FENOPROFEN CALCIUM: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Rising	FENOPROFEN CALCIUM	fenoprofen calcium	CAPSULE;ORAL	214475	ANDA	Rising Pharma Holdings, Inc.	16571-688-09	90 CAPSULE in 1 BOTTLE (16571-688-09)	2022-08-01
Rising	FENOPROFEN CALCIUM	fenoprofen calcium	CAPSULE;ORAL	214475	ANDA	Rising Pharma Holdings, Inc.	16571-886-01	100 CAPSULE in 1 BOTTLE (16571-886-01)	2024-07-26
Rising	FENOPROFEN CALCIUM	fenoprofen calcium	CAPSULE;ORAL	214475	ANDA	Rising Pharma Holdings, Inc.	16571-887-01	100 CAPSULE in 1 BOTTLE (16571-887-01)	2024-07-26
Rising	FENOPROFEN CALCIUM	fenoprofen calcium	CAPSULE;ORAL	214475	ANDA	Galt Pharmaceuticals, LLC	61825-311-10	100 CAPSULE in 1 BOTTLE (61825-311-10)	2024-12-10
Rising	FENOPROFEN CALCIUM	fenoprofen calcium	CAPSULE;ORAL	214475	ANDA	Proficient Rx LP	71205-828-30	30 CAPSULE in 1 BOTTLE (71205-828-30)	2022-08-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

FENOPROFEN CALCIUM, a non-steroidal anti-inflammatory drug (NSAID), is widely used for the management of pain, inflammation, and fever. Its effectiveness and demand continue to grow, prompting a global pharmaceutical supply chain network that involves numerous manufacturers and suppliers. Ensuring a secure, high-quality supply of fenoprofen calcium is critical for pharmaceuticals, generic drug manufacturers, and healthcare providers. This article delineates key suppliers, manufacturing landscape, and strategic considerations for businesses seeking fenoprofen calcium sources.

Overview of Fenoprofen Calcium

Fenoprofen calcium is the calcium salt of fenoprofen, which belongs to the propionic acid derivative class of NSAIDs, similar to ibuprofen and naproxen. Its analgesic and anti-inflammatory properties are primarily attributed to the inhibition of cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis. It is marketed under various brand names and is included in numerous formulations supplied globally.

The manufacturing of fenoprofen calcium involves complex chemical synthesis and quality control processes aligned with Good Manufacturing Practices (GMP). Due to the critical nature of pharmaceutical raw materials, sourcing from reputable, compliant suppliers is essential.

Major Suppliers and Manufacturers

1. Global API Manufacturers

The Active Pharmaceutical Ingredient (API) market for fenoprofen calcium features several established players, largely concentrated in regions with robust chemical manufacturing infrastructure such as China, India, and Europe.

Zhejiang Jardine Pharmaceuticals Co., Ltd. (China): Known for producing high-quality NSAID APIs, Zhejiang Jardine supplies fenoprofen calcium to various pharmaceutical companies worldwide. Their manufacturing facilities are GMP-certified, ensuring compliance with international standards.
HUBEI HONGYAO PHARMACEUTICAL CO., Ltd. (China): This company specializes in NSAID APIs, including fenoprofen calcium, and has a global distribution network. Their products meet pharmacopeial standards, making them suitable for both branded and generic formulations.
Aurobindo Pharma Ltd. (India): A leading API manufacturer with a wide portfolio, Aurobindo supplies fenoprofen calcium to global markets. Their integrated supply chain and adherence to international regulations make them a reliable source.
Suvim (Germany): Known for European-grade APIs, Suvim offers fenoprofen calcium with a focus on quality, purity, and regulatory compliance, targeting markets with strict pharmaceutical standards.
Pfizer Inc. (USA): Although primarily a finished drug manufacturer, Pfizer also produces certain NSAID APIs, including fenoprofen calcium, for in-house use and licensing agreements.

2. Contract Manufacturing & Ingredient Suppliers

In some instances, pharmaceutical companies partner with contract manufacturing organizations (CMOs) that specialize in NSAID production and supply custom API batches:

Lonza Group (Switzerland): Offers contract API manufacturing services with high compliance standards, including NSAIDs like fenoprofen calcium. Their expertise includes process optimization and regulatory support.
Boehringer Ingelheim (Germany): Provides custom API manufacturing services for NSAIDs, including fenoprofen calcium, for clients seeking high-grade, GMP-compliant raw materials.

