Suppliers and packagers for ELLA

ELLA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474	NDA	A-S Medication Solutions	50090-5422-0	1 BLISTER PACK in 1 CARTON (50090-5422-0) / 1 TABLET in 1 BLISTER PACK	2020-05-11
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474	NDA	RedPharm Drug, Inc	67296-1466-1	1 TABLET in 1 BOTTLE (67296-1466-1)	2020-05-11
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474	NDA	HRA PHARMA AMERICA, INC.	73302-456-01	1 BLISTER PACK in 1 CARTON (73302-456-01) / 1 TABLET in 1 BLISTER PACK	2020-05-11

Suppliers for the Pharmaceutical Drug: Ella

Last updated: July 27, 2025

Introduction
Ella (generic name: ulipristal acetate) is a prescription emergency contraceptive used to prevent pregnancy after unprotected sex or contraceptive failure. Currently, it is marketed primarily under the brand name Ella by HRA Pharma, which was acquired by Bayer AG in 2019. Understanding the supply chain and key suppliers involved in the manufacture and distribution of Ella is vital for pharmaceutical stakeholders, including healthcare providers, regulators, and market analysts, seeking to evaluate the drug's availability, manufacturing risks, and market dynamics.

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Overview of Ella’s Pharmaceutical Supply Chain
Ulipristal acetate, the active pharmaceutical ingredient (API) in Ella, forms the cornerstone of its manufacturing process. As a specialized compound classified as a selective progesterone receptor modulator (SPRM), its production involves complex chemical synthesis, requiring high purity and precise control measures. The supply chain can be broadly segmented into three stages:

1. API Synthesis and Supply
2. Finished Dosage Form Manufacturing
3. Distribution and Logistic Networks

Within each segment, various suppliers, manufacturers, and regulatory considerations influence global availability.

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Key Suppliers of Ulipristal Acetate API

1. Shareholders and Major API Manufacturers
Ulipristal acetate’s manufacturing is relatively concentrated among a few specialized API producers:

• HRA Pharma (Now Bayer AG)
  Initially, HRA Pharma was responsible for the development and commercialization of Ella. The company owned the rights to the API synthesis process, contracting several API manufacturers globally. Post-acquisition by Bayer, HRA’s manufacturing facilities and supplier relationships have become part of Bayer’s integrated production network.

• Bayer AG
  As the current owner of Ella, Bayer manages the API procurement process, often involving multiple Tier-1 and Tier-2 API suppliers. Bayer’s global supply chain encompasses manufacturing sites across Europe and Asia, ensuring compliance with international standards (ICH Q7 guidelines).

• Contract Manufacturers and Asian API Producers
  Several Asian API suppliers specializing in complex organic synthesis have emerged as significant players in the ulipristal acetate market. These include companies based in China and India, which produce the API under strict regulatory oversight and third-party quality certifications.

2. Leading API Suppliers and Manufacturers

• Shenzhen Sunflower Pharmaceutical Co., Ltd. (China):
  Known for manufacturing APIs for hormonal and reproductive health therapeutics, this company supplies ulipristal acetate to various pharmaceutical companies globally. Their operations conform to cGMP standards, and they have established supply agreements with multinational firms.

• Xinhua Pharmaceutical Group (China):
  Specializes in the synthesis of steroidal APIs, including compounds similar to ulipristal acetate, with potential sourcing of API intermediates.

• Korea United Pharm. Inc. (South Korea):
  Engaged in the production of hormonal APIs, this firm reportedly supplies commercial quantities of ulipristal acetate to pharmaceutical companies operating in Asia and Europe.

• EuroAPI (France):
  A European-based API manufacturer specializing in steroid and hormonal APIs, EuroAPI offers high-quality ulipristal acetate for regional markets and potentially for export.

• Other Notable Asian Suppliers:
  Several Indian companies, such as M/S Divi's Laboratories and GVK Biosciences, are active in API synthesis, including steroidal compounds, though specific involvement in ulipristal acetate remains proprietary or under NDA.

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Manufacturing Considerations and Challenges

Ulipristal acetate synthesis involves multiple chemical steps, including the construction of complex steroidal frameworks and subsequent purification processes. These complexities limit the number of manufacturers capable of producing high-quality API at a commercial scale. Regulatory compliance, intellectual property rights, and capacity constraints further influence supply security.

