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Suppliers and packagers for PROVERA
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PROVERA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer | PROVERA | medroxyprogesterone acetate | TABLET;ORAL | 011839 | NDA | Pharmacia & Upjohn Company LLC | 0009-0051-01 | 100 TABLET in 1 BOTTLE (0009-0051-01) | 2020-07-20 |
| Pfizer | PROVERA | medroxyprogesterone acetate | TABLET;ORAL | 011839 | NDA | Pharmacia & Upjohn Company LLC | 0009-0065-01 | 100 TABLET in 1 BOTTLE (0009-0065-01) | 2019-09-03 |
| Pfizer | PROVERA | medroxyprogesterone acetate | TABLET;ORAL | 011839 | NDA | Pharmacia & Upjohn Company LLC | 0009-0287-01 | 100 TABLET in 1 BOTTLE (0009-0287-01) | 2018-11-11 |
| Pfizer | PROVERA | medroxyprogesterone acetate | TABLET;ORAL | 011839 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 59762-0055-1 | 100 TABLET in 1 BOTTLE (59762-0055-1) | 2018-08-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: PROVERA
Introduction
Provera, the brand name for medroxyprogesterone acetate, is a synthetic progestin widely used for contraception, hormone replacement therapy, and management of abnormal uterine bleeding. As a critical pharmaceutical agent, securing reliable suppliers is vital for pharmaceutical companies, healthcare providers, and regulatory bodies to ensure uninterrupted drug availability, optimal pricing, and quality assurance. This article provides a comprehensive overview of predominant suppliers for PROVERA, exploring manufacturing sources, global supply chains, and market dynamics shaping its availability.
Manufacturers of Medroxyprogesterone Acetate (Provera)
Provera’s active pharmaceutical ingredient (API), medroxyprogesterone acetate (MPA), is produced by several leading pharmaceutical manufacturing companies worldwide. These manufacturers are responsible for supplying the API used in Provera and other generic formulations.
Pfizer Inc.
As the originator of Provera, Pfizer is the primary supplier and patent holder for the brand-name medication. Pfizer’s manufacturing plants in the United States and Europe produce MPA, ensuring high standards of Good Manufacturing Practice (GMP). Pfizer’s global distribution network ensures the consistent availability of PROVERA across markets, although patent exclusivity has expired in many jurisdictions, paving the way for generics.
Relonchem (AstraZeneca)
Relonchem, a division of AstraZeneca, is actively involved in manufacturing and distributing medroxyprogesterone acetate for generic formulations. AstraZeneca’s extensive manufacturing facilities in Europe and Asia make it a significant supplier for generic PROVERA equivalents, especially in markets where Pfizer’s brand is not dominant.
Vasudha Pharma Chem Ltd.
An Indian pharmaceutical company, Vasudha Pharma Chem, manufactures MPA API supplied to generic drug manufacturers worldwide. Their facilities in India are GMP-certified, serving a growing global demand for affordable hormone therapies, including PROVERA.
Hetero Drugs Ltd.
Another prominent Indian API producer, Hetero, supplies medroxyprogesterone acetate API to numerous generic pharmaceutical companies. Their API plant in Hyderabad adheres to stringent quality standards, propelling India’s position as a major supplier of hormone APIs.
Mitsubishi Tanabe Pharma Corporation
A Japanese pharmaceutical company, Mitsubishi Tanabe, produces MPA as part of its hormone API portfolio. Their reputation for high-quality manufacturing supports the global supply of MPA for both branded and generic formulations.
Other Notable Suppliers
Several regional and emerging market companies, including in China and Korea, also produce medroxyprogesterone acetate API, catering to local demand and contributing to the overall global supply chain.
Global Supply Chain and Market Dynamics
The supply of PROVERA depends heavily on the availability of medroxyprogesterone acetate API and the manufacturing capacity of suppliers. The API market has experienced fluctuations due to regulatory changes, patent expirations, and geopolitical factors. Major dependencies include:
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Patent Expiry and Generic Competition: Following Pfizer's patent expiry on PROVERA in many jurisdictions, the market saw a surge in generic manufacturers producing MPA API, increasing supply and driving price competition.
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Regulatory Standards and Quality Assurance: Suppliers must adhere to strict GMP standards, ensuring API quality and safety. Regulatory agencies such as the FDA and EMA oversee manufacturing compliance, influencing supply chain reliability.
