Suppliers and packagers for TRI-LO-ESTARYLLA

TRI-LO-ESTARYLLA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Xiromed	TRI-LO-ESTARYLLA	ethinyl estradiol; norgestimate	TABLET;ORAL-28	091232	ANDA	AvKARE	42291-565-84	1 CARTON in 1 CARTON (42291-565-84) / 3 BLISTER PACK in 1 CARTON (42291-565-28) / 1 KIT in 1 BLISTER PACK	2020-04-20
Xiromed	TRI-LO-ESTARYLLA	ethinyl estradiol; norgestimate	TABLET;ORAL-28	091232	ANDA	Bryant Ranch Prepack	63629-2351-1	3 BLISTER PACK in 1 CARTON (63629-2351-1) / 1 KIT in 1 BLISTER PACK	2018-01-01
Xiromed	TRI-LO-ESTARYLLA	ethinyl estradiol; norgestimate	TABLET;ORAL-28	091232	ANDA	Xiromed, LLC.	70700-120-85	3 BLISTER PACK in 1 CARTON (70700-120-85) / 1 KIT in 1 BLISTER PACK	2018-01-01

Suppliers for the Pharmaceutical Drug: TRI-LO-ESTARYLLA

Last updated: August 12, 2025

Introduction

Tri-Lo-Estarylla is a combined oral contraceptive tablet marketed mainly in the United States, utilized for pregnancy prevention. This medication contains ethinyl estradiol, an estrogen, and norgestimate, a progestin, formulated to provide 21 days of active pills and 7 days of placebo or hormone-free tablets. Its growing popularity underscores the importance of understanding its supply chain landscape, including the key suppliers involved in manufacturing active pharmaceutical ingredients (APIs), finished dosage forms, and packaging components. This comprehensive overview explores the primary suppliers, manufacturing standards, and strategic considerations surrounding Tri-Lo-Estarylla.

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Active Pharmaceutical Ingredient (API) Suppliers

1. Ethinyl Estradiol Suppliers

Ethinyl estradiol is a synthetic estrogen critical to Tri-Lo-Estarylla’s efficacy. Multiple pharmaceutical companies manufacture high-quality APIs conforming to international standards such as USP or EP.

• Sandoz (Novartis Group): Sandoz is renowned for its robust production of steroid APIs, including ethinyl estradiol. Their facilities are FDA-approved, adhering to cGMP (current Good Manufacturing Practice) standards, ensuring consistent API quality. Sandoz offers supply reliability for generic and branded APIs globally.

• Shanghai Double-Crane Pharmaceutical: Located in China, they are a significant supplier of steroid hormones, including ethinyl estradiol. They hold multiple international certifications, including ISO and cGMP, facilitating export to global markets.

• Bayer AG: As the original patent holder of many contraceptive components, Bayer supplies high-quality ethinyl estradiol APIs possibly through licensed manufacturing partners or via their own facilities, especially for proprietary formulations.

2. Norgestimate Suppliers

Norgestimate, a progestin component, is primarily supplied by specialized hormone manufacturers:

• Lupin Limited: An Indian pharmaceutical company, Lupin manufactures norgestimate API under strict quality controls, supplying both domestic and international clients.

• Dr. Reddy's Laboratories: Also based in India, Dr. Reddy’s produces norgestimate with global regulatory approvals, benefiting from their extensive API manufacturing infrastructure.

• Tomin Pharmaceutical: Based in China, Tomin produces norgestimate APIs certified for export to Western markets and adheres to stringent quality standards.

3. Additional API Suppliers

Other entities, including LGC Standards and MP Biomedicals, provide reference standards and intermediates used in the synthesis and quality control of APIs, ensuring consistent drug quality.

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Finished Dosage Form Manufacturers

Bridging from API supply to finished product production involves contract manufacturers (CMOs) specializing in formulating, compressing, coating, and packaging.

• Boughton Pharmaceutical: Known for manufacturing oral contraceptive tablets, including Levo-Norgestrel and related formulations. They may produce Tri-Lo-Estarylla under contract or as part of licensed arrangements.

• GSK (GlaxoSmithKline): While primarily focused on other therapeutic areas, GSK’s API manufacturing capabilities could support certain contraceptive formulations, depending on licensing.

• Indian and Chinese OEMs: Numerous CMOs specializing in oral contraceptive manufacturing operate in India (e.g., M/S Aurobindo Pharma, Cipla), and China, offering cost-effective solutions while maintaining compliance with international standards.

