Suppliers and packagers for avodart

avodart

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Waylis Therap	AVODART	dutasteride	CAPSULE;ORAL	021319	NDA	Waylis Therapeutics LLC	80725-712-04	90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-04)	2022-12-15
Waylis Therap	AVODART	dutasteride	CAPSULE;ORAL	021319	NDA	Waylis Therapeutics LLC	80725-712-15	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-15)	2022-12-15

Last updated: August 2, 2025

ppliers for the Pharmaceutical Drug: AVODART

Introduction
Avodart (dutasteride) is a prescription medication primarily used to treat benign prostatic hyperplasia (BPH) and to mitigate the risk of prostate cancer. It functions as a 5-alpha-reductase inhibitor, reducing dihydrotestosterone levels, which contributes to prostate size reduction (1). The global supply chain for Avodart involves a complex network of primary manufacturers, component suppliers, and distribution entities. Understanding these suppliers is crucial for healthcare providers, pharmaceutical companies, and market analysts aiming to gauge supply security, pricing trends, and regulatory compliance.

---

Manufacturers of Dutasteride

The active pharmaceutical ingredient (API) in Avodart, dutasteride, is synthesized primarily by a select group of specialized chemical manufacturers. These companies supply the raw material to the original drug developer, GlaxoSmithKline (GSK), or other generic pharmaceutical firms seeking to produce equivalent formulations (2).

GSK – The Original Developer
GlaxoSmithKline developed Avodart, gaining approval in multiple markets. GSK is both the manufacturer of the finished dosage form and a key supplier of the API, sourcing dutasteride from its own facilities or via contracted manufacturers. GSK’s global manufacturing centers, notably in Ireland, the UK, and the US, maintain high standards of Good Manufacturing Practice (GMP) compliance (3).

Contract Manufacturing Organizations (CMOs)
GSK and other pharmaceutical companies often outsource API production to specialized CMOs to meet production demands, optimize costs, or navigate regulatory requirements. Prominent CMOs involved in dutasteride synthesis include:

• Sun Pharmaceutical Industries
  An Indian drug manufacturer with a broad API portfolio, capable of producing dutasteride at scale (4).

• Hetero Drugs
  Another Indian company with extensive capabilities in steroid and hormonal API synthesis, including 5-alpha-reductase inhibitors (5).

• Mitsubishi Chemical Corporation
  A Japanese chemical manufacturing firm involved in complex pharmaceutical intermediate synthesis, possibly serving Asian markets or as a supplier for downstream formulations (6).

Market Dynamics and API Sourcing
Most of the global supply of dutasteride comes from Indian and Chinese API manufacturers due to cost efficiencies and established chemical manufacturing infrastructure (7). These companies often produce under strict GMP standards to meet international regulatory requirements, including U.S. FDA and EMA compliance.

---

Finished Dosage Form Suppliers

While GSK originally manufactured Avodart, generic formulations are now widely available globally. Generics companies procure API from the above-listed suppliers or other certified manufacturers. Leading generic manufacturers include:

• Teva Pharmaceutical Industries
  A global leader in generic medicines, Teva sources dutasteride APIs from multiple suppliers and markets generic versions primarily in the US and Europe (8).

• Mylan (now part of Viatris)
  Known for their extensive generic portfolio, Mylan’s sourcing of dutasteride is similar, relying on competitive API suppliers to meet demand (9).

• Sun Pharmaceutical
  Beyond API manufacturing, Sun Pharmaceutical produces finished formulations, distributing Avodart and its generics across Asia and other regions (10).

• Sandoz (a Novartis division)
  Supplies both API and finished products, leveraging a global supply chain for competitive pricing and quality assurance (11).

Regional and Regulatory Factors
The emergence of regional suppliers in India, China, and Latin America reflects a shift towards cost-effective sourcing. Regulatory bodies like the FDA and EMA enforce strict GMP standards, ensuring API quality regardless of geographic origin, though supply chain risks remain during geopolitical tensions or logistical disruptions (12).

