Suppliers and packagers for generic pharmaceutical drug: KETOPROFEN

KETOPROFEN

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	KETOPROFEN	ketoprofen	CAPSULE, EXTENDED RELEASE;ORAL	075679	ANDA	Mylan Pharmaceuticals Inc.	0378-8200-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-8200-01)	2003-09-04
Misemer	KETOPROFEN	ketoprofen	CAPSULE;ORAL	074014	ANDA	Misemer Pharmaceuticals, Inc.	0276-0504-10	100 CAPSULE in 1 BOTTLE (0276-0504-10)	2019-06-19
Misemer	KETOPROFEN	ketoprofen	CAPSULE;ORAL	074014	ANDA	Misemer Pharmaceuticals, Inc.	0276-0506-10	100 CAPSULE in 1 BOTTLE (0276-0506-10)	2022-09-13

Ketoprofen Drug Suppliers Analysis

Last updated: February 19, 2026

This report identifies key suppliers of ketoprofen, a nonsteroidal anti-inflammatory drug (NSAID). It details their manufacturing capabilities, regulatory standing, and market presence to inform R&D and investment decisions.

What is Ketoprofen?

Ketoprofen is a propionic acid derivative NSAID used to treat pain, inflammation, and fever. It functions by inhibiting cyclooxygenase (COX) enzymes, thereby reducing prostaglandin synthesis. Approved for human and veterinary use, it is available in oral, topical, and injectable formulations. Its primary therapeutic indications include osteoarthritis, rheumatoid arthritis, and acute musculoskeletal injuries.

Key Ketoprofen Suppliers

The market for ketoprofen active pharmaceutical ingredient (API) is served by a mix of established pharmaceutical manufacturers and specialized chemical synthesis companies. Supplier selection is critical due to the stringent regulatory requirements for API production, including Good Manufacturing Practices (GMP) and adherence to pharmacopeial standards (e.g., USP, EP).

• Thermo Fisher Scientific:

  • Capabilities: Offers ketoprofen as a research chemical and for small-scale manufacturing. Primarily targets R&D laboratories and academic institutions.
  • Regulatory Standing: While not typically a large-scale GMP API supplier for commercial drugs, its products meet analytical and research purity standards.
  • Market Presence: Broad distribution network for laboratory chemicals.

• Akorn Pharmaceuticals:

  • Capabilities: Known for manufacturing finished dosage forms of various generic pharmaceuticals. May have internal API sourcing or contract manufacturing arrangements for ketoprofen.
  • Regulatory Standing: Operates under FDA and other regulatory body oversight for finished drug products.
  • Market Presence: Established generic drug manufacturer in the US.

• Mylan N.V. (now Viatris):

  • Capabilities: A global generics and specialty pharmaceuticals company. Has a broad API portfolio and manufacturing capacity.
  • Regulatory Standing: Maintains extensive global GMP certifications and regulatory filings.
  • Market Presence: Significant presence in the generic drug market worldwide.

• Sanofi S.A.:

  • Capabilities: Historically a major developer and manufacturer of NSAIDs, including ketoprofen (e.g., brand name Orudis). Possesses significant API manufacturing infrastructure.
  • Regulatory Standing: Holds numerous international GMP approvals and drug master files (DMFs).
  • Market Presence: Global pharmaceutical leader with a long history in pain management.

• Sun Pharmaceutical Industries Ltd.:

  • Capabilities: India-based global pharmaceutical company with extensive API manufacturing capabilities. Produces a wide range of APIs for generic drugs.
  • Regulatory Standing: Operates multiple FDA-inspected facilities and holds numerous international regulatory approvals.
  • Market Presence: One of the largest generic pharmaceutical companies globally.

• Lupin Limited:

  • Capabilities: Another leading Indian pharmaceutical company with a strong focus on API manufacturing for generic markets.
  • Regulatory Standing: Complies with global regulatory standards, including those of the FDA and EMA.
  • Market Presence: Operates in over 100 countries.

• Hetero Drugs Limited:

  • Capabilities: A major Indian API manufacturer with significant production capacity for various therapeutic categories.
  • Regulatory Standing: Possesses multiple manufacturing sites approved by regulatory agencies worldwide.
  • Market Presence: One of the largest API producers in India.

• IOL Chemicals and Pharmaceuticals Limited:

  • Capabilities: Specializes in the production of bulk drugs and industrial chemicals. Is a significant producer of ibuprofen and has been expanding its API portfolio.
  • Regulatory Standing: Holds DMFs with regulatory authorities and operates GMP-compliant facilities.
  • Market Presence: Exports its products globally.

Manufacturing Processes and Quality Control

Ketoprofen is typically synthesized through multi-step organic chemical processes. Common synthetic routes involve reactions starting from precursors like 2-bromopropiophenone or related aromatic compounds, followed by functional group transformations.

Typical Synthesis Pathway Elements:

1. Friedel-Crafts Acylation: Introduction of an acyl group onto an aromatic ring.
2. Halogenation: Introduction of a halogen atom.
3. Grignard Reaction or Related Organometallic Coupling: Formation of carbon-carbon bonds.
4. Oxidation/Hydrolysis: Conversion of intermediate functional groups to the carboxylic acid.

Key Quality Control Parameters for Ketoprofen API:

• Assay: Purity of ketoprofen, typically required to be between 98.0% and 102.0% on a dried basis, as per USP and EP monographs.
• Related Substances/Impurities: Limits on specific known impurities and total impurities. This includes process-related impurities and degradation products. For example, USP lists limits for p-chloroketoprofen.
• Heavy Metals: Limits on elemental impurities, often determined by ICH Q3D guidelines.
• Residual Solvents: Limits on solvents used during synthesis, as defined by ICH Q3C.
• Water Content: Typically determined by Karl Fischer titration, with specific limits defined by pharmacopeias.
• Loss on Drying: Measures volatile matter.
• Particle Size Distribution: Important for formulation and dissolution rates, particularly for solid oral dosage forms.
• Polymorphism: Different crystalline forms can affect bioavailability and stability.

