Suppliers and packagers for CEFOTAXIME

CEFOTAXIME

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	CEFOTAXIME	cefotaxime sodium	INJECTABLE;INJECTION	065072	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9930-10	10 VIAL in 1 PACKAGE (0143-9930-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9930-01)	2002-11-20
Hikma	CEFOTAXIME	cefotaxime sodium	INJECTABLE;INJECTION	065072	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9931-25	25 VIAL in 1 PACKAGE (0143-9931-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9931-01)	2002-11-20
Hikma	CEFOTAXIME	cefotaxime sodium	INJECTABLE;INJECTION	065072	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9933-25	25 VIAL in 1 PACKAGE (0143-9933-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9933-01)	2002-11-20

Suppliers for the Pharmaceutical Drug: CEFOTAXIME

Last updated: July 27, 2025

Introduction

Cefotaxime is a third-generation cephalosporin antibiotic widely used for treating severe bacterial infections, including pneumonia, meningitis, and urinary tract infections. Its effectiveness hinges on the quality and reliability of its suppliers, making the sourcing landscape a vital aspect for pharmaceutical companies, healthcare providers, and distributors. This article presents a comprehensive overview of key suppliers of cefotaxime, exploring global manufacturing dynamics, regulatory considerations, and market trends.

Global Manufacturing Landscape

Leading Countries in Cefotaxime Production

The production of cefotaxime primarily occurs in regions with established pharmaceutical manufacturing capabilities, notably in India, China, and Europe.

• India: India is among the major producers, leveraging its robust generic pharmaceutical industry. Companies such as Intas Pharmaceuticals and Dr. Reddy’s Laboratories manufacture cefotaxime, benefiting from cost advantages and a large export market. These firms often produce both active pharmaceutical ingredients (APIs) and finished formulations.

• China: Chinese manufacturers like Qilu Pharmaceutical and Huangshan Sanchuang Pharmaceutical Co. also supply cefotaxime, especially the API. China's expanding pharmaceutical sector and supportive government policies foster increased production capacities.

• Europe: European firms, such as Sandoz (a Novartis division) and Fresenius Kabi, supply high-quality cefotaxime APIs and finished products, emphasizing stringent regulatory compliance and manufacturing standards (e.g., cGMP).

Major API Suppliers

The core of cefotaxime procurement is sourcing high-quality APIs. Several vendors are recognized for this:

• Hetero Labs Ltd. (India): A prominent supplier known for a comprehensive portfolio of cephalosporins, including cefotaxime API, with consistent regulatory compliance (FDA, EMA, DCGI approvals).

• Alkem Laboratories (India): Offers cefotaxime API with a focus on quality control and global packaging standards.

• Lupin Limited (India): Known for manufacturing cefotaxime API as part of its broad cephalosporin range, with WHO-GMP assessed facilities.

• Qilu Pharmaceutical (China): Provides API for domestic and international markets, emphasizing low-cost production and scale.

• Huangshan Sanchuang Pharmaceutical (China): Supplies cefotaxime API, often catering to price-sensitive markets.

Finished Dosage Form Suppliers

Manufacturers of cefotaxime finished formulations also form a crucial part of the supply chain:

• Sandoz (Novartis): Offers cefotaxime injections globally, adhering to high manufacturing standards.

• Fresenius Kabi: Supplies cefotaxime injectable formulations, emphasizing quality and delivery consistency.

• Hospira (now part of Pfizer): Historically a supplier of cefotaxime via injectables, with a focus on hospital markets.

Regulatory and Quality Considerations

Given the critical nature of antibiotics, regulatory compliance is a key criterion for suppliers. Leading suppliers typically meet standards from authorities like:

• U.S. Food and Drug Administration (FDA): Ensures API and finished product quality through rigorous inspections.

• European Medicines Agency (EMA): Sets high standards for manufacturing practices within the EU.

• China Food and Drug Administration (CFDA)/NMPA: Chinese API suppliers adhere to evolving quality standards, with some now obtaining GMP certification recognized internationally.

• Indian Pharmacopoeia Standards: Indian suppliers often conform to the Indian Pharmacopoeia, with many achieving certifications from global regulators.

Sourcing from suppliers with multiple regulatory approvals reduces supply chain risks and ensures compliance with international standards.

