Suppliers and packagers for diflunisal

diflunisal

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Heritage Pharma	DIFLUNISAL	diflunisal	TABLET;ORAL	202845	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	14539-673-01	100 TABLET, FILM COATED in 1 BOTTLE (14539-673-01)	2012-03-08
Heritage Pharma	DIFLUNISAL	diflunisal	TABLET;ORAL	202845	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	14539-673-05	500 TABLET, FILM COATED in 1 BOTTLE (14539-673-05)	2012-03-08
Heritage Pharma	DIFLUNISAL	diflunisal	TABLET;ORAL	202845	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	14539-673-06	60 TABLET, FILM COATED in 1 BOTTLE (14539-673-06)	2012-03-08
Heritage Pharma	DIFLUNISAL	diflunisal	TABLET;ORAL	202845	ANDA	Chartwell RX, LLC	62135-456-60	60 TABLET, FILM COATED in 1 BOTTLE (62135-456-60)	2012-03-08
Heritage Pharma	DIFLUNISAL	diflunisal	TABLET;ORAL	202845	ANDA	INA Pharmaceutics Inc	74157-009-60	60 TABLET, FILM COATED in 1 BOTTLE (74157-009-60)	2024-08-19
Heritage Pharma	DIFLUNISAL	diflunisal	TABLET;ORAL	202845	ANDA	INA Pharmaceutics Inc	74157-101-60	60 TABLET, FILM COATED in 1 BOTTLE (74157-101-60)	2024-08-19
Teva	DIFLUNISAL	diflunisal	TABLET;ORAL	073673	ANDA	Teva Pharmaceuticals USA, Inc.	0093-9222-01	100 TABLET, FILM COATED in 1 BOTTLE (0093-9222-01)	2021-06-30

Diflunisal Suppliers: Market Landscape and Key Players

Last updated: February 19, 2026

This analysis identifies and profiles key suppliers of diflunisal active pharmaceutical ingredient (API). Diflunisal is a nonsteroidal anti-inflammatory drug (NSAID) used for pain management. The supply chain for diflunisal API is characterized by a limited number of manufacturers, primarily located in Asia, serving a global market. Key considerations for procurement include regulatory compliance, quality assurance, and supply chain reliability.

Who are the primary manufacturers and suppliers of Diflunisal API?

The global supply of diflunisal API is concentrated among a few manufacturers. These entities are responsible for synthesizing the drug substance and supplying it to pharmaceutical companies for formulation into finished dosage forms. The primary geographical hubs for diflunisal API production are India and China, reflecting the broader trend in global API manufacturing.

Key identified suppliers include:

• Divi's Laboratories Ltd. is a prominent Indian API manufacturer with a broad portfolio. The company supplies various therapeutic categories, and diflunisal is part of its offering. Divi's operates multiple manufacturing facilities in India, adhering to stringent quality and regulatory standards.
• Neuland Laboratories Ltd. is another Indian API producer. Neuland specializes in custom manufacturing and generic APIs. The company has a strong regulatory track record and supplies to regulated markets. Diflunisal is listed as one of their products.
• Loba Chemie Pvt. Ltd., based in India, supplies laboratory reagents and fine chemicals, including pharmaceutical intermediates and APIs like diflunisal. While Loba Chemie also serves research and development needs, it acts as a supplier for bulk API as well.
• Chemantha Laboratories is a manufacturer and exporter of APIs, including diflunisal. Located in India, the company emphasizes quality control and regulatory adherence.
• Specific Chinese manufacturers also play a role, though their names may be less consistently publicized in readily accessible global market intelligence. These entities operate within China's established chemical and pharmaceutical manufacturing sector. Due diligence is crucial when engaging with these suppliers.

These suppliers cater to a global client base, including generic drug manufacturers and contract manufacturing organizations (CMOs) in North America, Europe, and Asia. The competitive landscape is influenced by cost of production, regulatory approvals (e.g., US FDA, EMA), and the ability to ensure consistent quality and supply.

What is the regulatory status and compliance framework for Diflunisal API suppliers?

Suppliers of diflunisal API must adhere to a rigorous regulatory framework to ensure product safety, efficacy, and quality. This framework is primarily dictated by the health authorities of the target markets where the finished drug products will be sold.

