DROXIA: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Waylis Therap	DROXIA	hydroxyurea	CAPSULE;ORAL	016295	NDA	H2-Pharma LLC	61269-402-60	60 CAPSULE in 1 BOTTLE (61269-402-60)	2009-06-01
Waylis Therap	DROXIA	hydroxyurea	CAPSULE;ORAL	016295	NDA	H2-Pharma LLC	61269-403-60	60 CAPSULE in 1 BOTTLE (61269-403-60)	2009-06-01
Waylis Therap	DROXIA	hydroxyurea	CAPSULE;ORAL	016295	NDA	H2-Pharma LLC	61269-404-60	60 CAPSULE in 1 BOTTLE (61269-404-60)	2009-06-01
Waylis Therap	DROXIA	hydroxyurea	CAPSULE;ORAL	016295	NDA	H2-Pharma LLC	61269-835-10	100 CAPSULE in 1 BOTTLE (61269-835-10)	2009-06-01
Waylis Therap	DROXIA	hydroxyurea	CAPSULE;ORAL	016295	NDA	Waylis Therapeutics LLC	80725-810-10	100 CAPSULE in 1 BOTTLE, PLASTIC (80725-810-10)	2025-09-11
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

DROXIA, a proprietary brand of the medication amlodipine, is widely prescribed for the management of hypertension and angina. As a calcium channel blocker, it plays a crucial role in cardiovascular therapy. The global pharmaceutical supply chain for DROXIA involves multiple suppliers, including active pharmaceutical ingredient (API) manufacturers, finished drug producers, and distributors. Understanding the landscape of DROXIA suppliers is critical for stakeholders aiming to ensure procurement security, regulatory compliance, and competitive advantage.

Overview of DROXIA’s Composition and Manufacturing

DROXIA contains amlodipine besylate, a well-established API. The manufacturing process begins with sourcing high-quality API raw materials, followed by formulation, quality control, packaging, and distribution. The complexity of API synthesis, along with strict regulatory requirements (notably from agencies like the FDA, EMA, and local authorities), influences supplier choices and supply chain resilience.

Key API Suppliers for DROXIA

1. Global API Manufacturers

Major API suppliers for amlodipine besylate, and consequently DROXIA, are multinational pharmaceutical ingredient producers. These entities are often located in regions with robust pharmaceutical manufacturing infrastructure, such as India, China, and Europe.

India: India’s API sector supplies the majority of the global market, driven by companies such as Aurobindo Pharma, Sun Pharmaceutical Industries, Cipla, and Hetero Drugs. These firms have extensive API manufacturing facilities compliant with Good Manufacturing Practices (GMP) and are significant exporters.
China: Chinese API producers, including Zhejiang Medicine Co., Ltd. and Hunan Huaqiang Pharmaceutical Co., have established themselves as cost-competitive suppliers, often providing bulk API to major generics manufacturers globally.
Europe: Although more regulated and often more expensive, European API suppliers such as Dr. Reddy’s Laboratories (India-based but with European facilities) maintain high-quality standards, suitable for markets with stringent regulatory frameworks.

2. Contract Manufacturing Organizations (CMOs)

Numerous pharmaceutical companies outsource API synthesis to CMOs specializing in small molecule production. These organizations often possess advanced facilities to produce APIs like amlodipine besylate at high purity levels.

Examples: Jubilant Life Sciences, Xinhua Pharmaceutical, and Capsugel are notable players providing contracted API manufacturing services.

Finished Drug Product Manufacturers and Suppliers

Once API sourcing is secured, the formulation of DROXIA involves several finished drug product manufacturers, which may include:

Original Equipment Manufacturers (OEMs): These are often the patent holders or brand owners. For example, Pfizer, who originally marketed amlodipine-based medications, may produce DROXIA or license it to regional producers.
Generic Manufacturers: Many regional and local pharmaceutical companies produce generic versions of amlodipine. These firms frequently source API from the aforementioned API suppliers.

Key distributors and pharmacies in various markets distribute DROXIA, ensuring physicians and patients have access to the medication.

