Suppliers and packagers for generic pharmaceutical drug: DICLOFENAC EPOLAMINE

DICLOFENAC EPOLAMINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ibsa	FLECTOR	diclofenac epolamine	SYSTEM;TOPICAL	021234	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA Inc.	0093-3727-55	6 POUCH in 1 CARTON (0093-3727-55) / 5 SYSTEM in 1 POUCH (0093-3727-50)	2020-05-01
Ibsa	FLECTOR	diclofenac epolamine	SYSTEM;TOPICAL	021234	NDA	IBSA Pharma Inc.	71858-0405-2	1 POUCH in 1 CARTON (71858-0405-2) / 2 SYSTEM in 1 POUCH (71858-0405-1)	2020-11-01
Ibsa	FLECTOR	diclofenac epolamine	SYSTEM;TOPICAL	021234	NDA	IBSA Pharma Inc.	71858-0405-5	6 POUCH in 1 CARTON (71858-0405-5) / 5 SYSTEM in 1 POUCH (71858-0405-4)	2020-11-01
Ibsa	FLECTOR	diclofenac epolamine	SYSTEM;TOPICAL	021234	NDA AUTHORIZED GENERIC	ASCLEMED USA INC.	76420-409-30	6 POUCH in 1 CARTON (76420-409-30) / 5 SYSTEM in 1 POUCH	2020-05-01

Suppliers for the Pharmaceutical Drug: Diclofenac Epolamine

Last updated: July 29, 2025

Introduction

Diclofenac epolamine is a topical nonsteroidal anti-inflammatory drug (NSAID) widely used for pain relief and inflammation reduction in soft tissue injuries. As with many pharmaceutical agents, securing reliable suppliers is critical for pharmaceutical companies, distributors, and healthcare providers to ensure consistent supply, quality, and compliance with regulatory standards. This report explores the key suppliers of diclofenac epolamine, their market positions, manufacturing capabilities, and strategic considerations for stakeholders.

Overview of Diclofenac Epolamine

Diclofenac epolamine, also known as diclofenac ammonium epolamine, exists primarily as a topical gel or patch. Its mechanism involves inhibiting cyclooxygenase (COX) enzymes, thereby decreasing prostaglandin synthesis responsible for inflammation and pain. Approved in multiple markets, the drug's formulations often include gels, patches, and topical sprays, with various brands distributed globally. The formulation's stability, bioavailability, and manufacturing quality influence supplier selection and procurement strategies.

Major Global Suppliers and Manufacturers

1. Novartis International AG

• Overview: Novartis, a global pharmaceutical leader, produces diclofenac-based products, including topical formulations containing diclofenac epolamine.
• Manufacturing Capabilities: Their R&D and manufacturing facilities are FDA- and EMA-approved, ensuring high-quality standards. Novartis supplies both branded and generic diclofenac products.
• Market Presence: Novartis's longstanding presence in pain management pharmaceuticals makes it a preferred supplier for large distributors and healthcare institutions.

2. Sandoz (Novartis Division)

• Overview: Sandoz specializes in generic pharmaceuticals, including topical NSAIDs like diclofenac epolamine.
• Manufacturing Capability: With extensive manufacturing facilities in Europe, North America, and Asia, Sandoz offers cost-effective options compliant with international quality standards (GMP).
• Market Position: As a leading generic supplier, Sandoz provides competitive pricing and reliable supply chains for diclofenac epolamine products worldwide.

3. Teva Pharmaceutical Industries Ltd.

• Overview: Teva is a major global generic and specialty pharmaceutical company.
• Product Range: Teva manufactures diclofenac epolamine topical formulations, including gels and patches, targeting North American and European markets.
• Supply Capabilities: With multiple manufacturing plants adhering to cGMP standards, Teva emphasizes quality control and supply consistency.

4. Dr. Reddy’s Laboratories

• Overview: An Indian multinational, Dr. Reddy’s offers generic diclofenac epolamine formulations, expanding accessibility in emerging markets.
• Manufacturing Facilities: Their facilities are WHO-GMP compliant, focusing on affordability without compromising quality.
• Strategic Focus: They cater to need-based markets, including South Asia, Middle East, and Latin America, often providing customized formulations.

5. Aurobindo Pharma

• Overview: Also based in India, Aurobindo manufactures various topical NSAIDs, including diclofenac epolamine gels.
• Market Reach: They serve both domestic and international markets, including North America, Africa, and Asia.
• Quality Assurance: Their manufacturing sites are FDA-approved, and they maintain stringent quality control protocols.

