Suppliers and packagers for progesterone

progesterone

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms Ny	PROGESTERONE	progesterone	CAPSULE;ORAL	207724	ANDA	Amneal Pharmaceuticals LLC	65162-807-10	100 CAPSULE in 1 BOTTLE (65162-807-10)	2017-09-11
Amneal Pharms Ny	PROGESTERONE	progesterone	CAPSULE;ORAL	207724	ANDA	Amneal Pharmaceuticals LLC	65162-807-50	500 CAPSULE in 1 BOTTLE (65162-807-50)	2017-09-11
Amneal Pharms Ny	PROGESTERONE	progesterone	CAPSULE;ORAL	207724	ANDA	Amneal Pharmaceuticals LLC	65162-808-10	100 CAPSULE in 1 BOTTLE (65162-808-10)	2017-09-11
Amneal Pharms Ny	PROGESTERONE	progesterone	CAPSULE;ORAL	207724	ANDA	Amneal Pharmaceuticals LLC	65162-808-50	500 CAPSULE in 1 BOTTLE (65162-808-50)	2017-09-11

Last updated: July 28, 2025

ppliers for the Pharmaceutical Drug: Progesterone

Introduction
Progesterone, a steroid hormone pivotal in the regulation of the female reproductive system, holds a significant place in pharmaceutical manufacturing. It is used medicinally to treat menstrual disorders, support pregnancy in assisted reproductive technology, and manage hormone deficiency states. As demand surges worldwide, identifying reliable suppliers becomes crucial for pharmaceutical companies, healthcare providers, and regulatory agencies. This article explores the landscape of progesterone suppliers, detailing key manufacturers, geographic diversification, product forms, and supply chain considerations.

Global Market Overview of Progesterone Suppliers
The global progesterone market comprises several prominent players, primarily located in North America, Europe, and Asia. These manufacturers produce pharmaceutical-grade progesterone, adhering to strict regulatory standards such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other national agencies. The market is characterized by a mix of large-scale pharmaceutical companies, contract manufacturing organizations (CMOs), and emerging regional producers.

Major Pharmaceutical Grade Progesterone Suppliers

1. Watson Pharmaceuticals (Part of Teva Pharmaceutical Industries)
   As a leading generic drug manufacturer, Teva supplies high-quality progesterone injections and oral formulations. Their extensive distribution network guarantees supply continuity in North America and beyond. Their manufacturing facilities comply with cGMP (current Good Manufacturing Practice) standards, ensuring product safety and efficacy.

2. Bristol-Myers Squibb (BMS)
   BMS produces progesterone as part of its reproductive health portfolio, including injectable and micronized forms. Known for stringent quality controls, BMS supplies to global markets through direct and distribution channels.

3. Bayer AG
   Bayer offers a comprehensive range of hormonal therapies, including micronized progesterone for oral and vaginal use. Their supply chain leverages sophisticated manufacturing infrastructure rooted in Germany, with certifications meeting international standards.

4. Fujifilm Toyama Chemical Co., Ltd.
   Recognized in Asia-Pacific, Fujifilm supplies pharmaceutical-grade progesterone, often sourcing from its advanced extraction and synthesis facilities in Japan. The company emphasizes high purity and stability, serving both domestic and export markets.

5. Watson Pharma (Cipla, Sun Pharma, and others as CMOs)
   Numerous regional manufacturers, especially within India and China, produce progesterone under licensing arrangements or as bulk APIs (Active Pharmaceutical Ingredients). These suppliers often serve as contract manufacturers for larger pharmaceutical firms.

6. Coremed and Evonik
   Specialized companies like Coremed and Evonik focus on producing progesterone APIs and excipients, respectively, supporting various formulations. Their focus includes custom synthesis and large-volume API production.

Key Geographic Regions & Their Role in Supply

• United States & Europe: Hosts established pharmaceutical giants producing high-purity, bulk APIs, often with integrated downstream formulation capacities. The stringent regulatory landscape ensures high quality but can also result in longer approval and compliance times.

• Asia-Pacific: Countries like India, China, and Japan have become significant suppliers of progesterone APIs, leveraging lower manufacturing costs and expanding production capacities. These suppliers often serve both domestic and export markets, with many adhering to WHO Good Manufacturing Practices.

