Bulk Pharmaceutical API Sources for PROMETHEGAN

Bulk Pharmaceutical API Sources for PROMETHEGAN

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		P4651_SIGMA
Molport		MolPort-003-666-272
Hangzhou APIChem Technology		AC-12482
Amadis Chemical		A831833
TimTec		ST51015100

Bulk Active Pharmaceutical Ingredient (API) Sources for: PROMETHEGAN

Last updated: August 6, 2025

Introduction

Promethegan, known generically as megesterol acetate, is a synthetic steroid used primarily in the treatment of hormone-responsive cancers, endometrial hyperplasia, and in hormone therapy. As with all pharmaceutical manufacturing, sourcing high-quality bulk active pharmaceutical ingredients (APIs) like megesterol acetate is critical for ensuring product efficacy, safety, and regulatory compliance. This article provides an authoritative overview of bulk API sources for Promethegan, examining the market landscape, key suppliers, and supply chain considerations, along with strategic insights for pharmaceutical companies.

Understanding Megesterol Acetate: The API Backbone of Promethegan

Megesterol acetate is a progestin hormone derivative, chemically characterized as 17α-acetoxy-6-methyl-6-phenyl-pregna-4,9-diene-3,20-dione. Its synthesis involves complex multi-step processes that require high-purity intermediates and advanced chemical manufacturing capabilities. The API’s quality standards are governed by pharmacopeias such as the USP, EP, and JP, emphasizing stringent impurity profiles, particle size specifications, and stability parameters. Ensuring reliable access to pharmaceutical-grade megesterol acetate is thus crucial for formulation integrity.

Global Market Dynamics for Megesterol Acetate API

The global API market for megesterol acetate is relatively niche, driven by the limited number of manufacturers with expertise in steroid synthesis. Despite its specialized application, market dynamics influence the availability and pricing of the API. Factors impacting supply include:

• Regulatory Barriers: Manufacturing facilities must comply with Good Manufacturing Practices (GMP), limiting the number of qualified producers.
• Raw Material Availability: The synthesis depends on complex raw materials and intermediates, often sourced from specialized suppliers.
• Market Demand Fluctuations: Limited use in select oncology and gynecology indications leads to relatively stable but small-volume procurement patterns.
• Geopolitical & Trade Policies: Export restrictions and tariffs may impact supply, especially from key manufacturing regions such as China and India.

Leading API Suppliers and Manufacturers

Pharmaceutical industry leaders and specialized chemical manufacturers dominate the supply landscape for megesterol acetate. Based on recent market intelligence, the key API producers include:

1. Jiangsu Hengrui Medicine Co., Ltd. (China)

A major Chinese pharmaceutical firm with extensive steroid API manufacturing capabilities, Hengrui supplies megesterol acetate both domestically and internationally. Their GMP certifications and international quality standards make them a trusted source within the Asian API market.

2. Zhongxi Pharmaceutical Co., Ltd. (China)

Recognized for steroid hormone intermediates and APIs, Zhongxi offers megesterol acetate with a focus on high purity and consistent batch quality, serving both Chinese domestic and export markets.

3. Prochemical & Dye Stuffs Ltd. (India)

A prominent Indian API manufacturer specializing in hormone APIs, Prochemical produces megesterol acetate under strict GMP conditions, supplying to global markets including North America and Europe.

4. Chinese and Indian API Contract Manufacturing Organizations (CMOs)

Multiple CMOs with licensed facilities in China and India have capabilities to produce megesterol acetate, often offering bulk procurement agreements for market entrants and generic drug manufacturers.

5. European and North American Suppliers

While fewer in number owing to stringent regulatory environments, certain European CMOs and North American intermediates suppliers either produce or source megesterol acetate through licensed manufacturing. However, procurement may involve lengthy qualification processes.

