XULANE bulk active fine chemical suppliers

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Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical	⤷ Get Started Free	2023-05-5H00410	⤷ Get Started Free
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Last updated: November 20, 2025

Introduction

XULANE, a transdermal contraceptive patch marketed by Janssen Pharmaceuticals, delivers a combination of ethinyl estradiol and norelgestromin—the active pharmaceutical ingredients (APIs) responsible for its contraceptive efficacy. Securing reliable, high-quality bulk sources of these APIs is crucial for manufacturing the XULANE patch, ensuring consistent drug performance, regulatory compliance, and cost management. This report assesses the global landscape of API suppliers for ethinyl estradiol and norelgestromin, emphasizing quality standards, market dynamics, and sourcing considerations pivotal to pharmaceutical manufacturers and stakeholders.

Overview of the APIs in XULANE

Ethinyl Estradiol (EE): A synthetic estrogen used broadly in contraceptive and hormone replacement therapy formulations, EE integrates into the transdermal patch to inhibit ovulation effectively.

Norelgestromin (NGMN): A potent progestin derived from norgestimate, norelgestromin acts synergistically with EE to suppress ovulation and alter cervical mucus, contributing to the contraceptive effect.

Ensuring a continuous and reliable supply of these APIs at pharmaceutical-grade quality is fundamental for XULANE production, with suppliers adhering to Good Manufacturing Practices (GMP), regulatory standards, and quality control norms.

Major API Suppliers for Ethinyl Estradiol

1. Teva Pharmaceutical Industries Ltd.

Overview: One of the largest generic pharmaceutical companies globally, Teva supplies a broad portfolio of hormonal APIs, including EE.
Capabilities: Teva's manufacturing facilities strictly adhere to GMP standards, with extensive experience in synthetic chemistry and API export.
Supply reliability: Known for consistent supply chains and competitive pricing, making Teva a preferred source for large-scale hormonal APIs.

2. Hetero Labs Limited

Overview: An Indian pharmaceutical manufacturer with a significant focus on hormone APIs, including EE.
Quality compliance: Hetero maintains GMP certification from global regulators, ensuring high-quality APIs.
Market positioning: Offers competitively priced bulk API with reliable supply volumes, aiding affordability.

3. Mylan (now part of Viatris)

Overview: Mylan's manufacturing facilities produce a range of hormonal APIs, including EE.
Regulatory adherence: Mylan APIs comply with international standards such as FDA and EMA.
Distribution: A global footprint assures broad distribution capabilities.

4. Dr. Reddy's Laboratories

Overview: An Indian pharmaceutical leader with robust API manufacturing capacity for EE.
Quality assurance: Ensures GMP standards and regulatory compliance.
Supply chain: Demonstrated reliability in global API supply during high-demand periods.

5. Sandoz (Novartis division)

Overview: Offers pharmaceutical-grade EE for various formulation needs.
Quality standards: Adheres to stringent GMP practices with high purity levels demanded in contraceptive applications.

Prominent Suppliers for Norelgestromin

Compared to EE, sourcing norelgestromin is more specialized given its complex synthesis and lower market penetration.

1. Jiangsu Hengrui Medicine Co., Ltd.

Overview: A leading Chinese API manufacturer with capabilities in progestin synthesis.
Product offerings: Supplies norelgestromin to global markets with GMP certification.
Quality: Consistent high-quality production aligned with international standards.

2. Gedeon Richter Plc.

Overview: Hungarian pharmaceutical firm with extensive experience in progestins.
API manufacturing: Produces high-purity norelgestromin for contraceptive formulations.
Market reach: Supplies via global distributors with reliable delivery.

3. Mylan (Viatris)

Overview: Also involved in norelgestromin production; integration with EE supply enhances supply chain flexibility.
Quality credentials: GMP-certified facilities ensure compliance.

4. Hetero Labs Limited

Overview: Provides norelgestromin APIs, leveraging their experience in hormonal synthesis.
Affordability: Competitive pricing and high-quality standards benefit large-scale manufacturing.

