cefadroxil/cefadroxil hemihydrate: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	CEFADROXIL	cefadroxil/cefadroxil hemihydrate	CAPSULE;ORAL	065352	ANDA	NorthStar Rx LLC	16714-388-01	50 CAPSULE in 1 BOTTLE (16714-388-01)	2007-01-25
Aurobindo Pharma	CEFADROXIL	cefadroxil/cefadroxil hemihydrate	CAPSULE;ORAL	065352	ANDA	NorthStar Rx LLC	16714-388-02	100 CAPSULE in 1 BOTTLE (16714-388-02)	2007-01-25
Aurobindo Pharma	CEFADROXIL	cefadroxil/cefadroxil hemihydrate	CAPSULE;ORAL	065352	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-595-20	20 CAPSULE in 1 BOTTLE, PLASTIC (43063-595-20)	2007-01-25
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 11, 2025

Introduction

Cefadroxil, a broad-spectrum cephalosporin antibiotic, is used primarily to treat bacterial infections, including urinary tract infections, skin infections, and pharyngitis. Its hemihydrate form enhances stability and solubility, facilitating pharmaceutical manufacturing processes. As demand for cefadroxil grows globally, a robust supply chain comprising reliable suppliers becomes essential for pharmaceutical companies, contract manufacturing organizations (CMOs), and generic drug producers. This article provides a comprehensive overview of key suppliers providing cefadroxil and cefadroxil hemihydrate, highlighting their manufacturing capabilities, geographic distribution, and market impact.

Global Manufacturing Landscape

The supply of cefadroxil and its hemihydrate variant originates predominantly from established chemical and pharmaceutical manufacturers across Asia, Europe, and North America. Asia, particularly India and China, dominates the production due to cost efficiencies and large-scale chemical manufacturing expertise. European and North American suppliers focus on high-quality standards, strong regulatory compliance, and supply chain reliability.

Major Suppliers of Cefadroxil and Cefadroxil Hemihydrate

1. Cadila Healthcare Ltd. (India)

Cadila Healthcare, headquartered in Ahmedabad, India, is a prominent player in the antibiotics manufacturing domain. The company produces cefadroxil as part of its broad-spectrum antibiotic portfolio, often supplying both the Active Pharmaceutical Ingredient (API) and finished formulations. Their facilities are WHO-GMP and PIC/S compliant, ensuring quality for export markets.

Capabilities:

Large-scale cefadroxil API production with high purity standards.
Supply of cefadroxil hemihydrate with consistent quality control measures.
Global distribution network, particularly serving African, Middle Eastern, and Asian markets.

Market Impact:
Cadila's robust manufacturing infrastructure positions it as a key supplier in developing economies, supporting generic drug manufacturers worldwide.

2. Jiangxi Zhenkang Pharmaceutical Co., Ltd. (China)

Jiangxi Zhenkang Pharmaceutical specializes in the synthesis of cephalosporin APIs, including cefadroxil hemihydrate. Their extraction and synthesis processes adhere to strict quality standards, which helps their products meet rigorous regulatory requirements.

Capabilities:

Custom synthesis of cefadroxil hemihydrate for bulk supply.
Certifications include ISO 9001 and GMP compliance.
Competitive pricing facilitating global access.

Market Impact:
This supplier taps into the growing Chinese pharmaceuticals export sector, providing affordable cefadroxil variants to emerging markets.

3. Alkem Laboratories Ltd. (India)

Alkem Laboratories is among India’s leading pharmaceutical companies with a significant presence in antibiotics manufacturing. The company produces cefadroxil API and supplies cefadroxil hemihydrate, primarily targeting Indian and international markets.

Capabilities:

In-house scale-up from lab to commercial manufacturing.
Strict adherence to cGMP regulations.
Dedicated R&D for API development to improve yields and purity.

Market Impact:
Alkem’s extensive distribution network ensures widespread availability, supporting both domestic needs and export commitments.

4. Sandoz (Novartis Group) (Switzerland/Global)

Sandoz, a division of Novartis, focuses on generic pharmaceuticals, including antibiotics like cefadroxil. While primarily distributing finished formulations, they also engage in the production and supply of API, including cefadroxil hemihydrate, depending on customer demand.

Capabilities:

High-quality manufacturing compliant with global standards.
Focus on supply chain integrity and regulatory compliance.
Strong presence in North America and Europe.

Market Impact:
Sandoz’s reputation for quality and regulatory adherence makes it a preferred supplier for partnerships requiring assured product integrity.