Market Trends and Challenges

Increasing Demand for Generics

The global demand for affordable antibiotics like cefotaxime, especially in emerging markets, fuels supply growth. Indian and Chinese API manufacturers benefit from cost advantages, enabling competitive pricing.

Supply Chain Risks

Disruptions due to geopolitical tensions, regulatory changes, or manufacturing issues can impact cefotaxime supply. Recent curbs on certain Chinese and Indian APIs highlight the necessity for diversified sourcing.

Quality Assurance and Counterfeiting

Counterfeit antibiotics pose health risks and threaten brand reputation. Manufacturers investing in robust quality control, serialization, and track-and-trace systems mitigate these risks.

Regulatory Harmonization

International efforts aim to harmonize quality standards. Suppliers that maintain compliance with global GMP standards gain a competitive edge.

Key Players Summary

Supplier	Country	Focus	Regulatory Approvals	Notes
Hetero Labs	India	API and formulations	FDA, EMA, WHO-GMP	Recognized for consistent quality
Alkem Laboratories	India	API	GMP, USFDA, EU approvals	Large export footprint
Lupin Limited	India	API and formulations	Regulatory compliant	Diversified product portfolio
Qilu Pharmaceutical	China	API	CFDA/NMPA certifies	Cost-effective API supply
Huangshan Sanchuang Pharmaceutical	China	API	GMP standards	Price-sensitive markets
Sandoz (Novartis)	Switzerland/Global	Finished dosage forms	Multiple global approvals	Focus on high-quality injectable formulations
Fresenius Kabi	Germany	Injectable solutions	cGMP compliant	Emphasizes safety and supply reliability

Conclusion

The cefotaxime supply chain encompasses a diverse set of suppliers primarily from India, China, and Europe, each offering varying advantages in terms of cost, quality, and regulatory compliance. Strategic sourcing from well-regarded, GMP-certified manufacturers is critical to ensure supply continuity, product efficacy, and regulatory adherence. As market dynamics evolve, diversification and rigorous quality assurance will remain essential for stakeholders seeking reliable cefotaxime sources.

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Key Takeaways

• Diversify sourcing: Relying on multiple suppliers across regions mitigates risks associated with geopolitical, regulatory, or supply disruptions.

• Prioritize quality and compliance: Engaging suppliers with international regulatory approvals ensures product safety and broad market acceptance.

• Monitor market trends: Increasing demand for affordable generics highlights opportunities for suppliers and buyers, but also necessitates vigilance regarding quality standards.

• Regulatory landscape awareness: Staying abreast of evolving standards and certifications is vital for maintaining supply chain integrity.

• Invest in transparency and traceability: Leveraging serialization and track-and-trace systems reduces counterfeit risks, safeguarding patient health and brand reputation.

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FAQs

1. Who are the top API suppliers for cefotaxime?
   Major API suppliers include Hetero Labs, Alkem Laboratories, Lupin Limited (India), Qilu Pharmaceutical, and Huangshan Sanchuang Pharmaceutical (China).

2. Which manufacturers produce cefotaxime in finished dosage forms?
   Notable finished form suppliers include Sandoz (Novartis), Fresenius Kabi, and Hospira (Pfizer).

3. What are the key regulatory considerations when sourcing cefotaxime?
   Suppliers must comply with cGMP standards and hold approvals from authorities such as the FDA, EMA, and respective national agencies like NMPA or CDSCO.

4. How do geopolitical factors affect cefotaxime supply?
   Tensions can impact factory operations, export policies, or regulatory environments, emphasizing the need for diversified sourcing.

5. What trends are shaping the cefotaxime supply chain?
   Growing demand for affordable generics, increasing regulatory scrutiny, and efforts to strengthen supply chain resilience are prominent trends.

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References:

[1] World Health Organization. (2022). Antibiotics: Role and Supply Chain.
[2] U.S. FDA Drug Master Files. (2023). List of approved cephalosporin APIs.
[3] Indian Pharmacopoeia Commission. (2021). Standards for Cefotaxime.
[4] Chinese NMPA. (2022). API GMP certification guidelines.
[5] Market Intelligence Reports. (2023). Global Cefotaxime Market Analysis.