Suppliers and packagers for generic pharmaceutical drug: FLURBIPROFEN

FLURBIPROFEN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
New Heightsrx	FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074431	ANDA	Bryant Ranch Prepack	63629-8338-1	30 TABLET, FILM COATED in 1 BOTTLE (63629-8338-1)	1995-06-02
New Heightsrx	FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074431	ANDA	Bryant Ranch Prepack	63629-8338-2	60 TABLET, FILM COATED in 1 BOTTLE (63629-8338-2)	1995-06-02
New Heightsrx	FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074431	ANDA	Bryant Ranch Prepack	63629-8808-1	100 TABLET, FILM COATED in 1 BOTTLE (63629-8808-1)	1995-06-02
New Heightsrx	FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074431	ANDA	Genus Lifesciences	64950-218-10	100 TABLET in 1 BOTTLE (64950-218-10)	2024-11-01
New Heightsrx	FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074431	ANDA	NuCare Pharmaceuticals,Inc.	68071-4436-4	14 TABLET, FILM COATED in 1 BOTTLE (68071-4436-4)	1995-06-02
New Heightsrx	FLURBIPROFEN	flurbiprofen	TABLET;ORAL	074431	ANDA	IPG Pharmaceuticals, Inc.	71085-082-30	30 TABLET in 1 BOTTLE (71085-082-30)	2025-08-01

Flurbiprofen Pharmaceutical Drug Supplier Landscape

Last updated: February 19, 2026

This report analyzes the key suppliers of flurbiprofen, a nonsteroidal anti-inflammatory drug (NSAID). It examines their manufacturing capabilities, geographical presence, regulatory compliance, and notable market activities relevant to flurbiprofen production. Understanding this supplier ecosystem is critical for pharmaceutical companies engaged in the development, manufacturing, and procurement of flurbiprofen-containing products.

What is Flurbiprofen?

Flurbiprofen is a propionic acid derivative that functions as a nonselective inhibitor of cyclooxygenase (COX) enzymes. This mechanism leads to a reduction in prostaglandin synthesis, which mediates inflammation, pain, and fever. Flurbiprofen is primarily used for the management of pain and inflammation associated with conditions such as rheumatoid arthritis, osteoarthritis, and menstrual cramps. It is available in various formulations, including oral tablets, topical solutions, and ophthalmic drops.

Key Suppliers of Flurbiprofen API

The following entities are identified as significant manufacturers and suppliers of flurbiprofen active pharmaceutical ingredient (API).

• Solvay S.A.: A multinational chemical company with a significant pharmaceutical ingredients division. Solvay has historically been involved in the production of various APIs, including NSAIDs. Their manufacturing sites are subject to rigorous quality control and regulatory oversight. Solvay's involvement in flurbiprofen production is based on established chemical synthesis routes.
• Rhodia: Now integrated into Solvay, Rhodia was a precursor entity with expertise in fine chemicals and pharmaceutical intermediates. This integration consolidates Solvay's position in the API market.
• Teva Pharmaceutical Industries Ltd.: A global pharmaceutical company with extensive capabilities in API manufacturing and finished dosage form production. Teva's robust supply chain and regulatory expertise make them a key player. They produce a wide range of generic APIs.
• Mylan N.V. (now Viatris Inc.): Following the merger with Pfizer's Upjohn division, Mylan became part of Viatris, a global healthcare company. Viatris maintains significant API manufacturing operations and is a supplier of various generic drug components.
• Alkem Laboratories Ltd.: An Indian multinational pharmaceutical company engaged in the manufacturing of APIs and finished formulations. Alkem has a strong presence in the generics market and is known for its cost-effective API production. Their facilities are typically certified by major regulatory bodies.
• Dr. Reddy's Laboratories Ltd.: Another prominent Indian pharmaceutical company with a strong API business segment. Dr. Reddy's has a global reach and supplies APIs to regulated markets. Their focus on complex generics and differentiated products extends to their API portfolio.
• Divi’s Laboratories Limited: An Indian API manufacturer with a substantial global footprint. Divi's is known for its large-scale manufacturing capacity and strong regulatory compliance. They are a significant supplier of APIs across multiple therapeutic areas.
• Lupin Limited: An Indian multinational pharmaceutical company with diverse manufacturing capabilities, including API production. Lupin serves both regulated and emerging markets.

Manufacturing Capabilities and Technologies

Flurbiprofen API is typically synthesized through multi-step chemical processes. Key stages involve:

• Synthesis of Intermediates: This involves reactions such as Friedel-Crafts acylation and subsequent modifications to build the core flurbiprofen structure.
• Chiral Resolution (if applicable): While flurbiprofen is often sold as a racemic mixture, enantiomerically pure forms may require specific chiral separation techniques if a particular enantiomer is desired for certain applications.
• Purification: Crystallization and chromatography are commonly employed to achieve high purity standards required for pharmaceutical APIs.
• Quality Control and Assurance: Comprehensive testing using techniques like High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Mass Spectrometry (MS), and Nuclear Magnetic Resonance (NMR) is performed to ensure API identity, purity, and potency.

Suppliers invest in advanced chemical synthesis equipment, process optimization technologies, and analytical instrumentation to ensure consistent product quality and yield. Automation and continuous manufacturing principles are increasingly adopted to enhance efficiency and reduce batch-to-batch variability.

Geographical Presence and Regulatory Compliance

The production of flurbiprofen API is concentrated in regions with established chemical manufacturing infrastructure and strong regulatory frameworks.

