XULANE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Technologies	XULANE	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	200910	ANDA	Mylan Pharmaceuticals Inc.	0378-3340-32	1 POUCH in 1 CARTON (0378-3340-32) / 1 PATCH in 1 POUCH (0378-3340-17) / 7 d in 1 PATCH	2014-04-16
Mylan Technologies	XULANE	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	200910	ANDA	Mylan Pharmaceuticals Inc.	0378-3340-53	3 POUCH in 1 CARTON (0378-3340-53) / 1 PATCH in 1 POUCH (0378-3340-16) / 7 d in 1 PATCH	2014-04-16
Mylan Technologies	XULANE	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	200910	ANDA	A-S Medication Solutions	50090-1683-0	3 POUCH in 1 CARTON (50090-1683-0) / 1 d in 1 POUCH	2014-04-16
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Xulane (ethinyl estradiol and norelgestromin) is a transdermal contraceptive patch approved by the U.S. Food and Drug Administration (FDA) for birth control. Since its introduction in 2016, Xulane has become a significant player in hormonal contraception, leveraging innovative transdermal delivery to improve compliance and efficacy. Its manufacturing involves a complex supply chain of raw materials, patch components, and specialized pharmaceuticals. This article provides a comprehensive analysis of suppliers contributing to the production of Xulane, focusing on key raw materials, manufacturing components, and technological partners integral to its supply chain.

Raw Material Suppliers

1. Ethinyl Estradiol (EE)

Ethinyl estradiol, a synthetic estrogen, is a critical component of Xulane. Multiple multinational pharmaceutical ingredient manufacturers produce EE, with key suppliers including:

BASF (Germany): A leading supplier of active pharmaceutical ingredients (APIs), BASF supplies high-purity EE used in hormonal contraceptives, including Xulane. Their rigorous quality control and global distribution network make them a primary choice for pharmaceutical manufacturers [1].
Mitsubishi Chemical (Japan): Known for its robust API production capacity, Mitsubishi Chemical supplies pharmaceutical-grade EE conforming to global standards.
Leon Pharmaceutical (South Korea): Specializes in hormone APIs, including EE, and provides tailored solutions for transdermal systems.

2. Norelgestromin

Norelgestromin, the progestin component, is synthesized through complex chemical processes:

Dr. Reddy’s Laboratories (India): A key manufacturer of norelgestromin, supplying pharmaceutical companies with high-grade progestins suitable for transdermal patches.
Sachem Inc. (USA): Supplies pharmaceutical-grade norelgestromin for various formulations, including contraceptive patches.
AbbVie (USA): Historically involved in hormone API production, supplying norelgestromin in finished pharmaceuticals.

3. Excipients and Adhesives

3M (USA): Supplies medical-grade adhesives and backing layers essential for transdermal patch manufacturing, ensuring optimal adhesion, skin compatibility, and controlled drug delivery.
BASF (Germany): Provides polymers and excipient ingredients for layer formation and controlled release.
Dow Chemical (USA): Offers medical adhesives and polymers with proven biocompatibility for patch substrates.

Component Manufacturers for the Transdermal Patch

1. Patch Backing and Outer Layer Materials

Stanley Black & Decker (USA): Manufactures specialty films and backing layers that provide durability, flexibility, and protection for the patch.
Avon Rubber (UK): Supplies medical-grade film substrates optimized for transdermal applications.

2. Release Liners

UCB (Belgium): Produces silicone-coated release liners critical for manufacturing efficiency and product stability.
Berry Global (USA): Supplies silicone and non-silicone coated liners that facilitate clean removal during application.

3. Adhesive Layers

3M (USA): As previously mentioned, supplies advanced adhesives that maintain skin adherence while preventing irritation.
Lohmann (Germany): Develops specialized medical adhesives for transdermal delivery systems.

