Suppliers and packagers for AROMASIN

AROMASIN

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	AROMASIN	exemestane	TABLET;ORAL	020753	NDA	Pharmacia & Upjohn Company LLC	0009-7663-04	30 TABLET in 1 BOTTLE (0009-7663-04)	1999-10-21
Pfizer	AROMASIN	exemestane	TABLET;ORAL	020753	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-2858-1	30 TABLET, SUGAR COATED in 1 BOTTLE (59762-2858-1)	2011-04-01

Suppliers for the Pharmaceutical Drug: Aromasin (Exemestane)

Last updated: August 7, 2025

Introduction

Aromasin, with the generic name exemestane, is a third-generation aromatase inhibitor primarily prescribed for hormone receptor-positive breast cancer in postmenopausal women. Developed and marketed by pharmaceutical company Pfizer, Aromasin offers significant therapeutic benefits when used under proper medical supervision. As demand for Aromasin grows, numerous suppliers in the pharmaceutical supply chain, including manufacturers, exporters, and distributors, have entered the market, both within and outside regulatory jurisdictions. This article provides a comprehensive overview of Aromasin suppliers, emphasizing their roles, regional presence, and industry impact.

Overview of Aromasin (Exemestane)

Aromasin functions by irreversibly inhibiting aromatase enzyme activity, thus reducing estrogen synthesis—a critical pathway in estrogen-dependent breast cancers. Since its FDA approval in 1999 and subsequent approval in many other markets, Aromasin has become a vital component of breast cancer treatment protocols. Its patent expiry has facilitated global manufacturing and distribution, leading to a diverse supplier network.

Key Manufacturers of Aromasin

Pfizer: The Original Manufacturer

Pfizer holds the patent for Aromasin and remains the primary producer of branded Exemestane. The company operates manufacturing facilities in the US and Europe, adhering to stringent Good Manufacturing Practices (GMP). Pfizer's extensive global distribution network ensures reliable supply chains for Aromasin.

Generic Manufacturers

Post-patent expiration, numerous pharmaceutical companies have begun producing generic versions of exemestane, increasing market competition and accessibility. Notable generic manufacturers include:

• Hetero Drugs Ltd. (India): A leading producer with WHO-GMP certification, Hetero supplies high-quality generic exemestane to numerous markets worldwide.
• Cipla Limited (India): Known for its robust API manufacturing, Cipla produces affordable exemestane formulations that meet international standards.
• Granules India (India): Focused on high-volume production, offering cost-effective exemestane APIs and finished medicines.
• Sun Pharmaceutical Industries (India): A global generic drug producer manufacturing exemestane APIs compliant with regulatory standards.
• Mylan (USA): Although primarily known for generics in the US, Mylan has supplied exemestane APIs and formulations to various markets.

Manufacturing Hubs

Most exemestane APIs and finished products are manufactured in pharmaceutical hubs like India, China, and Eastern Europe. These regions host multiple WHO-GMP and FDA-approved facilities, boosting the global supply chain's robustness.

Major Exporters and Distributors

India

India is a predominant exporter of exemestane, with major pharmaceutical companies milling APIs and finished medicines for global markets. The Indian government and industry bodies like the Indian Drug Manufacturers' Association (IDMA) actively promote export capabilities.

China

China’s pharmaceutical industry supplies raw excipients and active pharmaceutical ingredients (APIs), including exemestane, often for conversion or formulation elsewhere. Although local production is strong, regulatory compliance varies across manufacturers.

Eastern Europe

Countries such as Hungary and Poland host established manufacturing and distribution companies offering compliant exemestane products for European markets.

Middle East & Africa

Regional distributors engage in importing and distributing both branded and generic exemestane, often serving as intermediaries in the supply chain.

Global Supply Chain Dynamics

The supply chain for Aromasin involves multiple tiers, including API producers, formulation facilities, and distribution channels affected by regulatory standards, quality assurance measures, and geopolitical factors. Regulatory approvals from authorities like the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO) influence the entry and operations of suppliers.

Quality and Regulatory Compliance

Ensuring high-quality APIs and finished formulations is crucial in oncology medicines. Suppliers must adhere to GMP and obtain certifications from relevant authorities, which significantly influence market trust and acceptance. Major suppliers typically provide:

• WHO-GMP certification
• FDA approval for US markets
• EMA approval for European markets
• ISO certifications

Quality assurance remains paramount, given the life-saving nature of Aromasin.

Market Trends and Future Outlook

The rise of biosimilars and enhanced manufacturing capacity suggest increased availability of Aromasin alternatives. Nonetheless, existing suppliers continue to capitalize on patents, regional regulations, and quality standards to sustain their market share. The ongoing demand, driven by breast cancer prevalence, steady obstructs supply chain challenges like regulatory hurdles, raw material shortages, and geopolitical disruptions.

Key Players Summary

Supplier Type	Notable Companies	Regional Focus	Certifications
Original Manufacturer	Pfizer	Global (US/EU)	FDA, EMA, WHO-GMP
Generic API Manufacturers	Hetero Drugs, Cipla, Granules India	India	WHO-GMP, ISO, USFDA
Distributors	Local and regional pharma distributors	Asia, Europe, Middle East	Vary by region

Conclusion

The Aromasin supply chain is characterized by a blend of original patent holders and a wide array of generic manufacturers and distributors, predominantly located in India and China. The ongoing global demand and regulatory standards necessitate high-quality production and compliance, underpinning supplier credibility. Companies seeking reliable Aromasin suppliers should prioritize certifications, manufacturing standards, and regional regulatory landscapes to ensure product integrity and timely delivery.

Key Takeaways

• Pfizer remains the primary producer of branded Aromasin, with robust global distribution.
• The generic market has expanded significantly, mainly led by Indian pharmaceutical firms like Hetero, Cipla, and Granules India.
• Regulatory compliance (GMP, FDA, EMA) is critical for supplier credibility and market acceptance.
• Regional hubs such as India and China dominate API and finished-product manufacturing, driven by cost advantages and capacity.
• Market stability depends on maintaining quality standards amid geopolitical and logistical challenges.

FAQs

1. Are generic exemestane products as effective as branded Aromasin?
Yes. Generic exemestane produced by WHO-GMP certified manufacturers contains the same active ingredients and meets bioequivalence standards, ensuring similar efficacy when prescribed correctly.

2. How can I verify the authenticity of exemestane suppliers?
Check for certifications such as WHO-GMP, FDA approval, and ISO standards. Confirm supplier reputation through industry references, and request batch testing reports and Certificates of Analysis (CoA).

3. What regions are most reliable for sourcing Aromasin?
India and the USA are major sources due to established regulatory standards and manufacturing expertise. European suppliers also maintain high-quality practices, especially for exports to regulated markets.

4. Will patents affect the availability of Aromasin?
Pfizer's patent expired in various markets, allowing generic manufacturers to produce exemestane. However, in regions where patents are still active, access may be limited to branded products licensed or approved through ongoing patent protections.

5. What challenges face Aromasin supply chains?
Key challenges include raw material shortages, regulatory compliance hurdles, geopolitical issues impacting trade, and manufacturing capacity constraints, especially during global crises like COVID-19.

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Sources

1. Pfizer official website. Aromasin (exemestane) product information.
2. World Health Organization. WHO-GMP Certification Database.
3. Indian Drug Manufacturers' Association (IDMA). Industry reports on generic pharmaceutical production.
4. U.S. Food & Drug Administration. Approved drug products with therapeutic equivalence evaluations.
5. Market analysis reports on the global pharmaceutical active ingredients supply chain.