Key regulatory aspects include:

• Good Manufacturing Practices (GMP): All diflunisal API manufacturers must comply with cGMP as defined by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). GMP ensures that products are consistently produced and controlled according to quality standards.
  • FDA cGMP regulations are outlined in 21 CFR Parts 210 and 211.
  • EMA guidelines are published by the European Commission.
• Drug Master Files (DMFs): API suppliers typically file DMFs with regulatory authorities. A DMF is a submission to regulatory agencies (like the FDA) that provides confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows drug product manufacturers to reference the DMF in their own applications without disclosing proprietary information.
  • FDA DMF Type II is relevant for drug substances.
  • Active Substance Master Files (ASMFs) are used in Europe.
• Inspections and Audits: Regulatory agencies conduct inspections of API manufacturing facilities to verify GMP compliance. Pharmaceutical companies also conduct their own supplier audits as part of their quality management systems.
  • FDA inspections are periodic and triggered by applications or risk assessments.
  • EMA relies on national competent authorities within member states for inspections.
• Quality Agreements: Suppliers and their customers enter into quality agreements that define the responsibilities of each party concerning the quality of the API. This includes specifications, testing methods, change control, and complaint handling.
• Impurity Profiling and Control: Suppliers must demonstrate robust control over impurities in diflunisal API, including process-related impurities and degradation products, to meet pharmacopoeial standards (e.g., USP, EP) and regulatory limits.
• Certificates of Analysis (CoA): Each batch of diflunisal API supplied must be accompanied by a CoA detailing its testing results against agreed-upon specifications.

Suppliers with a strong history of successful regulatory inspections and a comprehensive quality management system are preferred by pharmaceutical companies.

What are the critical quality attributes and specifications for Diflunisal API?

The quality of diflunisal API is paramount for the safety and efficacy of the final drug product. Manufacturers must adhere to strict specifications, often defined by pharmacopoeias and customer requirements.

Key quality attributes and specifications include:

• Assay: The purity of diflunisal, typically expressed as a percentage.
  • Example Specification: Not less than 98.0% and not more than 102.0% of C15H11ClF2O2, calculated on the dried basis. (Based on typical pharmacopoeial requirements).
• Identification: Tests to confirm the identity of the substance.
  • Methods: Infrared (IR) spectroscopy, High-Performance Liquid Chromatography (HPLC) retention time matching.
• Related Substances/Impurities: Limits for known and unknown impurities. This is a critical area due to potential toxicity.
  • Example Specifications:
    • Specific identified impurities (e.g., known synthetic intermediates or degradation products) may have individual limits, often < 0.1% or < 0.2%.
    • Any unspecified impurity: Not more than 0.10%.
    • Total impurities: Not more than 1.0% or 1.5% (depending on pharmacopoeia and customer requirements).
• Loss on Drying: Measures the amount of volatile matter (primarily water) present in the API.
  • Example Specification: Not more than 0.5%.
• Residue on Ignition (Sulfated Ash): Measures inorganic impurities.
  • Example Specification: Not more than 0.1%.
• Heavy Metals: Limits for heavy metal contamination.
  • Example Specification: Not more than 10 ppm or 20 ppm.
• Residual Solvents: Limits for solvents used during synthesis, as per ICH Q3C guidelines.
  • Example Specifications: Vary based on the specific solvent class and toxicity (e.g., Class 1 solvents are highly restricted, Class 2 and 3 have higher permissible limits).
• Particle Size Distribution: For solid APIs, particle size can impact dissolution rate and bioavailability. This specification is often defined by the customer based on formulation needs.
• Chirality: Diflunisal is a chiral molecule, existing as enantiomers. Specifications may define the enantiomeric purity if one enantiomer is therapeutically preferred or if specific chiral impurities are a concern. However, diflunisal is typically used as a racemic mixture.

Pharmacopoeial monographs (e.g., United States Pharmacopeia - USP, European Pharmacopoeia - EP) provide official standards that suppliers must meet. Customers may also impose tighter in-house specifications.

What are the supply chain risks and mitigation strategies for Diflunisal?

The supply chain for diflunisal API, like many APIs, faces several inherent risks that can impact availability, cost, and quality.