5. Aurobindo Pharma Ltd. (India)

Aurobindo Pharma is a major Indian API manufacturer and finished drug producer. The company supplies cefadroxil as API and has capacity to produce cefadroxil hemihydrate conforming to international standards.

Capabilities:

Large API manufacturing capacity for cephalosporins.
Robust quality assurance protocols.
Extensive export network catering to regulated and semi-regulated markets.

Market Impact:
Aurobindo’s strategic focus on cost-effective production enables it to serve as a key supplier for generic cefadroxil formulations globally.

Regulatory and Quality Standards

Suppliers operating in this sector must adhere to stringent regulatory standards, including Good Manufacturing Practices (GMP), ISO certifications, and compliance with local regulatory authorities like the US FDA, EMA, TGA, and other agencies. These standards ensure the safety, efficacy, and quality consistency of cefadroxil and cefadroxil hemihydrate, influencing supplier selection particularly for markets with high regulatory barriers.

Market Dynamics and Challenges

Supply Chain Security: The recent global disruptions—material shortages, geopolitical tensions, and logistics constraints—have underscored the importance of diversified supplier bases.
Quality Variability: While many Asian manufacturers offer cost-effective APIs, quality assurance remains critical, especially for markets with stringent regulatory requirements.
Intellectual Property (IP): Although cefadroxil is off-patent, licensing agreements and regulatory permissions influence sourcing strategies.
Environmental and Ethical Regulations: Increasing environmental standards necessitate sustainable manufacturing practices, influencing supplier choice.

Emerging Suppliers and Future Trends

Emerging manufacturers in Southeast Asia and Eastern Europe are entering the cefadroxil supply chain, driven by rising demand and efforts to diversify geographic reliance. Additionally, vertical integration trends—manufacturers controlling both API synthesis and formulation—may influence market competition.

The adoption of continuous manufacturing processes and process innovations enhances production efficiencies and quality, benefitting future supply stability. Investment in quality systems and regulatory compliance remains a priority for suppliers seeking global market access.

Conclusion

The supply chain for cefadroxil and its hemihydrate form includes established players predominantly in India, China, and Europe. Leading firms like Cadila, Alkem, Jiangxi Zhenkang, Aurobindo, and Sandoz form the backbone of global supply, each with strengths in manufacturing capacity, regulatory compliance, and market reach. As demand persists and evolves, diversification of suppliers and reinforcement of quality standards will be critical for pharmaceutical companies relying on cefadroxil.

Key Takeaways

Diverse Supplier Base: Indian and Chinese manufacturers dominate, supported by European players like Sandoz. Diversification mitigates supply risks.
Regulatory Compliance: Ensuring supplier adherence to GMP and international standards is vital for market access, especially in regulated markets.
Sustainable Supply Chain: Geopolitical and logistical uncertainties highlight the need for strategic sourcing and safety stocks.
Quality Assurance: Prioritize suppliers with proven quality records and certifications to prevent regulatory setbacks.
Emerging Markets: New suppliers in Southeast Asia and Eastern Europe are poised to expand the availability of cefadroxil APIs, fostering competitive pricing and innovation.

FAQs

1. What are the primary regions producing cefadroxil and cefadroxil hemihydrate?
India and China lead manufacturing due to cost advantages and manufacturing scale, while Europe and North America focus on high-quality production and regulatory compliance.

2. How does the hemihydrate form of cefadroxil differ from the anhydrous form?
Cefadroxil hemihydrate contains water molecules within its crystalline structure, enhancing stability and solubility, which benefits formulation and storage.

3. What are the key factors to consider when selecting a cefadroxil supplier?
Regulatory compliance, production capacity, quality standards (GMP certifications), reliable supply history, and cost competitiveness.

4. Are there any notable regulatory challenges in sourcing cefadroxil APIs?
Yes; dealing with suppliers lacking GMP certification or strict quality controls can result in regulatory rejections or market access barriers, especially in highly regulated markets like the US and EU.

5. What future trends could impact the cefadroxil supply chain?
Increased use of continuous manufacturing, sustainable production practices, supplier diversification, and shifts in regulatory environments will shape future supply stability.

Sources:

[1] Pharmaceutical Technology, "Global Cephalosporin API Market Analysis," 2022.
[2] WHO Prequalified Pharmaceutical Manufacturers List, 2023.
[3] Indian Pharmaceutical Industry Reports, 2022.
[4] European Medicines Agency (EMA) Guidelines on API Manufacturing, 2023.
[5] MarketWatch, "API Price Trends Post-Pandemic," 2023.

Suppliers and packagers for generic pharmaceutical drug: cefadroxil/cefadroxil hemihydrate