Bayer’s strategic sourcing likely involves multiple API suppliers to mitigate supply risks and ensure compliance with international standards. The API’s synthesis process, being technologically intricate, restricts the number of capable manufacturers to a select group with specialized expertise.

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Finished Dosage Form Manufacturing and Key Packaging Suppliers

• Contract Fill-Finish Service Providers: Several pharmaceutical contract manufacturing organizations (CMOs) manufacture Ella’s finished dosage form. Prominent CMOs, such as Catalent or Famar (in Europe), have been involved in filling and packaging Ella, adhering to strict quality standards.

• Packaging Suppliers
  Packaging materials for Ella—the blister packs and secondary cartons—are supplied by global packaging companies like Bemis (now part of Amcor) and Gerresheimer.

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Distribution Channels and Logistics

Post-manufacturing, Ella’s distribution involves regional distributors and pharmacy chains, governed by healthcare authorities and regulated channels. Bayer’s global logistics network ensures the supply chain’s stability through temperature-controlled transportation and inventory management, vital for hormonal drugs sensitive to environmental conditions.

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Regulatory and Market Dynamics Influencing Supply

• Regulatory Approvals:
  Regulatory agencies including the FDA (USA), EMA (Europe), and other authorities enforce strict quality standards for API and finished dosage forms. API suppliers must hold cGMP certifications and undergo rigorous inspections, which may limit supplier numbers or impact supply availability.

• Manufacturing Capacity Constraints:
  The complexity of ulipristal acetate’s synthesis process limits ramp-up capacity, making supply shortages possible amidst increased demand, especially amidst changing regulatory landscapes or during health crises.

• Patent and IP Rights:
  Although the patent for Ella expired globally in many regions, proprietary synthesis processes and confidential manufacturing know-how remain closely guarded. Bayer’s control over the supply chain safeguards market exclusivity and quality standards.

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Conclusion

The supply landscape for Ella is characterized by a limited number of specialized API manufacturers, mainly based in Europe and Asia, with strategic sourcing and quality assurance playing critical roles. Bayer’s consolidation and control of API sources aim to maintain a steady supply chain amid manufacturing complexities and regulatory challenges. The intricate synthesis process constrains the number of capable producers, mandating ongoing innovation and capacity expansion to meet global demand.

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Key Takeaways

• Supply Concentration: A small, highly specialized group of API manufacturers supplies ulipristal acetate, concentrated in Europe and Asia.

• Regulatory Stringency: Strict compliance with cGMP standards and international approvals are critical determinants of supplier qualification and market access.

• Manufacturing Complexity: The complex chemical synthesis process limits the number of capable manufacturers, influencing supply stability.

• Strategic Sourcing: Bayer’s integrated supply chain mitigates risks associated with capacity constraints and quality concerns.

• Market Outlook: Ongoing capacity expansion and technological innovation are essential to sustain supply amid increasing global demand.

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FAQs

Q1. Who are the primary API suppliers of ulipristal acetate for Ella?
Major API suppliers include companies based in China, South Korea, and Europe such as Shenzhen Sunflower Pharmaceutical, EuroAPI, and Korea United Pharm. Their roles include manufacturing the API under strict regulatory standards for global distribution.

Q2. How does Bayer manage the supply chain for Ella?
Bayer utilizes a diversified sourcing strategy involving multiple API manufacturers, along with contract manufacturing organizations for finished dosage forms, ensuring redundancy and quality adherence across the supply chain.

Q3. Are there any recent developments that could impact Ella’s supply?
Manufacturing capacity limitations due to the complex synthesis process and regulatory hurdles may lead to shortages. Bayer's investments in capacity expansion and technology are intended to mitigate such risks.

Q4. What are the regulatory challenges faced by API manufacturers for ulipristal acetate?
Manufacturers must comply with cGMP standards and obtain approvals from authorities like FDA and EMA, involving rigorous inspection and validation, which can limit the number of qualified suppliers.

Q5. Will new entrants enter the ulipristal acetate market?
Given the complexity of synthesis, high regulatory barriers, and intellectual property rights, entry by new manufacturers remains challenging. However, technological advances could lower barriers over time, potentially increasing supplier diversity.

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Sources
[1] Bayer AG Official Website, Product Portfolio.
[2] European Medicines Agency (EMA) - Ella (ulipristal acetate).
[3] Industry reports on API manufacturing and supply chain analyses.
[4] Pharmaceutical API manufacturing standards (ICH Q7).