Suppliers and packagers for PROMETRIUM

PROMETRIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Acertis Pharms	PROMETRIUM	progesterone	CAPSULE;ORAL	019781	NDA	Acertis Pharmaceuticals, LLC	72989-372-30	30 CAPSULE in 1 BOTTLE (72989-372-30)	2022-11-01
Acertis Pharms	PROMETRIUM	progesterone	CAPSULE;ORAL	019781	NDA	Acertis Pharmaceuticals, LLC	72989-373-30	30 CAPSULE in 1 BOTTLE (72989-373-30)	2022-11-01

Suppliers for the Pharmaceutical Drug: PROMETRIUM

Last updated: July 31, 2025

Introduction

PROMETRIUM, the brand name for the hormone progesterone, is primarily employed in reproductive medicine, including pregnancy maintenance, luteal phase support, and hormone replacement therapy. As a critical pharmaceutical, its supply chain involves various manufacturers, distributors, and licensing entities globally. Understanding the landscape of suppliers for PROMETRIUM is vital for stakeholders across healthcare, pharmaceuticals, and supply chain management to ensure consistent availability, regulatory compliance, and strategic procurement.

Manufacturing Landscape of PROMETRIUM

Prometrium® (the branded version) was historically produced by laboratories like Solvay Pharmaceuticals, now part of Johnson & Johnson under its Janssen Pharmaceuticals portfolio. However, the generic markets have expanded, with several manufacturers producing bioequivalent versions of progesterone.

Key Manufacturer Profiles

1. AbbVie
   AbbVie historically produced Prometrium in the United States under license from medicinal patent holders. Their manufacturing facilities meet stringent U.S. Food and Drug Administration (FDA) standards, ensuring high-quality supply.

2. Mylan / Viatris (formerly Mylan Pharmaceuticals)
   Mylan became a significant player with generic versions of progesterone, including oral capsules. Post-merger to Viatris, the company continues to supply progesterone generics across multiple markets, including North America and Europe.

3. MSD (Merck & Co.)
   Merck supplies progesterone products in the US and Europe, often through branded formulations and as part of collaborative licensing agreements.

4. Fougera Pharmaceuticals
   Now part of Mylan/Viatris, Fougera historically produced compounded progesterone formulations and licensed generics, supporting pharmacy compounding and mass manufacturing.

5. Teva Pharmaceutical Industries
   Teva produces various hormones and reproductive products, including bioequivalent progesterone formulations, especially in markets like Europe and the Middle East.

6. Sandoz (Novartis)
   Sandoz offers biosimilar and generic hormone products, including progesterone-based therapies, in select markets.

7. Hubei Biocause Pharma Co., Ltd. / Other Chinese Manufacturers
   Chinese pharmaceutical firms have entered the progesterone production space, supplying markets with bulk active ingredients and finished medications, often at lower costs but with variable regulatory acceptance outside Asia.

Active Pharmaceutical Ingredient (API) Suppliers

The backbone of PROMETRIUM’s supply chain is its API—bioidentical progesterone. Major API suppliers include:

• Thermo Fisher Scientific
  Provides high-purity progesterone APIs, adhering to international quality standards.

• Wuhan Bailing Biotechnology Co. Ltd.
  A Chinese API manufacturer supplying progesterone raw material globally, often used in generics.

• Sichuan Yuanda Bio-Pharmaceutical Co., Ltd.
  Focuses on hormone API production, including progesterone, for both domestic and export markets.

• BASF (through contract manufacturing)
  Has advanced facilities for hormone API synthesis, supporting large-scale global supply.

Regulatory and Quality Considerations

Suppliers must comply with regulatory standards set by the FDA, EMA, or other regional agencies. Product registration, GMP compliance, and batch consistency are critical for legitimacy in regulated markets. As a result, many manufacturers attain approvals like FDA ANDA (Abbreviated New Drug Application) or EMA centralized marketing authorization.

Distribution and Supply Chain Dynamics

Distribution channels for PROMETRIUM include:

• Pharmaceutical wholesalers and distributors: Entities like McKesson, Cardinal Health, and local distributors facilitate access across hospitals, clinics, and pharmacies.

• Direct manufacturer-to-pharmacy supply: Some large manufacturers engage directly with healthcare providers, ensuring product integrity and timely delivery.

• Compounding pharmacies: In certain regions, compounded progesterone formulations supplement commercial supplies, especially where generic options are unavailable.

Market Trends and Future Outlook

The global demand for progesterone-based therapies remains steady, driven by an increasing prevalence of infertility, IVF procedures, and hormonal deficiency treatments. The entry of low-cost API suppliers from China and India has heightened competition, influencing market pricing and availability. Moreover, patent expirations of branded products and regulatory approvals of generics have expanded supplier diversity.

Strategic Implications for Stakeholders

• Healthcare providers should prioritize suppliers with verified regulatory compliance and high-quality standards.
• Manufacturers seeking to enter or expand in the progesterone supply chain need to establish partnerships with API producers offering GMP-certified materials.
• Policymakers and regulators should monitor API quality and supply stability, especially for generics sourced from emerging markets.

Conclusion

The network of PROMETRIUM suppliers encompasses a broad spectrum ranging from proprietary brand manufacturers like Abbott and MSD to diverse generic producers and API suppliers across North America, Europe, and Asia. Ensuring a resilient supply chain involves selecting suppliers with robust regulatory compliance, reliable production capacity, and competitive pricing. As demand for progesterone therapies persists and evolves, supply chain agility and quality assurance remain pivotal for stakeholders aiming to sustain access.

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Key Takeaways

• Prometrium and generic progesterone products are supplied by leading pharmaceutical companies, with primary manufacturing in North America, Europe, and Asia.
• API suppliers such as Thermo Fisher and Chinese manufacturers play a critical role in the supply chain; their regulatory status impacts global distribution.
• Regulatory compliance (FDA, EMA) and GMP standards are essential for supplier credibility; ongoing quality assessments are necessary.
• The market's competitive landscape is shaped by patent expirations and the entry of low-cost API producers, influencing pricing and supply stability.
• Strategic procurement should focus on supplier reliability, product quality, and adherence to regional regulatory standards to ensure uninterrupted access.

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FAQs

1. Who are the main manufacturers of PROMETRIUM in the United States?
   AbbVie and Mylan (now Viatris) are primary manufacturers producing the branded and generic versions, with manufacturing facilities compliant with FDA standards.

2. What are the primary sources of progesterone API globally?
   Leading API providers include Thermo Fisher Scientific, Wuhan Bailing Biotech, Sichuan Yuanda Bio-Pharmaceutical, and contract manufacturers like BASF.

3. Are Chinese manufacturers a reliable source for progesterone API?
   Many Chinese factories comply with international GMP standards and supply APIs globally. However, quality assurance and regulatory approval need verification for each supplier.

4. How does the supplier landscape impact the availability of PROMETRIUM?
   A diverse supplier base enhances supply resilience, while reliance on a limited number of high-quality manufacturers could pose risks if disruptions occur.

5. What regulatory considerations should buyers evaluate when sourcing PROMETRIUM?
   Buyers should verify that all suppliers hold appropriate regulatory approvals (FDA, EMA), adhere to GMP standards, and provide consistency in quality and supply.

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Sources

[1] Market analysis reports on hormone pharmaceuticals.
[2] Company websites and press releases of AbbVie, Mylan, MSD, and others.
[3] Regulatory agency databases (FDA, EMA) for approval statuses.
[4] Industry journals on API manufacturing and supply chain dynamics.