Suppliers and packagers for generic pharmaceutical drug: ulipristal acetate

ulipristal acetate

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: ULIPRISTAL ACETATE

Last updated: July 28, 2025

Introduction

Ulipristal Acetate, a selective progesterone receptor modulator (SPRM), is primarily used in emergency contraception and for the treatment of uterine fibroids. Its global demand has increased, prompting a detailed exploration of the key suppliers involved in its manufacturing and distribution. Analyzing the supply chain landscape provides insights for pharmaceutical companies, investors, and healthcare providers who seek to understand market dynamics, potential sourcing options, and competitive positioning.

Global Manufacturing Landscape of Ulipristal Acetate

The manufacturing of Ulipristal Acetate involves complex chemical synthesis processes that require high-level expertise and compliance with stringent regulatory standards. The primary suppliers span innovative pharmaceutical firms, generic drug manufacturers, and active pharmaceutical ingredient (API) producers. These suppliers often operate under licensing agreements with patent holders or develop their own synthesis routes once patents expire.

Key Pharmaceutical Companies Supplying Ulipristal Acetate

1. Gedeon Richter Plc.

Gedeon Richter, a Hungarian pharmaceutical major, is a pioneering producer of Ulipristal Acetate. In collaboration with pharmaceutical companies across Europe and Asia, Richter developed the drug under the brand name EllaOne for emergency contraception. Their manufacturing capacity is well-established, making them a leading API supplier globally. The company focuses on high-quality, compliant production aligned with EMA and FDA standards. Richter’s strategic partnerships have facilitated widespread distribution across Europe and parts of Asia.

2. Bionpharma Inc.

Bionpharma, a U.S.-based generic pharmaceutical manufacturer, emerged as a key supplier after acquiring rights for certain formulations of Ulipristal Acetate or related APIs. The company's focus on generic drugs and robust API synthesis capabilities make it a noteworthy player in North America. Bionpharma’s involvement typically centers around API manufacturing and formulation for regional markets.

3. Sun Pharmaceutical Industries Ltd.

This Indian pharmaceutical giant has diversified its portfolio, including the production of APIs like Ulipristal Acetate. Sun Pharma benefits from extensive manufacturing infrastructure, emphasizing cost-effective synthesis and global distribution. Their role often involves API supply to global generic drug manufacturers, especially targeting emerging markets.

4. Laboratorios Andrómaco and Other Regional Manufacturers

In Latin America, regional manufacturers such as Laboratorios Andrómaco and other local companies synthesize and distribute Ulipristal Acetate, often under licensing or third-party agreements. These firms focus on regional needs, shipping API to local pharmaceutical companies for formulation and final drug production.

API and Raw Material Suppliers

The production of Ulipristal Acetate hinges on the availability of high-purity raw materials and specialty chemicals. Suppliers of key intermediates and catalysts contribute to the supply chain's resilience. Major chemical producers, such as BASF and Eastman Chemical, supply raw materials utilized in the synthesis process, often tailored to the specifications of API manufacturers.

Manufacturing Challenges and Regulatory Considerations

Sourcing Ulipristal Acetate is fraught with challenges, including stringent quality standards mandated by the FDA, EMA, and other regulatory agencies. Suppliers must ensure compliance with Good Manufacturing Practice (GMP), robust quality control, and traceability. An interruption at any point in the supply chain can impact drug availability globally, emphasizing the importance of diversification among API suppliers.

Market Dynamics and Sourcing Strategies

The market landscape is influenced by patent statuses, with patents on EllaOne expiring or reaching expiry, paving the way for generic production. Companies often establish licensing agreements or develop in-house synthesis capabilities to capitalize on new market opportunities. Risk mitigation involves engaging multiple suppliers across different regions to avoid disruptions caused by geopolitical issues, regulatory changes, or supply chain inefficiencies.

Future Outlook

As demand for emergency contraception and uterine fibroid treatments increases, the need for reliable Ulipristal Acetate suppliers will grow. Ongoing research to optimize synthesis pathways and scale manufacturing will likely introduce new players into the supply chain. Additionally, patent expirations will accelerate generic entry, heightening competition among API suppliers and potentially affecting pricing and availability.

Key Players Summary

Company	Region	Role	Notable Highlights
Gedeon Richter	Europe	Primary API producer	Extensive manufacturing capacity, licensed global distribution
Bionpharma	North America	API supplier	Focus on generics, regional API manufacturing
Sun Pharma	India	API manufacturer	Cost-efficiency, global reach
Laboratorios Andrómaco	Latin America	Regional supplier	Focused on regional markets, licensing agreements

Conclusion

The procurement landscape for Ulipristal Acetate is characterized by a handful of dominant pharmaceutical companies and regional manufacturers, supported by specialized chemical suppliers. Ensuring a diversified supply chain remains critical for stakeholders to maintain uninterrupted access and meet regulatory standards. As the market evolves, new entrants and technological advancements in synthesis will influence the global supplier network.

Key Takeaways

• Leading suppliers include Gedeon Richter, Bionpharma, and Sun Pharma, each with distinct regional strengths and capacities.
• Regulatory compliance is paramount for API manufacturers, influencing supplier selection and supply chain stability.
• Patents' expiration fosters increased generic production, intensifying competition among suppliers and potentially lowering prices.
• Diversification of sources diminishes supply disruption risks, especially amid geopolitical or regulatory fluctuations.
• Innovation in synthesis methods promises to expand the supplier base, creating opportunities for new entrants and cost improvements.

Frequently Asked Questions (FAQs)

1. Who are the largest global producers of Ulipristal Acetate?
The largest producers include Gedeon Richter (Europe), Bionpharma (North America), and Sun Pharma (India), each with extensive manufacturing capacity and regional distribution agreements.

2. How does patent status influence supplier sources for Ulipristal Acetate?
Patent protections limit market entry, but expiration opens avenues for generic manufacturers, expanding the supplier pool and promoting competition and lower prices.

3. What regulatory standards do suppliers of Ulipristal Acetate need to meet?
Suppliers must adhere to GMP standards set by agencies like the FDA and EMA, ensuring API quality, stability, and consistency for pharmaceutical use.

4. Are there regional differences in Ulipristal Acetate suppliers?
Yes, regional manufacturers and regional chemical suppliers tailor their production to local markets, with global suppliers providing APIs for international markets.

5. What are future trends impacting suppliers of Ulipristal Acetate?
Enhanced synthesis techniques, regulatory shifts, patent expirations, and increased global demand are shaping the supplier landscape, encouraging diversification and innovation.

Sources:

1. European Medicines Agency (EMA). "Ulipristal acetate." Retrieved from [EMA website].
2. Gedeon Richter Plc. Corporate Publications.
3. Bionpharma Inc. Public filings.
4. Sun Pharmaceutical Industries Ltd. Annual Report 2022.
5. Market analysis reports on hormone modulating agents and APIs.