Identified Supply Chain Risks:

• Geographic Concentration: Reliance on a limited number of suppliers, particularly in specific regions like India and China, creates vulnerability to geopolitical instability, natural disasters, or localized regulatory enforcement actions.
  • Example: A severe environmental crackdown in a major Chinese chemical production hub could disrupt output.
• Regulatory Non-Compliance: A supplier's failure to maintain GMP standards or pass regulatory inspections can lead to product recalls, import bans, or the inability to supply to regulated markets.
  • Example: FDA warning letters issued to an API facility can halt shipments.
• Quality Deviations: Batch failures, out-of-specification results, or cross-contamination incidents can lead to production delays and increased costs for the drug product manufacturer.
  • Example: Discovery of a new, harmful impurity may necessitate extensive retesting and process validation.
• Intellectual Property (IP) Issues: While diflunisal is an older drug and likely off-patent in most jurisdictions, patent expiry can lead to increased competition, but also potential disputes over manufacturing processes if new patented routes are developed.
• Raw Material Shortages: The synthesis of diflunisal requires specific starting materials and reagents. Shortages or price volatility of these precursors can affect API production costs and availability.
• Logistical Disruptions: Global shipping delays, increased freight costs, or customs issues can impact timely delivery of API.
• Economic Factors: Currency fluctuations, inflation, and changes in labor costs can affect the overall cost of API production and procurement.

Mitigation Strategies:

• Dual Sourcing: Qualifying and maintaining relationships with at least two independent API suppliers in different geographic regions.
  • Action: Implement a robust supplier qualification program that includes site audits and batch testing for all potential suppliers.
• Inventory Management: Maintaining strategic buffer stocks of critical APIs at the finished product manufacturing sites or through third-party logistics providers.
  • Action: Conduct a supply chain risk assessment to determine optimal safety stock levels based on lead times, demand variability, and supplier reliability.
• Supplier Audits and Monitoring: Conducting regular, in-depth audits of key suppliers' manufacturing facilities and quality systems. Continuous monitoring of regulatory filings and public announcements related to suppliers.
  • Action: Establish a supplier scorecard system to track key performance indicators such as on-time delivery, quality complaints, and audit findings.
• Robust Quality Agreements: Clearly defined quality agreements that outline responsibilities, change control procedures, and dispute resolution mechanisms.
  • Action: Ensure quality agreements are legally reviewed and regularly updated to reflect current operational realities.
• Process Understanding and Control: For critical APIs, having a deep understanding of the supplier's manufacturing process and controls. This allows for better assessment of risks and more effective troubleshooting.
  • Action: Invest in process validation studies and impurity profiling to ensure consistent API quality.
• Long-Term Contracts: Negotiating long-term supply agreements with key suppliers to secure pricing and ensure commitment.
  • Action: Structure contracts to include provisions for price adjustments based on mutually agreed-upon indices and for volume commitments.
• Diversification of Raw Material Sources: For critical starting materials used in diflunisal synthesis, securing multiple suppliers.

By proactively addressing these risks, pharmaceutical companies can enhance the resilience and reliability of their diflunisal supply chain.

What is the market outlook and competitive landscape for Diflunisal API?

The market for diflunisal API is mature and largely driven by the demand for generic diflunisal products. As a well-established NSAID, diflunisal faces competition from a wide array of other pain relief medications, including other NSAIDs, acetaminophen, and opioids.

Market Dynamics:

• Generic Market: The primary driver for diflunisal API demand is the generic pharmaceutical market. Growth in this segment is influenced by healthcare access, aging populations, and the cost-effectiveness of generic drugs.
• Competition from Other NSAIDs: Diflunisal competes with a broad class of NSAIDs (e.g., ibuprofen, naproxen, diclofenac, celecoxib) and other analgesics. Market share is influenced by efficacy, safety profiles, pricing, and physician prescribing habits.
• Therapeutic Area Growth: While diflunisal is primarily used for mild to moderate pain and inflammation, its overall market penetration is limited compared to blockbuster pain relievers.
• Regulatory Environment: The global regulatory landscape for pharmaceuticals, including stringent quality requirements for APIs, continues to shape the competitive environment. Manufacturers must invest in compliance to remain competitive.
• Pricing Pressures: The generic nature of diflunisal products leads to significant pricing pressures throughout the supply chain, from API manufacturing to finished product distribution.

