MEGESTROL ACETATE: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novitium Pharma	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	077404	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1038-00	10 TRAY in 1 CASE (0121-1038-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1038-10)	2025-10-17
Novitium Pharma	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	077404	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1038-40	4 TRAY in 1 CASE (0121-1038-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1038-10)	2025-10-17
Novitium Pharma	MEGESTROL ACETATE	megestrol acetate	SUSPENSION;ORAL	077404	ANDA	ANI Pharmaceuticals, Inc.	70954-896-10	240 mL in 1 BOTTLE (70954-896-10)	2024-07-02
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Megestrol acetate is a synthetic progestin widely used in the management of appetite stimulation in cachexia, weight loss in HIV/AIDS patients, and hormone therapy for certain cancers, including endometrial and breast cancers. Its global demand has prompted a robust supply chain comprising manufacturers, generic producers, and chemical suppliers. Understanding the landscape of suppliers for megestrol acetate is essential for pharmaceutical companies, healthcare providers, and investors aiming to ensure supply security and evaluate market dynamics.

Market Landscape and Key Suppliers

The primary suppliers of megestrol acetate span across chemical manufacturers that produce active pharmaceutical ingredients (APIs), downstream drug formulators, and bulk drug distributors. The supply chain is characterized by geographic diversity, regulatory certifications, and varying capacities.

Major API Manufacturers

The foundational layer of the megestrol acetate supply chain involves API producers who synthesize the compound through complex chemical processes, often proprietary or licensed. Several global pharmaceutical and chemical companies are recognized as significant API suppliers:

Hunan Xiangzhong Pharmaceutical Co., Ltd. (China): A prominent producer of generic active pharmaceutical ingredients, including megestrol acetate. Known for large-scale manufacturing compliant with international quality standards such as cGMP (current Good Manufacturing Practice).
Guangzhou Hangson Pharmaceutical Co., Ltd. (China): Focused on the production of hormone APIs, including progestins like megestrol acetate, supplying both domestic and international markets.
Mannkind Corporation (USA): While mainly known for inhaled therapeutics, some of their subsidiaries or partnered manufacturers have capabilities in hormone API synthesis, including megestrol derivatives.
Indian API Manufacturers: Companies such as Hetero Labs Limited, Aurobindo Pharma, and Cipla have scaled-up production of hormone APIs, including generic megestrol acetate, mainly for the domestic Indian market and exportation.

Generic and Finished Dosage Form Manufacturers

Once APIs are produced, they are formulated into dosage forms by pharmaceutical companies. Key manufacturers of finished megestrol acetate products include:

Pfizer Inc.: Historically, Pfizer has supplied megestrol acetate in branded formulations such as Megace. Although some formulations have been off-patent, Pfizer's global manufacturing infrastructure remains a critical supplier source for bulk and finished products.
Elder Pharmaceuticals (India): Offers generic formulations of megestrol acetate, primarily targeting emerging markets.
Sun Pharmaceutical Industries Ltd. (India): Produces generic hormone therapies, including megestrol acetate tablets, for regional and export use.
Mylan/Novartis (Global): Has supplied generic megestrol acetate formulations in multiple regions, competing with branded products.

Chemical and Intermediate Suppliers

These suppliers focus on raw materials and intermediates used in chemical synthesis:

Thermo Fisher Scientific and Sigma-Aldrich (Merck Group): Offer chemical reagents and intermediates that are critical in the synthesis of megestrol acetate, including precursor compounds and solvents.
BASF and Dow Chemical: Provide specialty chemicals and catalysts used in multi-step manufacturing processes for hormone synthesis.

Regulatory and Certification Considerations

Suppliers operating in highly regulated regions such as the US, EU, and Japan are required to comply with stringent cGMP standards, facilitating the approval process for finished formulations. Chinese and Indian suppliers have expanded their global footprint by achieving these certifications, making them competitive globally.

