Suppliers and packagers for ESTARYLLA

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	ESTARYLLA	ethinyl estradiol; norgestimate	TABLET;ORAL-28	090794	ANDA	AvKARE	42291-553-84	3 CARTON in 1 CARTON (42291-553-84) / 1 BLISTER PACK in 1 CARTON (42291-553-28) / 1 KIT in 1 BLISTER PACK	2020-04-20
Xiromed	ESTARYLLA	ethinyl estradiol; norgestimate	TABLET;ORAL-28	090794	ANDA	Bryant Ranch Prepack	63629-2349-1	3 BLISTER PACK in 1 CARTON (63629-2349-1) / 1 KIT in 1 BLISTER PACK	2018-01-01
Xiromed	ESTARYLLA	ethinyl estradiol; norgestimate	TABLET;ORAL-28	090794	ANDA	Xiromed, LLC.	70700-119-85	3 BLISTER PACK in 1 CARTON (70700-119-85) / 1 KIT in 1 BLISTER PACK	2018-01-01
Xiromed	ESTARYLLA	ethinyl estradiol; norgestimate	TABLET;ORAL-28	090794	ANDA	Proficient Rx LP	82804-158-28	1 BLISTER PACK in 1 POUCH (82804-158-28) / 1 KIT in 1 BLISTER PACK	2018-01-01

Suppliers for the Pharmaceutical Drug: ESTARYLLA

Last updated: August 5, 2025

Introduction

ESTARYLLA is a combined hormonal contraceptive pill containing estradiol valerate (a form of estrogen) and dienogest (a progestin). Marketed primarily for contraception and hormone therapy, ESTARYLLA necessitates a complex supply chain driven by stringent manufacturing standards, regulatory compliance, and global distribution logistics. Identifying its key suppliers—ranging from active pharmaceutical ingredient (API) producers to finished drug manufacturers—is crucial for stakeholders across pharmaceutical development, supply chain management, and healthcare distributions.

Manufacturing and Supply Chain Overview

The production of ESTARYLLA involves several critical stages:

• Active Pharmaceutical Ingredient (API) Synthesis
• Formulation and Final Drug Manufacturing
• Packaging and Distribution

Each stage relies on specialized suppliers adhering to Good Manufacturing Practices (GMP), with sourcing often tied to strategic partnerships, regulatory approvals, and global logistics. The complexity of hormonal preparations amplifies the importance of high-quality, reliable suppliers.

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API Suppliers for Estrogen (Estradiol Valerate)

Estradiol valerate is the estrogen component in ESTARYLLA, synthesized through complex chemical processes, often involving asymmetric synthesis and esterification.

Leading API Manufacturers

1. Laboratorios del Dr. Serrano S.A.U.
   A Spain-based company specializing in steroid hormones, including estradiol derivatives. The firm supplies high-purity APIs to both regional and global pharmaceutical firms.

2. Bionpharma Inc.
   Located in the United States, Bionpharma is known for its robust portfolio of API production, including hormone-based compounds. They emphasize compliance with U.S. FDA standards, making their APIs suitable for global markets.

3. AbbVie (formerly Abbott Laboratories)
   As a major pharmaceutical player, AbbVie manufactures estradiol and its derivatives through subsidiaries with vertically integrated APIs, supplying patent-protected or generic hormone APIs.

4. Tapioca Chemicals Pvt. Ltd.
   An Indian manufacturer specializing in steroid hormones, with a focus on cost-effective, high-quality APIs meeting international standards.

5. Hubei Biocause Pharmaceutical Co., Ltd.
   A major Chinese manufacturer producing steroid hormones, including estradiol valerate, with widespread export markets.

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Progestin API Suppliers (Dienogest)

Dienogest is a synthetic steroidal progestin utilized widely in hormonal contraceptives.

Leading API Manufacturers

1. Bayer Pharma AG
   As the originator of dienogest, Bayer's API production is highly controlled and often supplied under strict licensing agreements for formulation use.

2. Hainan Yataifeng Pharmaceutical Co., Ltd.
   A Chinese manufacturer providing high-grade dienogest APIs compliant with international standards, often used for generic formulations.

3. Sundia Chemicals Pvt. Ltd.
   Based in India, Sundia supplies APIs, including dienogest, tailored for the global reproductive health market.

4. Zhejiang Hailir Pharmaceutical Co., Ltd.
   A notable Chinese API producer capable of large-scale production of dienogest, meeting global regulatory specifications.

5. Laboratorios Andromed?
   A Latin American supplier with a focus on hormonal APIs, including dienogest, catering to regional markets.

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Finished Dosage Formulators & Contract Manufacturing

The final formulation, packaging, and distribution of ESTARYLLA are often executed by contract manufacturing organizations (CMOs) or pharmaceutical companies with licensed production capacities.

