Suppliers and packagers for doral

doral

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Galt Pharms	DORAL	quazepam	TABLET;ORAL	018708	NDA AUTHORIZED GENERIC	Atland Pharmaceuticals, LLC	71993-265-30	30 TABLET in 1 BOTTLE (71993-265-30)	2018-03-20

Suppliers for the Pharmaceutical Drug: DORAL

Last updated: August 1, 2025

Introduction

DORAL, a prescription medication primarily known for its use as an anti-inflammatory and analgesic, is a branded term often associated with the pharmaceutical compound diclofenac. As a non-steroidal anti-inflammatory drug (NSAID), diclofenac is utilized globally for the management of pain, inflammatory disorders, and postoperative discomfort. Its widespread application has led to a complex landscape of suppliers, comprising both brand-name manufacturers and numerous generic producers. This article elucidates the supply chain structure, key players, manufacturing dynamics, and regulatory considerations pertinent to DORAL and its generic equivalents.

Pharmaceutical Market Overview of DORAL (Diclofenac)

DORAL, originally developed and marketed by Astellas Pharma, contains diclofenac sodium and has been marketed under various formulations including tablets, topical gels, and injectable forms. The patent protections for DORAL have long expired, opening the pharmaceutical market to generic manufacturers. The global demand for diclofenac is driven by its accessibility and cost-effectiveness, particularly in developing markets.

Market data indicate a substantial segment of the world's NSAID market, with diclofenac accounting for a significant share. According to IQVIA data, diclofenac-based products rank among the top NSAIDs by volume sales globally [1].

Manufacturers and Suppliers of DORAL

Brand-Name Manufacturers

Initially, DORAL was produced and marketed by Astellas Pharma, which gained marketing rights following the development of diclofenac formulations. However, patent exclusivity rights have now expired, shifting the landscape toward generic options.

Generic Drug Manufacturers

The expiry of key patents has paved the way for numerous generic manufacturers to produce diclofenac formulations, including products originally branded as DORAL. These companies span continents and operate under strict regulatory standards, primarily governed by agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and equivalent authorities worldwide.

Major generic suppliers include:

• Novartis AG – A significant producer of diclofenac, offering both generic and branded formulations.
• Sandoz (Novartis division) – Supplies a range of generic NSAIDs globally.
• Mylan (now part of Viatris) – Provides multiple formulations of diclofenac in both tablet and topical forms.
• Teva Pharmaceuticals – One of the world's largest generic manufacturers, with extensive diclofenac product lines.
• Pfizer – While primarily known for branded products, Pfizer distributes generic NSAIDs in various markets.
• Sun Pharmaceutical Industries – A dominant Indian manufacturer offering diclofenac in various formulations.
• Aurobindo Pharma – An Indian pharmaceutical company with a broad portfolio that includes diclofenac generics.
• Cipla – Provides affordable diclofenac formulations primarily in emerging markets.

Regional and Local Suppliers

Apart from these industry giants, numerous regional and local pharmaceutical firms manufacture diclofenac to meet local demand. These companies often obtain approvals through regulatory agencies such as the Central Drugs Standard Control Organization (CDSCO) in India or the European Medicines Agency (EMA).

Supply Chain Dynamics

The supply chain for DORAL and its generics involves multiple tiers:

• Active Pharmaceutical Ingredient (API) Suppliers:
  The backbone of manufacturing, API producers supply high-purity diclofenac sodium to finished drug formulators. Key API suppliers include:

  • Hubei Hongyuan Pharmaceutical (China)
  • Sichuan Suncare Pharmaceutical (China)
  • Akorn (now part of Fresenius Kabi) – Historically, an API supplier, though supply chain specifics vary.

• API Distribution and Exporters:
  API companies often export to generic drug manufacturers worldwide, subject to regional regulations and import/export controls.