---

Supply Chain Challenges and Risks

• Regulatory Compliance: API suppliers must adhere to strict GMP standards. Non-compliance can lead to supply disruptions or product recalls (13).
• Manufacturing Capacity: Limited production capacity at the API level can constrain supply, especially amid rising global demand or manufacturing disruptions (14).
• Raw Material Availability: The synthesis of dutasteride relies on complex chemical intermediates; shortages of raw chemicals can impact production timelines.
• Geopolitical and Trade Tensions: Tariffs, export restrictions, or geopolitical conflicts in key manufacturing regions (India, China) pose risks (15).
• Quality Variability: Ensuring consistent API quality across multiple suppliers remains a challenge, impacting market stability (16).

---

Market Trends and Implications

The global market for dutasteride and Avodart is consolidating, with major players focusing on securing high-quality API sources and expanding manufacturing capacity. The rise of generic alternatives has increased competition, leading to price declines and wider accessibility. Moreover, regulatory scrutiny and supply chain resilience are becoming critical strategic considerations for pharmaceutical companies involved in Avodart’s manufacturing and distribution.

Strategic Recommendations for Stakeholders

• Pharmaceutical companies should diversify API sourcing to mitigate risks.
• Regular supplier audits and rigorous quality checks ensure compliance and consistent supply.
• Monitoring geopolitical developments helps anticipate supply disruptions.
• Investment in advanced manufacturing technology can enhance capacity and quality control.

---

Key Takeaways

• Main API Suppliers: Indian and Chinese API manufacturers, including Sun Pharma, Hetero, and others, supply dutasteride to original and generic makers.
• Original Manufacturer: GSK produces Avodart and sources API through contracted CMOs.
• Global Supply Chain: The market relies heavily on cost-effective API production in Asia, with stringent quality controls aligning with international standards.
• Risks and Challenges: Regulatory compliance, capacity limitations, raw material shortages, and geopolitical tensions pose ongoing supply risks.
• Market Outlook: Continued consolidation, increased generic competition, and focus on supply chain resilience are shaping the future of Avodart’s supply landscape.

---

FAQs

1. Who are the primary manufacturers of dutasteride API for Avodart?
   The primary API manufacturers include Sun Pharmaceutical Industries, Hetero Drugs, and Mitsubishi Chemical Corporation, with GSK sourcing from these or similar entities.

2. Can generic manufacturers produce Avodart with the same quality as the original?
   Yes. Generic manufacturers sourcing API from GMP-compliant suppliers can produce bioequivalent and high-quality versions of Avodart, provided rigorous quality assurance processes are followed.

3. What factors influence the cost of dutasteride API?
   Manufacturing complexity, raw material availability, scale of production, regulatory compliance costs, and geopolitical stability all influence API pricing.

4. Are there risks in sourcing dutasteride API from Asian manufacturers?
   Potential risks include regulatory non-compliance, quality variability, geopolitical tensions, and supply disruptions, but adherence to GMP standards can mitigate these concerns.

5. How might supply chain disruptions affect Avodart availability?
   Disruptions at the API level or in logistics can lead to shortages of finished Avodart, impacting treatment availability and pricing. Diversification of suppliers and inventory planning are essential mitigation strategies.

---

References

1. European Medicines Agency. Avodart (dutasteride) Summary of Product Characteristics.
2. U.S. Food and Drug Administration. Drug Establishments Inventory.
3. GlaxoSmithKline Annual Reports.
4. Sun Pharmaceutical Industries Ltd. API Portfolio.
5. Hetero Drugs Ltd. Product Catalog.
6. Mitsubishi Chemical Corporation. Pharmaceutical Intermediates.
7. IQVIA. Global API Market Report 2022.
8. Teva Pharmaceutical Industries Ltd. Product Information.
9. Viatris (formerly Mylan). Market Data Sheet.
10. Sun Pharmaceutical Industries Ltd. Finished Products.
11. Sandoz (Novartis). API and Finished Goods Portfolio.
12. WHO. Good Manufacturing Practices (GMP) Guidelines.
13. FDA Enforcement Reports.
14. MarketWatch. API Capacity Trends, 2022.
15. The Economist. Global Trade and Supply Chain Risks, 2023.
16. PharmTech. Ensuring API Quality Consistency.