5. Other Niche Manufacturers

Small-scale or regional manufacturers in India, China, and Eastern Europe offering niche norelgestromin production. Their relevance depends on quality certifications and regulatory alignments.

Quality and Regulatory Considerations

Securing API sources for XULANE demands stringent evaluation of quality attributes and regulatory compliance:

GMP Certification: Required for all suppliers to ensure manufacturing adherence to international standards.
Regulatory Approvals: APIs must meet specifications approved by entities like the US FDA, EMA, or local regulators.
Purity and Consistency: High purity levels (>99%) are necessary to prevent adverse reactions or efficacy issues.
Stability and Packaging: APIs should be supplied in stabilized forms, with proper documentation for stability profiles.

Supply Chain Dynamics and Market Trends

Geopolitical Factors: Political stability, trade policies, and tariffs influence API sourcing decisions, especially for Chinese and Indian suppliers.
Manufacturing Capacity: Increased demand for hormonal APIs post-pandemic has prompted expansions and capacity enhancements.
Cost Considerations: Indian and Chinese manufacturers often offer lower-priced APIs due to lower labor and manufacturing costs, but regulatory and quality assurance rigor is critical.
Strategic Diversification: To mitigate risk, pharmaceutical companies diversify API sourcing across multiple suppliers and regions.

Conclusion

The supply chain for the APIs constituting XULANE hinges on a set of globally recognized, GMP-compliant manufacturers. Ethinyl estradiol suppliers such as Teva, Hetero, Mylan, Dr. Reddy’s, and Sandoz form the backbone for consistent, high-quality EE API sourcing. For norelgestromin, suppliers like Jiangsu Hengrui, Gedeon Richter, and Mylan are critical contributors. Companies must evaluate not only cost but regulatory compliance, quality assurance, and supply reliability to mitigate manufacturing and regulatory risks.

Key Takeaways

Sourcing high-quality API supplies for XULANE requires rigorous due diligence on GMP compliance, purity, and regulatory approvals.
Established multinationals like Teva, Hetero, and Mylan dominate API supply for EE, while niche suppliers fulfill NGMN demands.
Geopolitical, regulatory, and capacity factors influence API sourcing decisions; diversification is essential.
Cost advantages from Indian and Chinese suppliers must be balanced against quality assurance and regulatory compliance.
Staying abreast of manufacturing capacity expansions and compliance standards is vital for uninterrupted XULANE production.

FAQs

1. What are the primary considerations when selecting an API supplier for XULANE?
Quality assurance (GMP compliance), regulatory approvals, API purity, supply reliability, and cost are primary considerations. Ensuring supplier transparency and adherence to internationally recognized quality standards is paramount.

2. How does geopolitical stability impact API sourcing for contraceptive products like XULANE?
Geopolitical factors influence trade policies, tariffs, and export restrictions, which can disrupt supply chains. Diversifying suppliers across regions mitigates risks associated with geopolitical tensions.

3. Are there alternative sources for norelgestromin outside China and India?
Yes, suppliers in Europe and North America, such as Gedeon Richter or specialty contract manufacturers, provide norelgestromin, often with higher regulatory standards, though at potentially higher costs.

4. How does API purity affect the efficacy of the XULANE contraceptive patch?
High purity ensures consistent pharmacokinetics, minimizes adverse reactions, and maintains product efficacy—critical factors for contraceptive reliability.

5. What trends are shaping the future of API sourcing for hormonal contraceptives?
Increased capacity expansion, automation, regulatory harmonization, and quality assurance improvements aim to enhance supply chain robustness. Sustainability and supply chain transparency are also gaining importance.

References

[1] U.S. Food and Drug Administration (FDA). "Drug Master Files." FDA.gov, 2022.
[2] European Medicines Agency (EMA). "Guidelines on Good Manufacturing Practice." EMA.europa.eu, 2022.
[3] PharmSource. "API Market Trends and Supply Chain Updates." PharmSource.com, 2023.
[4] GlobalData. "Pharmaceutical APIs Market Report." GlobalData.com, 2023.
[5] IMS Health. "Hormonal API Supply Chain Analysis." IMS.com, 2022.

Bulk Pharmaceutical API Sources for XULANE