6. Lupin Limited

• Overview: Lupin develops and markets generic topical NSAIDs and operates manufacturing units in India and the United States.
• Product Portfolio: Their topical diclofenac formulations are known for affordability and reliable quality.
• Supply Chain: Lupin’s extensive distribution network ensures broad market availability.

7. Zhejiang Kangle Pharmaceutical Co., Ltd

• Overview: A notable Chinese pharmaceutical manufacturer specializing in topical formulations, including diclofenac epolamine.
• Market Focus: Primarily serving the Asian markets, with growing exports to other regions.
• Regulatory Compliance: Their products meet ISO standards and China Food and Drug Administration (CFDA) certifications.

Emerging Suppliers and Market Trends

The global demand for diclofenac epolamine continues to grow, driven by expanding markets in Asia, Latin America, and Africa. Several emerging manufacturers in India, China, and Eastern Europe are investing in R&D and manufacturing capacity, often offering lower-cost alternatives. However, buyers must prioritize quality assurance and regulatory compliance amid competitive pricing.

Regulatory and Quality Considerations

Suppliers must adhere to rigorous standards such as Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and certifications from regulatory authorities like the FDA, EMA, or local agencies. Traceability, bioequivalence, and batch consistency are critical metrics. Suppliers with certified quality management systems (QMS) minimize risks linked to product recalls and regulatory non-compliance.

Strategic Procurement Considerations

• Global versus Regional Suppliers: Diversifying supplier sources reduces supply chain risks, especially considering geopolitical and logistical challenges.
• Cost versus Quality Balance: While cost-effective suppliers are attractive, quality and compliance should not be compromised.
• Supply Chain Resilience: Establishing agreements with multiple suppliers ensures uninterrupted supply, especially during pandemic-related disruptions.
• Partnerships and Licensing: Collaborations with established manufacturers can facilitate regulatory approvals and market access.

Conclusion

The supply landscape for diclofenac epolamine involves a diverse array of manufacturers, ranging from established multinational corporations like Novartis, Teva, and Sandoz to emerging regional players such as Lupin and Aurobindo. While brand-name products maintain dominance in certain markets, generics play an increasingly vital role. Stakeholders must prioritize suppliers with proven compliance, robust manufacturing capabilities, and scalable logistics to meet global demand. Strategic sourcing, coupled with vigilant regulatory adherence, is vital for maintaining a steady supply and competitive advantage in the distribution of diclofenac epolamine.

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Key Takeaways

1. Leading Suppliers: Novartis, Sandoz, Teva, Dr. Reddy’s, and Aurobindo dominate the global diclofenac epolamine supply chain with high-quality manufacturing and regulatory compliance.
2. Emerging Markets: Indian and Chinese manufacturers are expanding their roles, offering cost-effective alternatives suitable for emerging markets.
3. Regulatory Dependence: Ensuring suppliers adhere to GMP and regional regulatory standards is critical for quality assurance.
4. Supply Chain Strategy: Diversify supplier sources and establish strategic partnerships to mitigate risks and ensure uninterrupted supply.
5. Market Trends: Growing demand in Asian, Latin American, and African markets requires adaptable sourcing strategies to address regional regulatory and market-specific needs.

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FAQs

1. What are the most reliable suppliers for diclofenac epolamine?
Major pharmaceutical companies such as Novartis, Sandoz, and Teva are considered the most reliable, given their strong regulatory compliance, manufacturing standards, and extensive distribution networks.

2. How do I evaluate the quality of a diclofenac epolamine supplier?
Assess their GMP certification, regulatory approvals (FDA, EMA), quality control protocols, track record of product consistency, and customer references.

3. Are there low-cost alternatives available in the market?
Yes, regional manufacturers, particularly in India and China, offer competitively priced diclofenac epolamine products, often meeting international quality standards.

4. What should be considered when sourcing from emerging manufacturers?
Evaluate their regulatory compliance, manufacturing capacity, quality assurance procedures, and their ability to meet your volume and delivery timelines.

5. How does regulatory compliance impact international sourcing?
Regulatory compliance ensures product safety, efficacy, and legal market access. Non-compliant suppliers pose risks of product recalls, legal penalties, and reputation damage.

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Sources

1. [1] Novartis official product portfolio.
2. [2] Sandoz overview – Global generic pharmaceuticals.
3. [3] Teva pharmaceutical manufacturing standards.
4. [4] Dr. Reddy’s laboratories product catalog.
5. [5] Aurobindo Pharma quality certifications and markets.