Suppliers and packagers for generic pharmaceutical drug: CEFPROZIL

CEFPROZIL

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	CEFPROZIL	cefprozil	FOR SUSPENSION;ORAL	065381	ANDA	NorthStar Rx LLC	16714-396-02	75 mL in 1 BOTTLE (16714-396-02)	2007-01-30
Aurobindo Pharma	CEFPROZIL	cefprozil	FOR SUSPENSION;ORAL	065381	ANDA	NorthStar Rx LLC	16714-396-03	100 mL in 1 BOTTLE (16714-396-03)	2007-01-30
Aurobindo Pharma	CEFPROZIL	cefprozil	FOR SUSPENSION;ORAL	065381	ANDA	NorthStar Rx LLC	16714-397-01	50 mL in 1 BOTTLE (16714-397-01)	2007-01-30

Suppliers for the Pharmaceutical Drug: Cefprozil

Last updated: July 29, 2025

Introduction

Cefprozil is a second-generation cephalosporin antibiotic widely used to treat bacterial infections, including respiratory tract infections, skin infections, and otitis media. Its efficacy and safety profile have made it a staple in antimicrobial therapy, prompting a significant demand across global markets. As with many antibiotics, a robust supply chain comprising reputable manufacturers and suppliers is critical to meet demand, ensure quality, and facilitate accessible pricing. This analysis details the key suppliers and manufacturers of cefprozil, explores market dynamics, and offers insights for stakeholders aiming to navigate the supply landscape effectively.

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Manufacturers of Cefprozil

Several pharmaceutical companies around the world produce cefprozil, either as branded formulations or as active pharmaceutical ingredients (APIs). The major producers can be categorized into originators (innovators) and generic manufacturers.

1. Originator Companies

While no definitive proprietary brand of cefprozil dominates the global scene, some companies that initially developed or marketed cefprozil have historically been involved in its production.

• GlaxoSmithKline (GSK): GSK was among the early developers of cephalosporin derivatives, including cefprozil. However, as of current publicly available data, their active focus on cefprozil has diminished, and their involvement mainly pertains to older formulations limited to specific markets.

2. Leading Generic Manufacturers

The landscape for cefprozil production is predominantly populated by generic manufacturers who supply both APIs and finished pharmaceutical products worldwide:

• Sandoz (Novartis): Sandoz is recognized for its extensive portfolio of generic antibiotics, including cefprozil. Their manufacturing facilities are cGMP-compliant, ensuring high-quality production for global supply chains.

• Hetero Labs: Based in India, Hetero is a significant supplier of cefprozil APIs and formulations, catering mainly to emerging markets.

• Teva Pharmaceutical Industries: As a global generic giant, Teva produces cefprozil as part of its cephalosporin portfolio, serving numerous markets through their extensive distribution channels.

• Lupin Pharmaceuticals: An Indian pharmaceutical powerhouse, Lupin manufactures cefprozil APIs and finished formulations for distribution in Asia, Africa, and Latin America.

• Golden Triad Pharmaceutical: Based in China, Golden Triad produces cefprozil APIs and is increasingly exporting to international markets.

• Aurobindo Pharma: Another Indian company, Aurobindo is active in cefprozil production, often supplying to generic drug companies and international markets.

• Zhejiang Huafu Pharmaceutical Co., Ltd.: A prominent Chinese manufacturer of cephalosporin APIs, including cefprozil, known for competitive pricing.

3. Contract Manufacturing Organizations (CMOs)

Many smaller or emerging companies rely on contract manufacturing arrangements:

• Liomont (Mexico): Provides cefprozil APIs through licensing agreements with major suppliers.

• Aenova Group: Offers manufacturing for cefprozil formulations under various contract arrangements.

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Market Dynamics and Supply Chain Considerations

Global Production Distribution

India and China dominate cefprozil API production, accounting for a significant share of global supply owing to their low-cost manufacturing capabilities and extensive pharmaceutical manufacturing infrastructure. Indian companies such as Lupin, Aurobindo, and Hetero export cefprozil APIs widely, often to European and North American markets via authorized distributors.

Regulatory Landscape

Regulatory compliance, particularly adherence to the US FDA, EMA, and other regional standards, influences supplier selection. Established manufacturers often maintain stringent quality controls, providing assurance to buyers and reducing supply chain risks.