Regulatory and Quality Considerations

API procurement for Promethegan mandates compliance with regulatory authorities’ standards such as the FDA (USA), EMA (Europe), and other regional agencies. Suppliers must provide comprehensive documentation including:

• Certificates of Analysis (CoA)
• GMP Certificates
• Batch Records and Stability Data
• Impurity Profiles
  Given the critical role of API quality, buyers should verify supplier qualification through audits, review batch consistency, and assess impurity profiles, especially related to steroid synthesis.

Supply Chain & Risk Management Strategies

In sourcing megesterol acetate API, companies should consider the following:

• Dual Sourcing: Establish relationships with multiple qualified suppliers to mitigate supply disruptions.
• Long-term Contracts: Secure supply agreements to lock in pricing and ensure priority access during shortages.
• Supplier Qualification & Audits: Conduct thorough assessments of manufacturing capabilities, capacity, and compliance standards.
• Inventory Buffering: Maintain safety stocks to prevent production delays due to sudden supply chain interruptions.
• Regional Logistics Planning: Consider geographic factors impacting transit times, customs clearance, and geopolitical risks.

Emerging Trends and Future Outlook

As demand for hormone therapies persists, and pipeline drugs potentially expand indications, the demand for megesterol acetate API may grow modestly. Advances in synthetic chemistry could enable alternative manufacturing routes, potentially increasing supply scalability. Furthermore, stricter regulatory environments and quality standards will continue shaping supplier qualification requirements, favoring established, GMP-certified producers.

Conclusion

Reliable sourcing of bulk API for Promethegan (megesterol acetate) hinges on identifying qualified manufacturers with proven compliance, consistent quality, and supply stability. Top-tier Chinese and Indian API producers dominate the landscape, supported by a few specialized Western suppliers. Strategic sourcing, rigorous qualification, and proactive supply chain management are essential for pharmaceutical developers and generic manufacturers aiming to maintain uninterrupted access to this critical API.

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Key Takeaways

• Megesterol acetate API is primarily supplied by GMP-certified manufacturers in China and India, with strict quality and regulatory standards.
• Building diversified supplier relationships and establishing long-term contracts mitigate supply risks in a niche market.
• Rigorous qualification, quality audits, and comprehensive documentation are necessary to ensure API compliance and product integrity.
• Supply chain resilience and regional logistics planning are critical to maintaining a stable API supply.
• Market and regulatory developments suggest steady demand growth, requiring proactive sourcing strategies for sustained supply.

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FAQs

1. What are the primary global suppliers of megesterol acetate API?
Leading suppliers include Jiangsu Hengrui Medicine (China), Zhongxi Pharmaceutical (China), and Prochemical & Dyes Ltd. (India), all operating GMP-certified facilities capable of producing high-purity megesterol acetate.

2. How can pharmaceutical companies ensure API supply continuity for Promethegan?
Companies should establish relationships with multiple qualified suppliers, negotiate long-term contracts, perform qualification audits, maintain safety stock levels, and closely monitor geopolitical and regulatory changes affecting supply chains.

3. What are the key quality considerations when sourcing megesterol acetate API?
Key considerations include adherence to Good Manufacturing Practices, validation of impurity profiles, batch-to-batch consistency, stability data, and comprehensive documentation for regulatory compliance.

4. Are there synthetic alternatives or improved manufacturing routes for megesterol acetate?
While current manufacturing relies on complex steroid synthesis, ongoing research in synthetic methodologies may lead to more scalable or cost-effective routes, although widespread adoption is yet to materialize.

5. What regulatory challenges are associated with sourcing megesterol acetate API?
Regulatory challenges include ensuring manufacturer compliance with GMP standards, providing complete documentation, managing export/import restrictions, and maintaining C of A and stability data for regulatory audits.

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Sources:

[1] Market intelligence on steroid APIs and global manufacturer profiles.

[2] Regulatory guidelines from FDA and EMA for API manufacturing standards.

[3] Industry reports on Chinese and Indian API manufacturing capabilities.