Competitive Landscape Analysis:

• Limited Number of Major API Manufacturers: As identified, the number of large-scale, reliable diflunisal API manufacturers is relatively small. This can lead to concentrated market power for these suppliers.
• Role of Chinese and Indian Manufacturers: These countries dominate API production due to cost advantages, established chemical industries, and skilled workforces. However, increasing scrutiny on environmental regulations and quality standards in these regions can impact supply.
• Emergence of New Players: While less likely for a mature product like diflunisal, new entrants could emerge, particularly if they can achieve cost efficiencies or novel synthesis routes. However, the high barrier to entry in terms of regulatory approval and established supply relationships makes this challenging.
• Contract Manufacturing Organizations (CMOs): CMOs play a role in both API synthesis and finished drug product manufacturing. Companies that specialize in NSAID production or have robust regulatory capabilities are key players.
• Intellectual Property Landscape: Diflunisal's primary patents have long expired, meaning that generic competition is the norm. Companies may seek to differentiate through improved formulations or novel delivery systems, but the API itself is generally a commodity product.

The outlook for the diflunisal API market is stable, with demand closely tied to the performance of generic diflunisal formulations. Companies seeking to enter or expand in this space must focus on cost efficiency, robust quality systems, and secure supply chain management to compete effectively against established players.

Key Takeaways

• The global supply of diflunisal API is concentrated among a few manufacturers, primarily in India and China.
• Key suppliers include Divi's Laboratories, Neuland Laboratories, Loba Chemie, and Chemantha Laboratories, with additional contributions from Chinese producers.
• Suppliers must comply with stringent global regulatory standards, including cGMP, and maintain up-to-date Drug Master Files.
• Critical quality attributes for diflunisal API include assay, impurity profile, loss on drying, and residue on ignition, as defined by pharmacopoeias.
• Supply chain risks are significant and include geographic concentration, regulatory non-compliance, and quality deviations; mitigation requires dual sourcing, inventory management, and robust quality agreements.
• The diflunisal API market is mature and driven by generic demand, facing competition from other NSAIDs and analgesics, with pricing pressures being a significant factor.

Frequently Asked Questions

What are the primary applications of diflunisal?

Diflunisal is primarily used for the relief of mild to moderate pain and for the management of pain and inflammation associated with osteoarthritis and rheumatoid arthritis.

How does diflunisal compare to other NSAIDs in terms of efficacy and safety?

Diflunisal is a propionic acid derivative NSAID with a longer half-life compared to some other NSAIDs, allowing for less frequent dosing. Its efficacy is comparable to other NSAIDs for pain and inflammation, but like all NSAIDs, it carries risks of gastrointestinal bleeding, cardiovascular events, and renal impairment, particularly with long-term use or in susceptible individuals.

What are the typical lead times for procuring diflunisal API from major suppliers?

Typical lead times for diflunisal API can range from 2 to 6 months, depending on the supplier's production schedule, order volume, and current market demand. Urgent orders may incur premium pricing or require expedited manufacturing slots.

Are there any specific environmental or sustainability considerations for diflunisal API manufacturing?

As with all chemical manufacturing, diflunisal API production involves the use of solvents and reagents that require careful waste management and disposal to minimize environmental impact. Manufacturers are increasingly expected to adhere to sustainable chemistry principles, reduce energy consumption, and minimize emissions.

What is the typical pricing structure for diflunisal API?

Pricing for diflunisal API is subject to negotiation and influenced by order volume, purity specifications, regulatory compliance status of the supplier, and prevailing market conditions. Bulk purchases generally command lower per-kilogram pricing compared to smaller, non-contractual orders.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (cGMP) in Manufacturing, Processing, Packing, or Holding of Drugs; General. 21 CFR Part 210. [2] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice for Finished Pharmaceuticals. 21 CFR Part 211. [3] European Medicines Agency. (n.d.). EudraLex - The Rules Governing Medicinal Products in the European Union. Volume 4. [4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2015). ICH Harmonised Tripartite Guideline Impurities: Guideline for Residual Solvents Q3C(R6). [5] United States Pharmacopeia. (n.d.). Diflunisal. In United States Pharmacopeia and National Formulary.