• India: A leading global supplier of generic APIs, including flurbiprofen. Indian manufacturers benefit from cost advantages, skilled labor, and government support for the pharmaceutical sector. Key regulatory bodies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and WHO have certified numerous Indian API facilities.
• Europe: European manufacturers, such as Solvay, often focus on high-value, specialized APIs and adhere to stringent EMA regulations. Their facilities are typically FDA and EMA approved.
• United States: While some API manufacturing exists in the U.S., it often focuses on specialized or niche products. U.S.-based pharmaceutical companies may source APIs globally while maintaining rigorous oversight of their supply chains.

Regulatory Approvals:

Suppliers of flurbiprofen API must comply with Good Manufacturing Practices (GMP) as defined by international regulatory agencies. This includes:

• FDA (U.S. Food and Drug Administration): Facilities manufacturing APIs for the U.S. market must be registered with the FDA and undergo regular inspections. Drug Master Files (DMFs) are often submitted to the FDA for APIs.
• EMA (European Medicines Agency): Similar to the FDA, the EMA requires compliance with EU GMP guidelines. Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEPs) are common for APIs supplied to Europe.
• PMDA (Pharmaceuticals and Medical Devices Agency - Japan): Japanese regulatory requirements are also critical for supplying to the Japanese market.
• Other National Regulatory Authorities: Suppliers must meet the specific requirements of each country where their flurbiprofen API will be used in finished drug products.

Market Dynamics and Trends

The flurbiprofen market, like many generic APIs, is characterized by:

• Price Sensitivity: Cost of production is a significant factor, leading to competitive pricing among suppliers.
• Supply Chain Resilience: Pharmaceutical companies are increasingly focused on diversifying their supplier base to mitigate risks related to geopolitical instability, natural disasters, or manufacturing disruptions.
• Quality and Regulatory Assurance: While price is important, unwavering quality and regulatory compliance are non-negotiable. Companies prioritize suppliers with a strong track record of inspections and audits.
• Intellectual Property: While the primary patents for flurbiprofen have long expired, process patents for novel synthesis routes or improved purification methods can still influence market dynamics.

Emerging Players and Technological Advancements

While the core flurbiprofen API market is mature, advancements in chemical synthesis and manufacturing technologies can lead to new entrants or enhance the capabilities of existing suppliers.

• Green Chemistry Initiatives: Suppliers are exploring more environmentally friendly synthesis routes, reducing solvent usage, and minimizing waste generation.
• Continuous Manufacturing: The adoption of continuous flow chemistry offers potential advantages in terms of process control, product consistency, and scalability for API production.
• Advanced Analytical Techniques: Improved analytical methods allow for more sensitive detection of impurities and better characterization of the API, ensuring higher quality.

Key Takeaways

• The flurbiprofen API supply chain is dominated by established generic API manufacturers, primarily located in India, with significant European participation.
• Key suppliers include Solvay, Teva, Viatris, Alkem Laboratories, Dr. Reddy's Laboratories, Divi’s Laboratories, and Lupin.
• Regulatory compliance with GMP standards from agencies like the FDA and EMA is a critical prerequisite for suppliers.
• Market dynamics are driven by price competition, with a growing emphasis on supply chain resilience and stringent quality control.
• Technological advancements in green chemistry and continuous manufacturing represent potential areas for future innovation and differentiation in flurbiprofen API production.

Frequently Asked Questions

1. Which geographical regions are the primary hubs for flurbiprofen API manufacturing?

India and Europe are the primary regions for flurbiprofen API manufacturing. India leads in large-scale, cost-effective production, while European manufacturers often focus on specialized synthesis and adhere to stringent regional regulations.

2. What are the typical regulatory requirements for flurbiprofen API suppliers?

Suppliers must adhere to Good Manufacturing Practices (GMP) as defined by major regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This includes site registration, facility inspections, and often the submission of Drug Master Files (DMFs) or Certificates of Suitability (CEPs).

3. How do suppliers ensure the quality and purity of flurbiprofen API?

Quality and purity are ensured through rigorous in-process controls and final product testing. This involves sophisticated analytical techniques such as HPLC, GC, MS, and NMR to verify identity, potency, and the absence of impurities, meeting pharmacopoeial standards.

4. What are the major trends impacting the flurbiprofen API supply market?

Major trends include increasing demand for supply chain resilience, a strong focus on cost-effectiveness driven by generic competition, and the adoption of advanced manufacturing technologies like green chemistry and continuous manufacturing to improve efficiency and environmental impact.

5. How does intellectual property affect the flurbiprofen API market?

While the original patents for flurbiprofen itself have expired, companies may hold patents related to novel synthesis processes, purification methods, or specific polymorphic forms of the API. These process patents can offer a competitive advantage and influence the market for specific manufacturing routes.

Citations

[1] U.S. Food and Drug Administration. (n.d.). U.S. Food and Drug Administration. Retrieved from https://www.fda.gov/

[2] European Medicines Agency. (n.d.). European Medicines Agency. Retrieved from https://www.ema.europa.eu/

[3] Solvay S.A. (n.d.). Solvay. Retrieved from https://www.solvay.com/

[4] Teva Pharmaceutical Industries Ltd. (n.d.). Teva Pharmaceuticals. Retrieved from https://www.tevapharm.com/

[5] Viatris Inc. (n.d.). Viatris. Retrieved from https://www.viatris.com/

[6] Alkem Laboratories Ltd. (n.d.). Alkem Laboratories. Retrieved from https://www.alkem.com/

[7] Dr. Reddy's Laboratories Ltd. (n.d.). Dr. Reddy's Laboratories. Retrieved from https://www.drreddys.com/

[8] Divi’s Laboratories Limited. (n.d.). Divi’s Laboratories. Retrieved from https://www.divislabs.com/

[9] Lupin Limited. (n.d.). Lupin. Retrieved from https://www.lupin.com/