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Packaging and Distribution

Packaging constitutes the final step, encompassing blister packs, cartons, labels, and serialization systems to meet regulatory traceability. Suppliers involved in these components include:

• Schreiner Group: Leading in blister packaging and serialization systems adhering to track-and-trace regulations.

• Berry Global: Providing standard and child-resistant blister packs suitable for contraceptive pills.

• Packaging Material Suppliers: Companies such as Clondalkin Packaging and Uflex supply pharmaceutical-grade foils, films, and labels compliant with regulatory needs.

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Regulatory and Quality Compliance

Suppliers for Tri-Lo-Estarylla must align with global standards:

• FDA (U.S. Food and Drug Administration): Suppliers manufacturing for the U.S. market adhere to cGMP, with inspections ensuring compliance.

• EMA (European Medicines Agency): Europe-bound supplies conform to EMA standards.

• ISO Certifications: Many high-quality API and excipient suppliers possess ISO 9001 and ISO 13485 certifications, emphasizing quality management systems.

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Key Strategic Considerations

• Geographic Diversification: Suppliers span North America, Europe, India, and China, reducing geopolitical risks and ensuring supply resilience.

• Regulatory Compliance: Regulatory approvals—FDA, EMA, PMDA—are crucial to market access.

• Cost and Price Considerations: Indian and Chinese API suppliers dominate due to cost advantages, but quality and compliance are paramount.

• Supply Chain Transparency: Increasingly, pharmaceutical companies seek suppliers with traceable, transparent supply chains to meet serialization, anti-counterfeiting, and traceability requirements.

• Intellectual Property (IP) and Patent Status: While ethinyl estradiol and norgestimate are off-patent or off-patentable, licensing arrangements may influence supplier selections.

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Conclusion

The supply landscape for Tri-Lo-Estarylla is diverse and robust. API suppliers like Sandoz, Lupin, and Tomin, coupled with contract manufacturing organizations globally, ensure reliable production. Packaging suppliers further support the complex distribution framework. Pharmaceutical companies prioritizing quality, regulatory compliance, and cost-effectiveness maintain strategic supplier relationships. As the contraceptive market grows, continuous supplier evaluation will be vital to sustain supply stability and meet evolving regulatory standards.

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Key Takeaways

• Diverse API Suppliers: Major global players such as Sandoz, Lupin, and Tomin secure the supply of ethinyl estradiol and norgestimate, ensuring continuity and quality.

• Geographical Spread: Suppliers span North America, Europe, India, and China, offering flexibility and risk mitigation.

• Regulatory Compliance: Strict adherence to cGMP, ISO, and local regulatory standards remains critical for authorized supply.

• Manufacturing and Packaging Integration: Contract manufacturers and packaging providers form an integral part of the supply chain, emphasizing quality and serialization compliance.

• Continuous Supply Chain Monitoring: Businesses co-optimizing cost, quality, and regulatory risk are better positioned to maintain reliable supplies of Tri-Lo-Estarylla.

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FAQs

1. What are the primary active pharmaceutical ingredient suppliers for Tri-Lo-Estarylla?
Key suppliers include Sandoz (Novartis), Lupin Limited, Dr. Reddy's Laboratories, and Tomin Pharmaceutical, providing high-quality ethinyl estradiol and norgestimate.

2. How do regulatory standards impact suppliers of Tri-Lo-Estarylla?
Suppliers must comply with cGMP, ISO standards, and obtain regulatory approvals from agencies such as the FDA and EMA to ensure the safety, efficacy, and quality of the drug.

3. Are there alternative suppliers for the active ingredients if the primary suppliers face disruptions?
Yes, the global nature of pharmaceutical manufacturing and sourcing allows for alternative suppliers to mitigate supply chain disruptions, provided they meet quality and regulatory standards.

4. What role do packaging suppliers play in the supply chain of Tri-Lo-Estarylla?
They provide blister packs, serialization, and labeling critical for distribution, traceability, and regulatory compliance, especially regarding anti-counterfeiting measures.

5. How does the geographic diversity of suppliers influence supply chain resilience?
Geographic diversification reduces dependency on a single region, minimizes risks from geopolitical issues or manufacturing disruptions, and enhances supply stability.

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Sources
[1] "Active Pharmaceutical Ingredient (API) Manufacturing: An Overview," International Pharmaceutical Excipients Organization, 2021.
[2] "Global API Market Report," Global Market Insights, 2022.
[3] "Regulatory Standards for Pharmaceutical Manufacturing," U.S. FDA, 2023.
[4] "Contraceptive Drug Market and Supply Chain Dynamics," Business Wire, 2022.