• Finished Drug Formulators:
  These companies synthesize APIs into finished dosage forms, including tablets and topical formulations, often sourcing APIs from multiple suppliers to mitigate supply chain risks.

• Distributors and Wholesalers:
  Primary distributors operate at regional levels, ensuring supply to pharmacies and hospitals.

Regulatory and Quality Considerations

Manufacturers and suppliers must adhere to rigorous standards mandated by regulatory authorities, including Good Manufacturing Practices (GMP). The quality of diclofenac varies among suppliers, which impacts efficacy and safety. Notably, the World Health Organization (WHO) emphasizes the importance of GMP compliance among API producers, especially given the widespread use of NSAIDs [2].

Additionally, the transfer of formulations across regions often necessitates supplementary bioequivalence and stability data to satisfy local regulatory agencies.

Pricing and Market Access

Generic suppliers' pricing strategies influence accessibility and affordability, especially in low-income regions. Procurement contracts with government health agencies or private insurers can significantly affect the availability of DORAL and its equivalents. The increasing prevalence of biosimilars and generic equivalents has generally driven prices downward, making diclofenac products among the most accessible NSAIDs globally.

Emerging Trends and Challenges

• Supply Chain Disruptions:
  COVID-19 highlighted vulnerabilities within the API and finished drug supply chains, prompting diversification among API sources and increased domestic manufacturing initiatives.

• Regulatory Stringency:
  Regulatory agencies tighten approval standards for APIs and finished products, pressuring suppliers to maintain GMP compliance.

• Environmental and Safety Regulations:
  There is growing scrutiny over the environmental impact of API production, prompting suppliers to adopt cleaner manufacturing practices.

Conclusion

The supply landscape for DORAL, encapsulating diclofenac sodium-based formulations, is characterized by a diverse mix of global generic manufacturers, regional producers, and API suppliers. After patent expiry, the market has seen an influx of suppliers capable of meeting global demand but within a framework of stringent regulatory standards designed to ensure safety, efficacy, and quality. Understanding these suppliers' scope and operational standards is essential for stakeholders pursuing procurement, licensing, or strategic partnerships.

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Key Takeaways

• The removal of patent protections has diversified the supplier base for DORAL (diclofenac), fostering increased competition and accessibility.
• Major generic pharmaceutical companies like Sandoz, Mylan (Viatris), Teva, and Sun Pharma dominate the supply chain worldwide.
• API sourcing is critical, with Chinese and Indian manufacturers leading global exports.
• Regulatory compliance, especially GMP adherence, remains pivotal in ensuring product safety; suppliers vary in critical quality attributes.
• Supply chain resilience has become a priority post-pandemic, leading to initiatives for diversified API sourcing and local manufacturing.

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FAQs

1. Are generic diclofenac products interchangeable with DORAL?
Yes. Once patent protections expire, generic diclofenac products undergo bioequivalence testing, which ensures they are interchangeable with the brand-name counterpart in terms of safety and efficacy, subject to regulatory approvals.

2. How do regulatory agencies monitor suppliers of diclofenac?
Regulatory bodies such as the FDA and EMA enforce GMP standards, conduct inspections, and review manufacturing practices. API producers and finished product manufacturers must meet strict quality standards to maintain approvals.

3. What are the primary regions sourcing diclofenac APIs from China and India?
China and India are the leading exporters of diclofenac API, supplying a significant portion of global demand, supported by a robust API manufacturing infrastructure and competitive pricing.

4. How has the market evolved post-patent expiry?
The market has seen increased competition from numerous generic manufacturers, leading to lower prices and expanded availability, especially in emerging markets.

5. What future trends could affect the supply of DORAL?
Enhanced regulatory standards, environmental sustainability practices, supply chain diversification, and potential shifts toward reformulated or biosimilar products will influence future supply dynamics for diclofenac.

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References
[1] IQVIA, Global Pharma Market Data, 2022.
[2] World Health Organization, WHO Guidelines on Good Manufacturing Practice, 2021.