Suppliers must provide Certificates of Analysis (CoA) detailing these parameters for each batch. Audits of manufacturing sites are standard practice for pharmaceutical companies sourcing API.

Regulatory Landscape for Ketoprofen API

The production and supply of ketoprofen API are subject to stringent global regulatory oversight. Key aspects include:

• Good Manufacturing Practices (GMP): Manufacturers must adhere to GMP guidelines established by regulatory bodies such as the U.S. Food and Drug Administration (FDA) (21 CFR Parts 210 & 211), the European Medicines Agency (EMA), and the World Health Organization (WHO). These regulations cover all aspects of production, from raw material sourcing to finished product release.
• Drug Master Files (DMFs): API manufacturers commonly file DMFs with regulatory agencies. A DMF is a submission to a regulatory agency (like the FDA) that provides confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. The DMF is incorporated by reference into a drug product application (NDA, ANDA).
• Pharmacopeial Standards: Ketoprofen must meet the purity and quality specifications outlined in relevant pharmacopeias, such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP).
• ICH Guidelines: Compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines is essential. Key guidelines include ICH Q3A (Impurities in New Drug Substances), Q3C (Residual Solvents), Q3D (Elemental Impurities), and Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients).
• Inspections and Audits: Regulatory agencies conduct inspections of API manufacturing facilities to ensure compliance with GMP. Pharmaceutical companies also conduct their own quality audits of potential suppliers.

Market Dynamics and Pricing

The ketoprofen API market is primarily driven by the demand for generic oral formulations. Pricing is influenced by several factors:

• Manufacturing Costs: Raw material costs, synthesis complexity, energy prices, and labor costs in the country of origin.
• Scale of Production: Larger production volumes generally lead to lower per-unit costs.
• Regulatory Compliance: Investment in GMP-compliant facilities and quality systems adds to overhead.
• Competition: The presence of multiple suppliers, particularly from India and China, contributes to competitive pricing.
• Supply Chain Disruptions: Geopolitical events, trade policies, and raw material shortages can impact availability and price.

Specific pricing for ketoprofen API is subject to contractual agreements and fluctuates based on market conditions. Bulk pricing can range from approximately $30 to $100 per kilogram, depending on purity, volume, and supplier.

Future Trends and Considerations

The pharmaceutical industry's increasing emphasis on supply chain resilience, quality assurance, and regulatory compliance will continue to shape the ketoprofen API market.

• Diversification of Supply Chains: Companies are seeking to diversify their supplier base to mitigate risks associated with single-source dependency.
• Enhanced Traceability: Greater demand for end-to-end traceability of APIs from raw materials to finished product.
• Sustainability: Growing interest in greener manufacturing processes and reduced environmental impact.
• Continuous Manufacturing: Potential adoption of continuous manufacturing processes for increased efficiency and quality control.

Companies looking to secure ketoprofen API should conduct thorough due diligence on potential suppliers, focusing on their regulatory history, quality systems, manufacturing capacity, and financial stability.

Key Takeaways

• The ketoprofen API market is served by global pharmaceutical manufacturers and specialized chemical synthesis companies, with significant supply originating from India and China.
• Key suppliers include Sanofi, Sun Pharmaceutical Industries, Lupin Limited, and Hetero Drugs Limited, alongside other players with varying capacities.
• Adherence to GMP, pharmacopeial standards (USP, EP), and ICH guidelines is mandatory for API manufacturers.
• Regulatory filings (DMFs) and successful regulatory inspections are critical indicators of supplier reliability.
• Market pricing is competitive, influenced by manufacturing costs, production scale, and global supply dynamics.
• Future trends point towards increased focus on supply chain resilience, traceability, and sustainable manufacturing practices.

Frequently Asked Questions

What are the primary regulatory bodies governing ketoprofen API production?

The primary regulatory bodies include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national health authorities in other key markets. The International Council for Harmonisation (ICH) also sets influential guidelines.

How does particle size distribution impact ketoprofen formulations?

Particle size distribution is crucial for solid oral dosage forms as it affects dissolution rates, bioavailability, and uniformity of content. Different formulations may require specific particle size ranges.

What is the typical shelf life for ketoprofen API?

The shelf life for ketoprofen API is generally between two and five years, depending on the manufacturer's stability studies, packaging, and storage conditions. Manufacturers provide specific expiry dates on batch documentation.

Can ketoprofen API be sourced from countries with less stringent regulatory oversight?

While cost savings may be a consideration, sourcing API from countries with less stringent regulatory oversight poses significant quality and compliance risks. Pharmaceutical companies must ensure their API suppliers meet the GMP standards of the target markets for their finished drug products.

What are the main types of impurities found in ketoprofen API?

Main types of impurities include related substances from the synthesis process (e.g., unreacted starting materials, intermediates, side-reaction products like p-chloroketoprofen), degradation products formed during storage, residual solvents, and elemental impurities.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from https://www.fda.gov/drugs/pharmaceutical-quality-regulation/current-good-manufacturing-practice-cgmp-regulations [2] European Medicines Agency. (n.d.). Good manufacturing practice. Retrieved from https://www.ema.europa.eu/en/human-regulatory-information/research-and-development/scientific-advice-procedural-guidance/good-manufacturing-practice [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from https://www.ich.org/page/guidelines [4] United States Pharmacopeia. (n.d.). Ketoprofen Monograph. USP-NF. [5] European Pharmacopoeia. (n.d.). Ketoprofen Monograph. Ph. Eur.