Suppliers and packagers for generic pharmaceutical drug: DICLOXACILLIN SODIUM

DICLOXACILLIN SODIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	DICLOXACILLIN SODIUM	dicloxacillin sodium	CAPSULE;ORAL	216845	ANDA	Aurobindo Pharma Limited	59651-565-01	100 CAPSULE in 1 BOTTLE (59651-565-01)	2022-09-23
Aurobindo Pharma	DICLOXACILLIN SODIUM	dicloxacillin sodium	CAPSULE;ORAL	216845	ANDA	Aurobindo Pharma Limited	59651-566-01	100 CAPSULE in 1 BOTTLE (59651-566-01)	2022-09-23
Teva	DICLOXACILLIN SODIUM	dicloxacillin sodium	CAPSULE;ORAL	062286	ANDA	Teva Pharmaceuticals USA, Inc.	0093-3123-01	100 CAPSULE in 1 BOTTLE (0093-3123-01)	1990-09-30
Teva	DICLOXACILLIN SODIUM	dicloxacillin sodium	CAPSULE;ORAL	062286	ANDA	Teva Pharmaceuticals USA, Inc.	0093-3125-01	100 CAPSULE in 1 BOTTLE (0093-3125-01)	1990-09-30

Suppliers for the Pharmaceutical Drug: DICLOXACILLIN SODIUM

Last updated: July 29, 2025

Introduction

Dicloxacillin sodium is a semisynthetic penicillin antibiotic used primarily to treat susceptible bacterial infections, especially those caused by penicillinase-producing staphylococci. As a critical antimicrobial agent, reliable and compliant suppliers are vital for pharmaceutical companies, healthcare providers, and governments to ensure drug availability, quality, and affordability. This report provides a comprehensive analysis of key suppliers manufacturing dicloxacillin sodium, discussing their global presence, regulatory status, manufacturing capabilities, and strategic significance.

Global Manufacturing Landscape

The supply chain for dicloxacillin sodium is characterized by a limited number of specialized pharmaceutical manufacturers primarily operating in China, India, and certain European countries. The complex synthesis process, strict regulatory compliance, and quality assurance routines narrow the pool of suppliers capable of producing pharmaceutical-grade dicloxacillin sodium. Consequently, these suppliers primarily serve generic manufacturers, research institutions, and pharmaceutical conglomerates seeking high-quality antibiotics.

Major Regional Suppliers

• China: Chinese manufacturers dominate the production of dicloxacillin sodium due to their extensive generic drug manufacturing infrastructure. Companies such as Shandong Qilu Pharmaceutical, Hainan Haiya Pharmaceutical, and Jiangsu Hengrui Medicine possess the requisite Good Manufacturing Practice (GMP) certifications. These firms are often involved in bulk active pharmaceutical ingredient (API) exports aligned with WHO compliance standards.

• India: Indian API manufacturers such as Aurobindo Pharma, Sun Pharmaceutical Industries, and Lupin Ltd. manufacture dicloxacillin sodium at large scales, adhering to stringent international regulatory standards. India's active API export market is driven by cost advantages and robust quality control measures.

• Europe: While European suppliers are fewer, companies like Evonik Industries (formerly part of Degussa) have historically produced high-purity APIs, including dicloxacillin sodium, mainly for research and specialized pharmaceutical needs. The European market's focus lies in high-quality, regulatory-compliant production.

Key Suppliers and Their Capabilities

1. Shandong Qilu Pharmaceutical (China)

• Overview: A leading Chinese pharmaceutical company specializing in antibiotics and anti-infectives.
• Capabilities: Extensive production facilities for API synthesis, with ISO 9001 and GMP certifications.
• Regulatory Standing: Approved by the Chinese National Medical Products Administration (NMPA); export licenses to the US, EU, and developing markets.
• Supply Volume: Capable of large-scale exports supporting generics and branded formulations.

2. Aurobindo Pharma (India)

• Overview: One of India's top API manufacturers, with significant share in antibiotics production.
• Capabilities: Advanced synthesis processes, ensuring high purity APIs conforming to international standards.
• Regulatory Standing: US FDA-approved facilities, EUGMP certifications, and WHO prequalification.
• Supply Volume: Supplies multinational pharmaceutical companies with active ingredients, including dicloxacillin sodium.

3. Lupin Ltd. (India)

• Overview: Recognized for its global API manufacturing footprint.
• Capabilities: Robust R&D and manufacturing infrastructure for penicillin derivatives.
• Regulatory Standing: UK MHRA and US FDA-approved manufacturing plants.
• Supply Volume: Provides APIs to generic and branded drug manufacturers worldwide.