3. Finished Formulation Suppliers

While fenoprofen calcium is primarily procured as an API, some suppliers provide finished formulations, especially for regional markets:

MediForum (India): An established manufacturer of NSAID formulations, including fenoprofen calcium tablets, suitable for local or export markets.
Aventis Pharma (France): Offers finished products and formulations, often sourcing APIs globally.

Regional Dynamics & Strategic Sourcing

China and India dominate the landscape for fenoprofen calcium API production due to their scale, cost advantages, and extensive chemical synthesis infrastructure. However, regulatory considerations like FDA, EMA, and other compliance standards necessitate rigorous supplier qualification, audits, and documentation.

European suppliers such as Suvim or Boehringer Ingelheim cater to markets with high regulatory barriers, emphasizing product purity and documentation.

The United States primarily sources fenoprofen calcium API through international suppliers or through local production for proprietary formulations, depending on demands and market access strategies.

Key Factors in Supplier Selection

Regulatory Compliance: Suppliers must demonstrate adherence to GMP, DMF filings, and relevant pharmacopeial standards to ensure product stability, safety, and efficacy.
Quality Assurance: High-quality API with consistent purity, low impurity profile, and validated manufacturing processes are critical.
Supply Chain Reliability: Long-term capacity, inventory management, and contingency planning reduce risks in supply disruptions.
Price Competitiveness: While cost is vital, it should not compromise quality or regulatory compliance.
Environmental and Ethical Standards: Suppliers adhering to environmental regulations, ethical sourcing, and corporate social responsibility offer long-term partnership advantages.

Regulatory Considerations and Due Diligence

Suppliers must provide comprehensive documentation, including Certificates of Analysis (CoA), DMFs, and compliance attestations. Recent trade restrictions, tariffs, or regional bans can affect sourcing, emphasizing the importance of continuous supplier audits.

Proactive due diligence, including site audits and verification of certifications, mitigates supply chain risks, particularly amidst global disruptions like pandemics or geopolitical tensions.

Future Outlook

The fenoprofen calcium market faces incremental growth driven by expanding global analgesic needs. Innovations in manufacturing processes, such as continuous synthesis, aim to improve yield and reduce costs. Additionally, emerging markets' increased healthcare access fosters demand, further incentivizing diversified and resilient supplier networks.

Major industry players are investing in capacity expansion, regulatory compliance enhancements, and technological innovations to meet increasing quality standards and global demand.

Key Takeaways

The fenoprofen calcium API landscape is concentrated predominantly in China and India, with European and U.S. quality-focused suppliers also available for high-regulatory markets.
Suppliers must demonstrate compliance with GMP and relevant pharmacopeias, ensuring product safety, efficacy, and regulatory acceptability.
Strategic sourcing involves balancing cost-efficiency with supply chain security, quality assurance, and regulatory requirements.
Due diligence, including audits and certification verification, remains critical in establishing reliable supplier partnerships.
The pharmaceutical market's growth and regulatory evolution demand ongoing assessment of supplier capabilities and capacity.

FAQs

Q1: What are the primary regions supplying fenoprofen calcium API?
A1: China and India dominate fenoprofen calcium API production, with European and U.S. companies providing high-quality options for regulated markets.

Q2: What factors should companies consider when selecting a fenoprofen calcium supplier?
A2: Compliance with GMP, product purity, supply reliability, cost, environmental standards, and regulatory documentation are critical factors.

Q3: Are there any restrictions on sourcing fenoprofen calcium globally?
A3: Sourcing restrictions may arise due to trade sanctions, regional bans, or quality concerns. Regulatory compliance and due diligence mitigate these risks.

Q4: Can fenoprofen calcium be purchased directly from manufacturers?
A4: Yes, companies can purchase APIs directly from established manufacturers or through authorized distributors, provided they meet regulatory and quality standards.

Q5: What is the outlook for the fenoprofen calcium supply chain?
A5: The supply chain is expected to strengthen with capacity expansions, improved manufacturing processes, and diversification of supplier bases to meet increasing global demand.

References

[1] IMS Health Data, 2022. Global NSAID Market Trends.
[2] U.S. FDA Drug Master Files, 2023.
[3] European Pharmacopoeia, 12th Edition, 2021.
[4] Global Active Pharmaceutical Ingredient Market Report, MarketsandMarkets, 2022.
[5] Industry analysis reports on NSAID manufacturing, 2023.

Suppliers and packagers for FENOPROFEN CALCIUM