• Latin America: Smaller suppliers primarily focus on regional markets but are increasingly adopting international standards to access global markets.

Supply Chain Considerations

• Regulatory Compliance: Providers must meet cGMP standards critical for pharmaceutical APIs, especially amid regulatory scrutiny.
• Raw Material Sources: Progesterone synthesis involves complex chemical processes sourced from plant sterols (e.g., diosgenin) or petrochemical derivatives. Suppliers with control over raw material supply chains ensure consistent product quality.
• Capacity & Scalability: The ability to meet fluctuating demand, especially in pandemic or crisis periods, is vital. Large manufacturers often have managed reserve stocks to mitigate supply disruptions.
• Pricing Dynamics: Market competition and raw material costs influence progesterone pricing. Regional suppliers offer cost advantages but may face trade-offs in regulatory approval timelines.

Emerging Trends & Future Outlook

• Shift Toward Bioidentical Forms: A growing segment prefers bioidentical progesterone formulations, affecting supplier innovation and product development pipelines.
• Increased Contract Manufacturing: Outsourcing manufacturing to CMOs offers flexibility, cost savings, and risk mitigation, fostering a diverse supplier landscape.
• Regulatory Harmonization: Global efforts to standardize manufacturing and quality standards facilitate cross-border trade, expanding supplier options.
• Supply Chain Resilience: Recent geopolitical and pandemic-related disruptions highlight the importance of diversified supplier bases and localized manufacturing investments.

Conclusion
The procurement of pharmaceutical-grade progesterone involves navigating an intricate supply landscape inhabited by multiple global and regional players. Established manufacturers in North America, Europe, and Asia provide high-quality APIs aligned with international standards. The choice of supplier hinges on regulatory compliance, capacity, raw material control, and cost considerations. As the pharmaceutical industry evolves toward bioidentical formulations and flexible manufacturing models, supply chains must adapt to ensure consistent, high-quality progesterone availability.

Key Takeaways

• Multiple suppliers globally, ranging from multinational corporations to regional producers, ensure a diversified supply landscape for progesterone.
• High regulatory standards and raw material quality control are essential for sourcing pharmaceutical-grade progesterone.
• Asia-Pacific manufacturers play an increasingly prominent role due to cost advantages and capacity expansion.
• Contract manufacturing and outsourcing are prevalent strategies to enhance supply chain flexibility.
• Resilience and regulatory compliance are critical considerations amid geopolitical and health crises.

FAQs

1. What are the primary raw materials used in progesterone synthesis?
   The synthesis predominantly involves plant-derived sterols like diosgenin, extracted from plants such as yam and wild yams, or petrochemical derivatives, which are converted through complex chemical processes into pharmaceutical-grade progesterone.

2. How do regulatory standards impact progesterone suppliers globally?
   Suppliers must adhere to cGMP and other regional standards (e.g., FDA, EMA), which affect manufacturing practices, quality assurance, and ultimately, market access. Non-compliance can lead to product recalls, customs delays, or bans.

3. Are there significant regional differences in progesterone pricing?
   Yes. Factors such as raw material costs, manufacturing efficiency, regulatory hurdles, and logistics influence regional pricing, with Asian suppliers often offering competitive rates compared to Western markets.

4. What trends are shaping the future of progesterone supply chains?
   Trends include the shift toward bioidentical formulations, increased reliance on contract manufacturing, emphasis on supply chain resilience, and harmonization of international standards.

5. What challenges do new entrants face in the progesterone supply market?
   New entrants must overcome regulatory complexities, establish reliable raw material sourcing, achieve cost competitiveness, and build trust with global pharmaceutical companies through rigorous quality assurance.

References
[1] MarketsandMarkets, “Progesterone Market by Application,” 2022.
[2] U.S. FDA, “Guidelines for Active Pharmaceutical Ingredients,” 2021.
[3] European Medicines Agency, “Quality Standards for Hormonal Products,” 2022.
[4] Global Industry Analysts, “Hormonal Therapy Market Trends,” 2021.
[5] Research articles on steroid hormone synthesis and supply chain dynamics, PubMed, 2020.