Technological and Contract Manufacturing Partners

Walgreens Boots Alliance (USA): Historically involved in distribution channels, ensuring wide market reach.
Teva Pharmaceutical Industries (Israel): A contract manufacturer capable of producing transdermal patches at scale under licensing agreements, ensuring supply chain robustness.
Innovative Contract Manufacturers (CMOs): Several CMOs in countries like India, China, and the USA hold capacity for GMP-compliant manufacturing of the patch components, including adhesives, backing materials, and active API formulation.

Regulatory and Quality Assurance Suppliers

Certara (USA): Provides modeling and simulation software to optimize drug delivery and release kinetics, aiding manufacturers in quality assurance.
Eurofins Scientific (Luxembourg): Offers comprehensive testing services ensuring APIs and finished patches meet regulatory standards globally.

Supply Chain Challenges and Considerations

The supply chain for Xulane demands high levels of quality, regulatory compliance, and geographic diversification to mitigate risks such as geopolitical tensions, raw material shortages, and regulatory delays. For example, reliance on a limited number of API suppliers amplifies supply chain vulnerabilities, as seen during the COVID-19 pandemic.

Market Dynamics and Supplier Trends

Vertical Integration: Major pharmaceutical firms like Janssen (a Johnson & Johnson subsidiary, manufacturer of Xulane) often pursue vertical integration, securing key raw materials and production capacities to ensure supply consistency.
Material Innovation: The focus on developing new adhesive technologies and backing materials aims to improve patient comfort and adherence, influencing supplier innovation pathways.
Geopolitical Factors: Suppliers in Asia (India, South Korea, China) play a growing role, with efforts to maintain quality standards aligning with FDA and EMA regulations.

Conclusion

The supply chain for Xulane involves a complex network of global suppliers delivering high-quality active ingredients, adhesive technologies, and patch components. Leading suppliers such as BASF, Dr. Reddy’s, 3M, and UCB underpin the manufacturing process, emphasizing the importance of diversified sourcing and stringent quality controls. As demand for transdermal contraceptive options expands, supply chain resilience and technological innovation among these suppliers will shape future availability and competitiveness.

Key Takeaways

The core raw materials for Xulane include ethynyl estradiol and norelgestromin, supplied predominantly by BASF, Mitsubishi Chemical, Dr. Reddy’s, and Sachem Inc.
Critical components for the patch, including adhesives, backing films, and release liners, are sourced from industry leaders like 3M, Dow Chemical, and Berry Global.
Manufacturers and CMOs globally play vital roles in large-scale, compliant production, with key players in the USA, India, and Europe.
Ensuring supplier diversification and adherence to regulatory standards is crucial for maintaining supply chain robustness.
Innovation in patch technology and materials remains a strategic focus for suppliers aiming to enhance patient compliance and product performance.

Frequently Asked Questions (FAQs)

1. Who are the main active pharmaceutical ingredient (API) suppliers for Xulane?
BASF (Germany), Mitsubishi Chemical (Japan), Dr. Reddy’s Laboratories (India), and Sachem Inc. (USA) are primary suppliers providing ethynyl estradiol and norelgestromin.

2. Which companies provide components like adhesives and backing films for the Xulane patch?
3M (USA), UCB (Belgium), Lohmann (Germany), and Berry Global (USA) supply adhesives, backing layers, and release liners critical for manufacturing.

3. Are there regional differences in suppliers for Xulane components?
Yes. While some suppliers like BASF and 3M operate globally, many components are sourced from Asia (India, China, Korea) due to cost and capacity advantages.

4. How does supply chain diversification impact Xulane’s manufacturing stability?
Diversification reduces dependency on single suppliers, mitigating risks from geopolitical, regulatory, or pandemic-related disruptions, thereby ensuring consistent product supply.

5. What role do contract manufacturing organizations (CMOs) play in Xulane production?
CMOs provide large-scale GMP-compliant manufacturing, offering flexibility and capacity expansion, essential for meeting global demand without overextending proprietary facilities.

References

[1] BASF. "Active ingredients for pharmaceutical applications." BASF Product Portfolio, 2022.

Suppliers and packagers for XULANE

XULANE

Suppliers for the Pharmaceutical Drug: Xulane