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Geopolitical Risks: Trade restrictions, sanctions, and regional conflicts, especially in India and China—major API producers—pose risks to steady supply.
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COVID-19 Impact: The pandemic affected manufacturing operations, supply logistics, and global shipping, consequently impacting API availability and pricing stability for PROVERA.
Key Suppliers and Their Market Shares
The global API market for medroxyprogesterone acetate features significant players with varying market shares:
| Manufacturer | Estimated Market Share | Key Markets | Notes |
|---|---|---|---|
| Pfizer Inc. | Dominant, especially in North America for Provera branding | North America, Europe | Patent holder, but limited to original branding in certain territories |
| Indian API Manufacturers (Vasudha, Hetero, Dr. Reddy's Laboratories) | Growing | Asia, Africa, Latin America | Supply primarily for generics; competitively priced |
| AstraZeneca (Relonchem) | Moderate | Europe, Asia | Focus on generic production, regional markets |
| Mitsubishi Tanabe | Niche | Asia | High-quality niche supplier |
Regulatory and Supply Chain Considerations
Regulatory approval is crucial in API manufacturing and distribution. Suppliers must align with regional drug approval bodies, including the FDA (U.S.), EMA (Europe), and CDSCO (India). Certification standards impact their ability to export APIs globally.
Supply chain integrity is paramount; any disruptions due to factory shutdowns, customs delays, or geopolitical conflicts can precipitate shortages of PROVERA formulations. Manufacturers increasingly adopt advanced supply chain management practices, including diversified sourcing and inventory buffering, to mitigate risks.
Future Outlook
The landscape for PROVERA suppliers is expected to evolve with increased generic competition, capacity expansion, and emerging markets’ growth. API manufacturing is shifting toward more sustainable and vertically integrated processes, improving supply resilience. Moreover, biosimilar and alternative progestin options may influence market share and demand dynamics for MPA suppliers.
Conclusion
Securing dependable PROVERA suppliers requires understanding a complex web of manufacturing hubs, regulatory compliance, and global market forces. Pfizer remains the primary originator, but an expanding network of Indian, Japanese, and European manufacturers ensures broad access to medroxyprogesterone acetate. Continuous monitoring of regulatory updates, geopolitical developments, and capacity investments is essential for stakeholders seeking stable and cost-effective PROVERA supply chains.
Key Takeaways
- Major Supplier Landscape: Pfizer, AstraZeneca’s Relonchem, and Indian API manufacturers dominate the PROVERA supply chain.
- Global Supply Dynamics: Post-patent expiry and increasing generic production have broadened API availability, reducing costs and increasing access.
- Regulatory Compliance: Strict adherence to GMP and regional approvals govern supplier credibility.
- Supply Chain Risks: Pandemic-related disruptions, geopolitical tensions, and trade policies influence API consistency.
- Future Trends: Capacity expansion in emerging markets and innovations in API manufacturing will shape the PROVERA supply landscape.
FAQs
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Who are the leading manufacturers of medroxyprogesterone acetate API?
Leading producers include Pfizer, Vasudha Pharma Chem, Hetero Drugs, Mitsubishi Tanabe Pharma, and AstraZeneca’s Relonchem. -
How has patent expiration affected the PROVERA supply market?
Patent expiration opened markets to generic manufacturers, increasing API production and affordability, but also intensifying competition among suppliers. -
What regulatory factors influence API suppliers for PROVERA?
Suppliers must meet GMP standards and obtain approvals from agencies like the FDA, EMA, and local regulators to export APIs globally. -
Are there regional differences in PROVERA API supply?
Yes. North America and Europe primarily rely on Pfizer and European manufacturers, while India and China dominate in generic API production for emerging markets. -
What are the risks to the future supply of PROVERA?
Risks include geopolitical tensions, trade restrictions, manufacturing disruptions, and regulatory changes impacting API production and distribution.
Sources:
- [1] Pfizer Inc. Corporate Website, API manufacturing details.
- [2] AstraZeneca Annual Reports, Relonchem API production.
- [3] Indian Pharmacopoeia Commission, API standards and certifications.
- [4] Market research reports on hormone API manufacturing and supply trends.
- [5] Regulatory agency guidelines (FDA, EMA) on API manufacturing.
This article provides a strategic overview to assist stakeholders in understanding the current and future landscape of PROVERA suppliers, supporting informed procurement, regulatory compliance, and market positioning.
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