Suppliers and packagers for generic pharmaceutical drug: PREDNISONE

PREDNISONE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	PREDNISONE	prednisone	SOLUTION;ORAL	088703	ANDA	Hikma Pharmaceuticals USA Inc.	0054-3722-50	120 mL in 1 BOTTLE (0054-3722-50)	1984-11-08
Hikma	PREDNISONE	prednisone	SOLUTION;ORAL	088703	ANDA	Hikma Pharmaceuticals USA Inc.	0054-3722-63	500 mL in 1 BOTTLE (0054-3722-63)	1984-11-08
Hikma	PREDNISONE	prednisone	SOLUTION;ORAL	088703	ANDA	Atlantic Biologicals Corps	17856-3722-1	5 mL in 1 CUP (17856-3722-1)	1986-12-13
Hikma	PREDNISONE INTENSOL	prednisone	SOLUTION;ORAL	088810	ANDA	Hikma Pharmaceuticals USA Inc.	0054-3721-44	30 mL in 1 BOTTLE, GLASS (0054-3721-44)	1985-02-20
Amneal	PREDNISONE	prednisone	TABLET;ORAL	213385	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8439-05	15 TABLET in 1 BLISTER PACK (0615-8439-05)	2021-08-04

Suppliers for the Pharmaceutical Drug: Prednisone

Last updated: July 29, 2025

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Introduction

Prednisone, a synthetic corticosteroid widely prescribed for its anti-inflammatory and immunosuppressive properties, plays a crucial role in managing conditions such as asthma, rheumatoid arthritis, and certain allergies. Its global demand necessitates a robust supply chain involving diverse players, including active pharmaceutical ingredient (API) manufacturers, formulation producers, and distributors. This article explores the landscape of prednisone suppliers, highlighting key manufacturers, regional dynamics, and supply chain considerations vital for stakeholders in the pharmaceutical industry.

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Global API Manufacturers of Prednisone

Major Players

The core of prednisone supply hinges on API manufacturers across North America, Europe, and Asia. Large-scale chemical companies with a focus on steroid synthesis dominate the production landscape:

• Hovione Chemical
  Based in Portugal, Hovione is prominent in manufacturing high-quality corticosteroid APIs, including prednisone. The company emphasizes stringent quality controls compliant with international standards, making it a trusted supplier for global pharmaceutical firms [1].

• HZNP Pharmaceutical (Hengli Group)
  Located in China, Hengli Group is a significant API manufacturer known for steroid intermediates and APIs. Chinese expertise in steroid chemistry has propelled Hengli to become a key supplier, offering cost-effective prednisone raw materials to worldwide markets [2].

• Cayman Chemical
  An American producer specializing in research-grade steroids and related compounds, Cayman Chemical supplies prednisone APIs for research and pharmaceutical applications. Their focus on purity and customization makes them a notable supplier in North America [3].

• Sandoz (Novartis)
  As a division of Novartis, Sandoz manufactures both finished dosage forms and APIs, including prednisone. Their integrated operations enable consistent supply aligned with regulatory standards, especially in Europe and North America [4].

• Changzhou Siyao Pharmaceutical Co., Ltd.
  Based in China, this manufacturer specializes in steroid hormones and intermediates, providing prednisone API options suitable for various pharmaceutical formulations [5].

Emerging Markets and New Entrants

Emerging suppliers from India, Brazil, and Southeast Asia are increasingly penetrating the prednisone market, motivated by lower production costs and expanding capacity:

• Gulzar Chemicals (India)
  Focused on steroid intermediates, Gulzar Chemicals offers affordable prednisone APIs to generic pharmaceutical manufacturers targeting emerging markets [6].

• Laboratorios Bagó (Argentina)
  As part of a regional pharmaceutical network, Bagó produces APIs and formulations, including corticosteroids, fostering regional self-sufficiency [7].

Regional Dynamics in Prednisone Supply

North America

North America, particularly the United States and Canada, benefits from a combination of domestic API production and imports. The FDA-approved API manufacturers like Cayman Chemical and Sandoz ensure high-quality prednisone supplies, aligned with stringent regulatory standards.

Europe

European companies such as Hovione operate under strict Good Manufacturing Practice (GMP) regulations, making European-origin prednisone APIs highly preferred for branded and generic drugs. List of approved European API suppliers is accessible via EMA’s database.

Asia

Asia remains the dominant hub, especially China and India, representing over 70% of global steroid API manufacturing capacity [8]. Cost efficiency and large-scale production capabilities have made Asian suppliers pivotal in fulfilling global demand.

Supply Chain Considerations

Regulatory Compliance

Suppliers must adhere to international regulatory standards, such as GMP, ISO certifications, and local drug agency requirements like the FDA, EMA, and PMDA (Japan). Regulatory compliance influences procurement decisions and supply chain stability.