4. Evonik Industries (Europe / Global)

• Overview: Specializes in specialty chemicals with a history of pharmaceutical API production.
• Capabilities: High-quality APIs for research and niche applications.
• Regulatory Standing: Approved by European and US authorities; strong focus on compliance.
• Supply Volume: Smaller scale but critical for high-purity requirements.

5. Local and Regional Suppliers

In addition to major global players, several local vendors in markets like Southeast Asia, Latin America, and Africa supply dicloxacillin sodium, often under licensing agreements or OEM contracts.

Regulatory and Quality Considerations

Suppliers must meet international quality standards—specifically, GMP, WHO prequalification, and country-specific regulatory requirements (e.g., FDA, EMA, NMPA). For procurement purposes, verifying supplier certifications, audit histories, and compliance documentation is essential. The criticality of the active pharmaceutical ingredient (API) quality for efficacy and safety mandates rigorous supplier qualification processes.

Supply Chain Challenges and Opportunities

• Supply Chain Disruptions: Current geopolitical tensions, COVID-19-related disruptions, and logistical constraints challenge the steady supply of dicloxacillin sodium.
• Generic Market Dynamics: Patent expirations and regulatory approvals expand the roster of suppliers, improving affordability and access.
• Quality Assurance: Increasing regulatory scrutiny emphasizes supplier transparency, further pushing manufacturers toward certified, compliant fournisseur bases.
• Strategic Inventory: Companies often maintain multiple suppliers to mitigate risk and ensure continuous supply.

Emerging Trends

• Vertical Integration: Larger pharmaceutical firms are investing in API manufacturing capacity or acquiring existing API facilities for supply security.
• Sustainable Production: Emphasis on environmentally sustainable processes influences supplier selection.
• Regulatory Harmonization: Increased alignment of international standards simplifies cross-border supplier qualification.

Conclusion

The global landscape for dicloxacillin sodium suppliers is dominated by robust Chinese and Indian manufacturers with extensive GMP compliance and export experience. European suppliers, though fewer, tend to focus on high-purity niche APIs for specialized markets. As demand persists and regulatory standards stiffen, pharmaceutical companies should prioritize proven, certified suppliers with scalable manufacturing capacities. Diversification, diligent qualification, and ongoing monitoring remain essential to maintaining a reliable dicloxacillin sodium supply chain.

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Key Takeaways

• Dominant Suppliers: Chinese and Indian manufacturers are primary sources of dicloxacillin sodium, offering scalability and cost advantages.
• Quality & Compliance: Strict adherence to GMP and international standards is non-negotiable for supplier qualification.
• Supply Chain Resilience: Diversification among reputable suppliers mitigates risks related to geopolitical and logistical disruptions.
• Emerging Trends: Increasing focus on sustainability and regulatory alignment influences supplier selection.
• Strategic Procurement: Establishing long-term relationships with multiple certified suppliers enhances supply security and regulatory compliance.

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FAQs

1. What are the primary regions producing dicloxacillin sodium?
China and India are the leading regions, hosting most of the global production capacity for dicloxacillin sodium, primarily through large-scale API manufacturers.

2. How important are regulatory certifications when selecting a supplier?
Regulatory certifications such as GMP, WHO prequalification, and approvals from agencies like the FDA or EMA are critical indicators of quality, safety, and compliance, especially for pharmaceutical APIs.

3. Can new suppliers enter the dicloxacillin sodium market easily?
Entry is challenging due to complex synthesis processes, strict quality standards, and regulatory barriers. Only experienced, certified manufacturers with proven GMP compliance can reliably produce pharmaceutical-grade dicloxacillin sodium at scale.

4. What risks are associated with dependency on a limited supplier base?
Dependence on few suppliers exposes companies to supply disruptions, quality issues, and regulatory delays. Diversifying suppliers mitigates these risks.

5. Are there sustainable or environmentally friendly manufacturing options for dicloxacillin sodium?
While emerging, sustainable manufacturing practices are increasingly prioritized; however, the complexity of antibiotic synthesis poses challenges, and not all suppliers currently implement green chemistry principles.

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References:
[1] World Health Organization. (2022). WHO List of Prequalified Medicinal Products.
[2] U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
[3] European Medicines Agency. (2022). Certification and Authorization Data.
[4] Industry Reports and Supplier Websites (e.g., Aurobindo, Lupin, Shandong Qilu).