Suppliers and packagers for DURACLON

DURACLON

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Institutional	DURACLON	clonidine hydrochloride	INJECTABLE;INJECTION	020615	NDA	Mylan Institutional LLC	67457-218-10	1 VIAL in 1 CARTON (67457-218-10) / 10 mL in 1 VIAL	1997-01-26

Suppliers for the Pharmaceutical Drug: Duraclon

Last updated: July 29, 2025

Introduction
Duraclon, a pharmaceutical formulation containing clonidine hydrochloride, is primarily utilized as an epidural analgesic and antihypertensive agent. Its applications extend to managing severe hypertension and chronic pain, particularly in anesthetic settings. As with many specialized drugs, sourcing reliable suppliers is critical to ensuring product quality, regulatory compliance, and supply chain continuity. This analysis explores the landscape of Duraclon suppliers, including manufacturing entities, authorized distributors, and considerations for procurement professionals.

Overview of Duraclon and Its Composition
Duraclon’s active pharmaceutical ingredient (API) is clonidine hydrochloride, a centrally acting alpha-2 adrenergic agonist. It’s crucial to distinguish between primary manufacturers of the API and those involved in the finished drug product. The drug’s formulation is sensitive, demanding high manufacturing standards adhering to Good Manufacturing Practices (GMP).

Manufacturers of Clonidine Hydrochloride API
The foundation of Duraclon supply begins with the API manufacturers. Several pharmaceutical companies globally produce high-quality clonidine hydrochloride, supplying both branded and generic markets:

1. Lupin Limited (India)
   Lupin is a leading Indian pharmaceutical firm with extensive API manufacturing capabilities, including clonidine hydrochloride. Their API is certified for global markets, including the US, Europe, and Asia. Lupin leverages GMP standards, making its clonidine suitable for formulation into branded drugs like Duraclon.

2. Sun Pharmaceutical Industries Ltd. (India)
   As one of the largest Indian pharma producers, Sun Pharma manufactures clonidine API, emphasizing high purity and consistent batch quality suited for both generic formulations and proprietary products.

3. Mylan (USA/Global)
   Mylan, now part of Viatris, produces clonidine hydrochloride APIs used in various formulations. Their adherence to stringent international quality standards makes their product a reliable source.

4. Nichi-Iko Pharmaceutical Co., Ltd. (Japan)
   Known for high-quality APIs, Nichi-Iko supplies clonidine hydrochloride primarily to the Japanese market but also exports globally, adhering to robust GMP protocols.

5. Hebei Gankem Pharmaceutical Co., Ltd. (China)
   A Chinese API manufacturer catering to domestic and international markets, Gankem emphasizes API purity and regulatory compliance for clonidine hydrochloride.

Authorized Distributors and Pharmaceutical Companies Producing Duraclon
Duraclon was historically marketed by specific pharmaceutical companies under licensing agreements. Pfizer was the original manufacturer of Duraclon (brand name for epidural clonidine), but manufacturing rights and supply status have evolved due to market dynamics and patent considerations. Currently, the following entities are involved:

1. Pfizer Inc.
   Pfizer was the original developer of Duraclon, with a focus on neurology and pain management. It was marketed widely in hospitals for epidural administration. However, Pfizer’s focus has shifted away from certain niche formulations, and supply status may vary depending on regional approvals.

2. Teva Pharmaceutical Industries Ltd.
   Teva produces generic versions of clonidine hydrochloride injectable formulations, which may be used in compounding or directly as Duraclon equivalents in certain markets.

3. Sandoz (Novartis)
   Sandoz offers generic clonidine injectable forms, often utilized by healthcare providers, though not branded explicitly as Duraclon.

4. Other Regional Manufacturers and Distributors
   Numerous regional and local pharmaceutical companies supply clonidine injectable formulations directly or through authorized distributors. These include companies in India, China, and Eastern Europe, often supplying hospitals or compounding pharmacies.

Regulatory Considerations
Procurement of Duraclon or clonidine hydrochloride APIs must prioritize regulatory compliance. Approvals must align with agencies such as the FDA (USA), EMA (Europe), and respective national health authorities. Verifying Good Manufacturing Practice (GMP) certification, batch testing, and import/export documentation is essential.

Factors Influencing Supplier Selection

• Quality Assurance: Suppliers must demonstrate compliance with GMP standards, stability data, and validated manufacturing processes.
• Regulatory Approval: Suppliers whose products are approved by relevant health authorities provide greater security for market access.
• Supply Stability: Long-term, reliable supply chains that can meet demand fluctuations are vital.
• Pricing and Logistics: Cost-effectiveness and efficient logistics impact procurement strategies.

Emerging Market Dynamics and Trends
The global generic pharmaceutical industry is increasingly competitive, with Chinese and Indian manufacturers expanding their share of API production for clonidine hydrochloride. This trend provides both opportunities for cost savings and challenges in maintaining quality standards.

Conclusion
The sourcing landscape for Duraclon and its active ingredient clonidine hydrochloride is diverse, encompassing global API producers and regional drug manufacturers. While Pfizer remains historically linked to the branded drug, current supply often involves a range of generic producers and authorized distributors who comply with international standards. Strategic procurement necessitates rigorous supplier vetting, focusing on quality, regulatory status, and supply reliability.

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Key Takeaways:

• Authentic Duraclon supply is predominantly controlled by licensed pharmaceutical companies; however, many formulations rely on APIs from major producers like Lupin, Sun Pharma, and Mylan.
• Ensuring GMP compliance and regulatory approval is essential for quality assurance and market authorization.
• The global API market for clonidine hydrochloride is competitive, with Indian, Chinese, and Japanese manufacturers leading in production.
• Procurement strategies should prioritize supplier reliability, regulatory status, and cost efficiency.
• Continuous monitoring of supplier quality performance and regulatory changes enhances supply chain resilience.

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FAQs

1. Who are the primary manufacturers of clonidine hydrochloride API used in Duraclon?
   Leading API producers include Lupin Limited, Sun Pharma, Mylan (Viatris), Nichi-Iko, and Hebei Gankem, all adhering to international GMP standards.

2. Is Duraclon still marketed, and who are the key suppliers?
   Duraclon's market presence varies by region; Pfizer originally marketed it, but current supply often involves generics from companies like Teva and Sandoz, depending on local approvals.

3. What regulatory factors should be considered when sourcing Duraclon or clonidine API?
   Suppliers must have GMP certification, product approval from relevant health authorities, and compliance with regulatory documentation for import and use.

4. Are there regional differences in Duraclon suppliers?
   Yes. Indian, Chinese, and Japanese manufacturers are prominent regional suppliers, with regional distributors providing formulations tailored to local markets.

5. How can healthcare providers ensure the quality of generic clonidine formulations?
   By sourcing from manufacturers with validated GMP compliance, recognized regulatory approvals, and proven quality track records, healthcare providers can ensure efficacy and safety.

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References:

1. [1] U.S. Food and Drug Administration. FDA Approved Drugs Database. Duraclon information.
2. [2] Pharmaceutical Market Intelligence Reports. Global clonidine hydrochloride market analysis.
3. [3] Global Pharma API Industry Trends. GMP standards and major API producers.