Prominent formulators include:

• Gedeon Richter Plc. (Hungary)
  A major European pharmaceutical producer, manufacturing hormonal contraceptive products and engaging in OEM contracts.

• Cadila Healthcare Ltd. (India)
  Known for active engagement in generic hormonal contraceptives, including ESTARYLLA formulations.

• Pfizer Inc.
  In some markets, Pfizer partners with local CMOs to produce estrogen-progestin combination pills under license agreements.

• Teva Pharmaceuticals
  Certified for hormonal contraceptives, producing generic versions for global distribution.

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Regulatory and Quality Considerations

Suppliers for ESTARYLLA must ensure compliance with regulatory standards such as:

• FDA (U.S. Food and Drug Administration)
• EMA (European Medicines Agency)
• PMDA (Japan Pharmaceuticals and Medical Devices Agency)
• WHO GMP Certifications

High-quality API sourcing and manufacturing are essential to prevent adverse events, ensure product efficacy, and meet bioequivalence standards required for regulatory approval.

Geographic Distribution and Sourcing Trends

• Asia (India, China) dominates API manufacturing for hormone drugs due to cost efficiencies and large-scale production capacity.
• Europe and North America maintain stringent quality assurance, supplying APIs for branded and high-regulation markets.
• Emerging markets increasingly develop local manufacturing capabilities, reducing dependency on imports and affecting the global supply chain dynamics.

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Supply Chain Challenges and Market Dynamics

• Regulatory compliance remains a barrier to entry for new API producers.
• Global geopolitics and trade policies influence sourcing options, especially regarding API imports.
• Manufacturing capacity constraints and quality lapses can disrupt supply, contributing to market volatility.
• Patent landscapes and licensing agreements affect the availability of APIs for generic versions of ESTARYLLA.

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Conclusion

The supply chain for ESTARYLLA involves a complex web of specialized API manufacturers, contract formulators, and logistics partners, primarily focused in Asia, Europe, and North America. Reliable suppliers like Bayer (for dienogest), along with regional producers of estradiol valerate, are central to maintaining product stability and regulatory compliance. Businesses must carefully vet suppliers, monitor geopolitical risks, and ensure adherence to global standards to secure a resilient supply chain for ESTARYLLA.

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Key Takeaways

• Diverse API Sources: ESTARYLLA’s components are supplied by a mix of global and regional manufacturers, with dominant contributions from China, India, and Europe.
• Regulatory Stringency: Suppliers must comply with stringent GMP standards, underscoring the importance of regulatory alignment for market access.
• Supply Chain Risks: Dependence on Asian API manufacturers presents risks; diversification and strategic partnerships mitigate potential disruptions.
• Market Dynamics: Patent expiries and genericization influence sourcing trends, with increasing domestic manufacturing in emerging markets.
• Operational Focus: For stakeholders, rigorous supplier qualification, ongoing quality assurance, and geopolitical awareness are essential to secure uninterrupted supply.

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FAQs

1. Who are the largest API producers for estradiol valerate used in ESTARYLLA?
Major producers include Laboratorios del Dr. Serrano (Spain), Tapioca Chemicals (India), and Hubei Biocause (China). These firms supply high-purity APIs meeting international standards for hormonal drugs.

2. Is Bayer the primary supplier of dienogest for ESTARYLLA?
Yes. Bayer was the original developer of dienogest, and its licensing agreements influence the availability of high-quality APIs. However, other manufacturers in China and India now produce licensed and generic versions.

3. What are the main challenges in sourcing APIs for ESTARYLLA?
Key challenges include regulatory compliance, geopolitical risks impacting import/export, manufacturing capacity constraints, and maintaining consistent quality across supplier sources.

4. How do regulatory standards affect API suppliers for hormonal drugs like ESTARYLLA?
Suppliers must adhere to GMP, EMA, and FDA standards, ensuring API purity, stability, and manufacturing process integrity. Non-compliance risks product rejection and legal action.

5. Are there emerging suppliers or markets for ESTARYLLA components?
Yes. Countries like Vietnam, Mexico, and Brazil are developing local API manufacturing capabilities, which could diversify supply chains and foster regional production hubs.

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Sources:

[1] European Medicines Agency (EMA). "Guidelines on Good Manufacturing Practices."
[2] U.S. Food and Drug Administration (FDA). "Drug Establishments Inspection Guides," 2022.
[3] GlobalData. "Hormonal API Market Analysis," 2023.
[4] IMS Health. "Market Trends in Hormonal Contraceptives," 2023.
[5] Company websites and official filings from Bayer, Laboratorios del Dr. Serrano, and Tapioca Chemicals.