Emerging Suppliers and Market Dynamics

Emerging suppliers in Southeast Asia, Eastern Europe, and Africa are beginning to penetrate the market, driven by lower manufacturing costs and increasing demand for affordable generic drugs. Notably, the ongoing geopolitical and trade considerations, such as US-China relations and Indian trade policies, influence supplier decisions and market stability.

Supply Chain Challenges and Opportunities

Quality assurance and regulatory compliance remain barriers for some emerging suppliers. Only those with validated manufacturing processes and cGMP certification can reliably supply to regulated markets.
Supply security concerns are heightened by global disruptions, including COVID-19 impact on manufacturing sites, logistics, and raw material availability.
Pricing pressures from generics manufacturers are encouraging vertical integration and localized manufacturing to control costs.
Innovation and patent expirations: The loss of patent protections in key markets has facilitated the entry of multiple generic suppliers, expanding the supplier base but intensifying competition.

Strategic Implications for Stakeholders

Pharmaceutical companies should cultivate relationships with multiple API and finished dosage form suppliers, ensuring diversified sourcing to mitigate risks.
Regulatory diligence is essential when selecting suppliers, particularly regarding cGMP compliance and international certifications.
Monitoring geopolitical and trade policies aids in anticipating supply chain shifts, especially for Chinese and Indian suppliers.
Evaluating suppliers on their scalability, cost structure, and quality track record informs inventory planning and cost management.

Conclusion

The supply of megestrol acetate is characterized by a diversified array of reputable domestic and international manufacturers. China and India dominate API production due to cost advantages and capacity, while established pharmaceutical firms and generic producers serve regional and global markets. Ensuring consistent, high-quality supply necessitates engaging with suppliers demonstrating rigorous quality standards and strategic flexibility amid geopolitical and market fluctuations.

Key Takeaways

Diversify sourcing by engaging multiple suppliers across different regions to mitigate risks.
Prioritize suppliers with cGMP certification and regulatory approval to ensure compliance in regulated markets.
Monitor geopolitical tensions and trade policies that could influence supply chain stability, especially regarding China and India.
Leverage emerging markets as cost-effective sources, balancing quality and supply security through due diligence.
Continuously evaluate the capacity and reliability of suppliers to adapt to evolving market demands and regulatory landscapes.

FAQs

1. Who are the leading global manufacturers of megestrol acetate API?
Chinese pharmaceutical companies like Hunan Xiangzhong Pharmaceutical and Guangzhou Hangson Pharmaceutical dominate API production, complemented by Indian firms such as Hetero Labs and Aurobindo Pharma, and by established Western companies like Pfizer.

2. Are there regulatory challenges associated with sourcing megestrol acetate from emerging suppliers?
Yes. Suppliers in regions like China and India must obtain and maintain international standards such as cGMP certification. Verification of regulatory compliance is critical when sourcing APIs and finished formulations for use in regulated markets.

3. How does patent status influence the supply chain of megestrol acetate?
Patent expirations for megestrol acetate have facilitated the entry of numerous generic manufacturers, expanding the supplier base and increasing competition, which can impact pricing and supply stability.

4. What are some risks associated with the global supply of megestrol acetate?
Risks include geopolitical tensions, supply chain disruptions due to COVID-19 or natural disasters, quality issues, and regulatory delays or non-compliance.

5. How can pharmaceutical companies ensure a secure supply of megestrol acetate?
By diversifying supplier networks, conducting rigorous supplier audits, maintaining regulatory compliance, and establishing strategic inventory reserves to buffer against supply disruptions.

Sources

[1] "Megestrol Acetate API Market Analysis," PharmaChem Reports, 2022.
[2] "Global API Manufacturing Landscape," International Pharmaceutical Industry Review, 2021.
[3] "Regulatory Standards for API Suppliers," U.S. FDA and EMA Guidance Documents, 2022.
[4] "Chinese Pharmaceutical Industry Outlook," China Pharmaceutical Economic Review, 2022.
[5] "Indian Pharmaceutical Market & API Manufacturers," Indian Brand Equity Foundation, 2023.

Suppliers and packagers for generic pharmaceutical drug: MEGESTROL ACETATE