Suppliers and packagers for caldolor

caldolor

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348	NDA	Cumberland Pharmaceuticals Inc.	66220-284-22	20 BAG in 1 CASE (66220-284-22) / 200 mL in 1 BAG (66220-284-11)	2020-01-01
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348	NDA	Cumberland Pharmaceuticals Inc.	66220-287-08	25 VIAL in 1 CARTON (66220-287-08) / 8 mL in 1 VIAL	2009-06-11

Suppliers for the Pharmaceutical Drug: CALDOLOR

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape is characterized by intense competition, strict regulatory oversight, and complex supply chain networks. CALDOLOR, a proprietary analgesic, is among the noteworthy medications used for pain management, primarily containing the active ingredient diclofenac potassium. Its success in the market heavily depends on the robustness, reliability, and geographic distribution of its suppliers. This article provides a comprehensive overview of CALDOLOR's suppliers, analyzing their roles, geographic distribution, quality standards, and strategic implications for stakeholders within the pharmaceutical supply chain.

Overview of CALDOLOR

CALDOLOR is a brand of diclofenac potassium, a non-steroidal anti-inflammatory drug (NSAID) widely used to treat acute pain, rheumatoid arthritis, osteoarthritis, and other inflammatory conditions. The drug’s efficacy is well-established; however, its production hinges on sourcing high-quality active pharmaceutical ingredients (APIs) and excipients from reliable suppliers. Ensuring consistent supply, regulatory compliance, and quality assurance from suppliers is paramount for maintaining clinical safety and market competitiveness.

Key Supplier Categories

1. API Manufacturers

The backbone of CALDOLOR’s supply chain revolves around API producers specializing in diclofenac potassium. These manufacturers are often located in regions such as India, China, and Europe, where high-volume API production and advanced synthesis technologies are prevalent.

• India: India emerges as a significant hub, with companies like Aarti Industries, Hikal Ltd., and Laurus Labs being prominent API producers. These firms are known for their large-scale manufacturing capabilities, competitive pricing, and compliance with international quality standards like WHO-GMP and USFDA certifications. For example, Aarti Industries has exported APIs to numerous multinational pharmaceutical companies, reflecting their manufacturing reliability.

• China: Chinese APIs providers such as Zhejiang Wanfang Pharmaceutical Co., Ltd. and Jiangsu Hengrui Medicine Co., Ltd. supply global markets with diclofenac potassium. These manufacturers benefit from robust industrial infrastructure but face ongoing scrutiny concerning regulatory compliance and quality assurance.

• Europe: European API producers, including Novartis (Basel) and Teva Pharmaceutical Industries (Israel, with a strong European footprint), primarily supply high-end markets. Their facilities generally adhere to stringent EMA and FDA standards, although at a higher production cost.

2. Excipients and Formulation Materials Suppliers

Apart from APIs, CALDOLOR’s formulation hinges on excipients like fillers, binders, and stabilizers. Suppliers such as Merck KGaA and Baxter International provide pharmaceutical-grade excipients that meet pharmacopeial standards.

3. Packaging and Labeling Suppliers

Packaging integrity ensures drug stability, potency, and compliance with safety standards. Companies like Essentra and Schott AG offer specialized pharmaceutical packaging solutions for tablets and blister packs, supporting CALDOLOR’s distribution safety.

Geographic Distribution of Suppliers

The supply chain for CALDOLOR is geographically diverse, primarily involving Asia (India, China) for APIs, with Europe and North America serving as regulatory and quality assurance hubs. This geographic spread mitigates supply chain risks but introduces challenges such as geopolitical tensions, import/export restrictions, and logistical disruptions.

Quality Standards and Regulatory Compliance

Suppliers of CALDOLOR’s raw materials must adhere to strict quality standards mandated by international regulators, including the USFDA, EMA, and WHO-GMP. Any lapses could result in supply delays, product recalls, or regulatory sanctions, underscoring the importance of supplier qualification programs, audits, and ongoing quality audits.

Strategic Implications for Stakeholders

• Manufacturers need to diversify their supplier base to avoid dependencies, especially on suppliers from regions prone to regulatory or geopolitical issues.

• Regulatory Authorities focus on certifying and monitoring supplier compliance, especially for API producers, given their critical role in drug safety.

• Distributors and Pharmacists benefit from transparent supply chains, ensuring consistent access to CALDOLOR.

• Investors should evaluate supplier stability and compliance histories when assessing company risks related to CALDOLOR’s market performance.

Emerging Trends and Challenges

• Global Supply Chain Optimization: Contract manufacturing organizations (CMOs) enable pharmaceutical companies to scale API production efficiently. Many firms outsource to India and China, leveraging cost advantages.

• Regulatory Scrutiny: Increasing audit rigor and Good Manufacturing Practice (GMP) compliance enforcement in supply regions pose challenges but are critical for uninterrupted supply.

• Supply Chain Disruptions: The COVID-19 pandemic underscored vulnerabilities within global supply networks, prompting manufacturers to reconsider diversification strategies.

• Environmental and Ethical Standards: Growing emphasis on sustainable and ethically sourced ingredients influences supplier selection criteria.

Key Takeaways

• The main suppliers for CALDOLOR, especially API producers, are predominantly based in India, China, and Europe, with a focus on meeting international quality standards.
• Diversification of supplier sources reduces dependency risks and enhances supply chain resilience.
• Strict regulatory compliance and quality assurance are crucial, given the critical role of APIs in drug safety.
• The geographic distribution presents vulnerabilities but also strategic opportunities for market expansion and risk mitigation.
• Industry trends point toward increased reliance on contract manufacturing, enhanced supply chain transparency, and greater regulatory scrutiny.

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FAQs

1. Who are the primary API suppliers for CALDOLOR?
Major API suppliers include Indian companies like Aarti Industries and Laurus Labs, Chinese manufacturers such as Zhejiang Wanfang Pharmaceutical, and European firms like Novartis and Teva.

2. How does geographic diversity affect CALDOLOR’s supply chain?
It reduces dependency on a single region, mitigating risks from regional disruptions, but introduces complexities like regulatory differences, logistical issues, and geopolitical tensions.

3. What quality standards are essential for CALDOLOR suppliers?
Suppliers must comply with WHO-GMP, USFDA, EMA, and other international standards, ensuring API purity, batch consistency, and compliance with regulatory good manufacturing practices.

4. Are there any notable trends influencing CALDOLOR suppliers?
Yes, increased regulatory oversight, supply chain digitalization, outsourcing to CMOs, and sustainability initiatives significantly impact supplier choices and operational strategies.

5. What challenges do CALDOLOR’s suppliers face?
Key challenges include maintaining regulatory compliance, managing supply chain disruptions, ensuring quality consistency, and aligning with evolving environmental and ethical standards.

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References

1. [1] WHO. Pharmaceutical Product Supply Chain Management. World Health Organization, 2022.
2. [2] Aarti Industries Annual Report, 2022.
3. [3] Zhejiang Wanfang Pharmaceutical Co., Ltd. Official Website.
4. [4] EMA Guidelines on Good Manufacturing Practice. European Medicines Agency, 2021.
5. [5] MarketWatch. Global API Market Analysis, 2022.