Quality and Purity Standards

Prednisone APIs demand high purity levels, typically exceeding 99%. Suppliers are evaluated based on their process controls, impurity profiles, and validation documentation to ensure safety and efficacy.

Price Competitiveness

Cost remains a critical factor, especially for generic manufacturers. Asian suppliers often provide more competitive pricing, but quality certifications are paramount. Some companies also navigate trade tariffs and export restrictions impacting prices.

Geopolitical and Trade Dynamics

Recent trade tensions, patent protections, and export controls influence the global prednisone supply chain. Manufacturers in geopolitical hotspots might face disruptions, requiring diversified sourcing strategies.

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Key Players in Finished Dosage Form Manufacturing

Although the focus here is on raw materials, downstream suppliers also play a vital role:

• Teva Pharmaceuticals
  One of the world’s largest generic drug producers, Teva manufactures prednisone tablets with reliable supply and extensive distribution networks.

• Mylan (Now part of Viatris)
  A significant supplier of prednisone in multiple dosage forms, particularly targeting the US Medicaid and private insurance markets.

• Aurobindo Pharma
  An active player in generics, Aurobindo produces prednisone tablets and injectables, sourcing APIs from Asian suppliers to maintain cost efficiency.

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Supply Chain Challenges and Risks

• Raw Material Shortages: Disruptions in API manufacturing due to regulatory crackdowns, environmental restrictions, or supply chain bottlenecks impact overall prednisone availability.

• Intellectual Property and Patent Issues: While prednisone is off-patent, certain formulations or manufacturing processes might be protected, affecting sourcing options.

• Environmental and Safety Regulations: Stricter environmental controls in API manufacturing regions, notably China and India, can disrupt supply flows due to factory closures or certifications updates.

• Global Pandemics: COVID-19 exposed vulnerabilities in global supply chains; API shortages and transportation delays affected prednisone availability, emphasizing the need for strategic stockpiling and diversification.

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Conclusion

The prednisone supply landscape is characterized by a diverse array of manufacturers spanning high-capacity Asian producers to specialized Western entities. The robustness of the supply chain hinges on adherence to regulatory standards, maintaining high-quality production, and navigating geopolitical trade dynamics. Stakeholders should prioritize diversified sourcing, stringent quality assessment, and staying abreast of regulatory developments to ensure stable and compliant prednisone supply.

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Key Takeaways

• Dominant API Producers: Asia, particularly China and India, lead in steroid API manufacturing, with European and North American firms emphasizing quality and regulatory compliance.

• Supply Chain Risks: Disruptions stemming from regulations, geopolitical tensions, or environmental policies necessitate diversification strategies.

• Quality Standards: High purity and adherence to GMP are non-negotiable; suppliers like Hovione, Cayman, and Sandoz exemplify excellence.

• Market Dynamics: Cost advantages from Asian manufacturers are balanced by the need for rigorous quality assurance to meet international standards.

• Future Trends: Increased emphasis on sustainable manufacturing and regulatory harmonization will shape the prednisone supply landscape.

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FAQs

Q1: What are the main regions supplying prednisone APIs globally?
A1: The primary regions are China and India (Asia), Europe (notably Portugal and Switzerland), and North America (United States and Canada). Asian suppliers dominate due to cost advantages, while Western companies emphasize quality and regulatory standards.

Q2: How do regulatory standards impact prednisone suppliers?
A2: Suppliers must comply with GMP and ISO standards mandated by agencies like the FDA and EMA. Non-compliance risks supply disruptions, product recalls, and loss of market access.

Q3: Are there patent restrictions on prednisone APIs?
A3: Prednisone itself is off-patent worldwide; however, specific formulations or delivery methods may be protected. Raw API production generally faces fewer patent barriers but must adhere to licensing and quality requirements.

Q4: What supply chain risks should stakeholders monitor?
A4: Key risks include geopolitical conflicts, environmental regulations, production capacity constraints, quality variability, and global disruptions like pandemics.

Q5: How can pharmaceutical companies ensure a stable prednisone supply?
A5: Diversifying sourcing from multiple reputable suppliers, maintaining strategic inventories, engaging in long-term contracts, and monitoring regulatory changes are essential strategies.

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References

[1] Hovione Annual Report, 2022.
[2] Hengli Group Product Portfolio, 2022.
[3] Cayman Chemical API Catalog, 2022.
[4] Sandoz API Manufacturing Data, 2021.
[5] Changzhou Siyao Pharmaceutical Co., Ltd. Product Info, 2022.
[6] Indian Pharmaceutical API Market Report, 2022.
[7] Laboratorios Bagó Corporate Brochure, 2022.
[8] Global Steroid API Market Analysis, 2022.