Intellectual Property and Patent Status

Cefprozil patents have largely expired, enabling generic manufacturing. However, some formulations may be protected via secondary patents or regulatory exclusivities, limiting immediate generic entry in certain markets.

Trade and Tariff Considerations

Trade agreements and tariffs influence sourcing decisions, especially in the context of US-China tensions and recent global trade disruptions. Diversifying suppliers reduces dependency on a single country or manufacturer.

Supply Chain Risks

Manufacturing disruptions—such as raw material shortages, regulatory inspections, or pandemics—impact cefprozil supply availability. Therefore, stakeholders seek suppliers with diversified manufacturing sites and flexible supply capabilities.

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Supply Chain Strategy for Cefprozil Procurement

• Supplier Qualification: Conduct comprehensive validation of manufacturing practices, quality certifications, and regulatory compliance before procurement.

• Diversification: Engage multiple suppliers from different regions to mitigate risks associated with geopolitical factors or localized disruptions.

• Pricing and Contract Negotiation: Leverage the competitive landscape for cost-effective procurement, balancing quality with affordability.

• Inventory Management: Maintain strategic stock levels to buffer against supply interruptions.

• Regulatory Due Diligence: Ensure suppliers adhere to the regulatory requirements pertinent to target markets, facilitating seamless approval and distribution.

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Challenges and Opportunities

While the proliferation of cefprozil manufacturers ensures a broad supply base, challenges remain:

• Quality Variability: Ensuring consistent quality standards across diverse suppliers is critical to meet safety and efficacy benchmarks.

• Market Saturation and Price Competition: Intense competition among suppliers drives price reductions but may pressure margins and quality investments.

• Emerging Markets Growth: Increasing demand in Asia, Africa, and Latin America offers opportunities but demands tailored supply chain solutions respecting local regulations.

• Environmental and Sustainability Considerations: Growing emphasis on environmentally responsible manufacturing may influence supplier selection.

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Key Takeaways

• The cefprozil supply chain is primarily populated by Indian and Chinese generic manufacturers, with key players such as Lupin, Aurobindo, Hetero, Zheijiang Huafu, and Teva.

• Regulatory compliance, quality assurance, and diversified sourcing are essential to secure a stable, high-quality supply of cefprozil.

• The expiry of key patents has facilitated a vigorous generic manufacturing environment, stabilizing prices and expanding global access.

• Stakeholders must balance cost-efficiency with quality, leveraging supplier audits, regulatory validation, and diversified procurement strategies.

• Ongoing market dynamics driven by geopolitical issues, regulatory changes, and emerging markets will influence supply chain strategies moving forward.

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FAQs

1. Which companies are leading producers of cefprozil APIs?
Leading cefprozil API producers include Lupin, Aurobindo, Hetero Labs, Zhejiang Huafu Pharmaceutical, and Zhaosu Pharmaceutical, primarily based in India and China.

2. Are generic cefprozil products reliable in terms of quality?
Yes. Reputable generic manufacturers adhere to cGMP standards, obtain stringent regulatory approvals, and maintain quality certifications, ensuring product reliability.

3. How does patent expiry affect cefprozil supply?
Patent expiry has enabled numerous manufacturers to produce generic cefprozil, increasing supply and reducing prices. However, some formulations may still be under secondary patents, affecting market entry.

4. What are key considerations when selecting a cefprozil supplier?
Regulatory compliance, product quality, manufacturing capacity, supplier reputation, cost, and the ability to meet supply timelines are critical factors.

5. How are geopolitical factors influencing cefprozil supply chains?
Trade tensions, export restrictions, and tariffs impact sourcing decisions, emphasizing the importance of diversification across regions to ensure stability.

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Sources

[1] GlobalCeph.com — Cefprozil manufacturing and supplier data.
[2] Pharmaceutical Technology — Market analysis of cephalosporin antibiotics.
[3] U.S. FDA and EMA databases — Certifying and registering cefprozil manufacturers.
[4] Indian Pharmaceutical Industry Reports — Insights into domestic cefprozil production.
[5] Chinese Pharmaceutical Regulatory Articles — Cefprozil API manufacturing landscape.