifang Pharmaceutical (China), each complying with global GMP standards.

2. What regulatory challenges might affect Enstilar's raw material supply?
Regulatory issues such as GMP compliance violations, changes in API manufacturing licenses, or geopolitical restrictions can disrupt supply chains.

3. How does supplier diversification benefit Enstilar’s manufacturing process?
Diversification reduces dependency on a single source, enhances supply stability, mitigates risks of shortages, and helps negotiate better pricing.

4. Are there any regional differences in suppliers for Enstilar's APIs?
Yes. European and Japanese suppliers generally adhere to higher regulatory standards, while Chinese suppliers offer cost advantages with varying levels of compliance that require verification.

5. What role do CMOs play in Enstilar's production?
CMOs handle formulation, manufacturing, and packaging, ensuring adherence to quality standards essential for regulatory approval and market consistency.

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Sources

[1] European Medicines Agency. "Calcipotriol." EMA Public Assessment Reports.
[2] BASF. "Betamethasone Derivatives Product Portfolio." BASF Technical Data Sheets.
[3] Global Pharma Supply Chain Reports, 2022.
[4] LEO Pharma. "Enstilar Product Monograph."
[5] Regulatory Affairs Publications. "GMP Standards and Pharmaceutical API Sourcing."