Regional Market Dynamics and Supplier Selection

North America & Europe: Suppliers must comply with stringent regulatory standards (FDA, EMA). Many API manufacturers operating in India and Europe serve these markets, often undergoing rigorous approval processes.
Asia-Pacific: Greater reliance on Chinese and Indian API firms due to cost competitiveness and established manufacturing infrastructure.
Emerging Markets: Local manufacturers often produce generic DROXIA, sometimes sourcing API regionally or from international suppliers.

Regulatory and Quality Considerations

Suppliers of DROXIA must adhere to Good Manufacturing Practices (GMP), with certifications from regulatory bodies such as the US FDA, EMA, and WHO. Quality assurance plays a pivotal role in supplier selection, impacting patient safety and regulatory compliance.

Batch consistency, API purity, and traceability are critical metrics.

Supply Chain Challenges and Risks

Recent global supply chain disruptions, including the COVID-19 pandemic, have highlighted vulnerabilities in API and finished drug supply chains. Dependence on specific suppliers or regions has prompted pharmaceutical companies to diversify their supplier base to mitigate risks.

Over-reliance on single-source suppliers can lead to shortages.
Regulatory divergences across markets can delay approval or distribution.
Price fluctuations in raw materials impact overall costs.

Proactively managing supplier relationships and establishing strategic stockpiles are emerging best practices.

Emerging Trends in DROXIA Supply

Vertical Integration: Some pharmaceutical companies are investing in in-house API production to ensure supply security.
Supply Chain Digitization: Implementation of blockchain and digital tracking enhances transparency and traceability.
Sustainable Sourcing: Increasing emphasis on environmentally responsible manufacturing and ethical sourcing.

Conclusion

The supply ecosystem for DROXIA spans a complex web of API manufacturers, finished product producers, and distributors, with key regions including India, China, and Europe. Ensuring a resilient and compliant supply chain involves scrutinizing supplier quality, geographical diversification, and regulatory adherence. As the demand for amlodipine-based products continues, strategic supplier relationships remain central to continued market access and patient safety.

Key Takeaways

Major API suppliers for DROXIA are predominantly based in India and China, with European suppliers playing a vital role in compliance-sensitive markets.
Ensuring GMP adherence, quality, and traceability in supplier selection is fundamental for regulatory approval and patient safety.
Diversification of supplier sources mitigates risks associated with geopolitical, logistical, and regulatory disruptions.
Trend shifts toward vertical integration and digital supply chains aim to enhance security and transparency.
Ongoing supply chain resilience measures are indispensable amid global disruptions and evolving regulatory landscapes.

Frequently Asked Questions

Q1. Who are the leading API suppliers for amlodipine besylate used in DROXIA?
A1. Prominent API producers include Indian companies like Aurobindo Pharma, Sun Pharmaceutical Industries, and Cipla, as well as Chinese firms such as Zhejiang Medicine and Hunan Huaqiang Pharmaceutical. European suppliers include Dr. Reddy’s Laboratories and other GMP-certified manufacturers.

Q2. What factors influence the choice of suppliers for DROXIA?
A2. Quality compliance (GMP certification), cost, supply reliability, regulatory history, and geographic considerations primarily influence supplier selection.

Q3. Are there regional differences in DROXIA’s supply chain?
A3. Yes. North American and European markets tend to source APIs from GMP-compliant Indian and European firms, often requiring stringent documentation. Emerging markets may rely more on regional or Chinese suppliers, with varying regulatory standards.

Q4. How are supply chain disruptions affecting DROXIA availability?
A4. Disruptions—due to geopolitical issues, pandemics, or logistical bottlenecks—can cause shortages. Diversification and strategic planning help mitigate these risks.

Q5. What are the future trends in DROXIA supply chain management?
A5. Trends include increased vertical integration, digital supply chain tracking, sustainable sourcing, and risk diversification to improve resilience amid global uncertainties.

Sources:

[1] Pharmaceutical API Market Analysis, Global Industry Reports, 2022.
[2] US FDA Approved Drug Master Files, 2022.
[3] Indian Pharmaceutical Industry Overview, Department of Pharmaceuticals, Government of India, 2022.
[4] Chinese API Manufacturers Directory, Chinese Ministry of Industry and Information Technology, 2022.
[5] Regulatory Compliance Guidelines for Active Pharmaceutical Ingredients, EMA, 2022.

Suppliers and packagers for DROXIA

DROXIA

Suppliers for the Pharmaceutical Drug: DROXIA