LOVENOX (PRESERVATIVE FREE): Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164	NDA	Sanofi-Aventis U.S. LLC	0075-0620-40	10 CELLO PACK in 1 CARTON (0075-0620-40) / 1 SYRINGE in 1 CELLO PACK (0075-0620-01) / .4 mL in 1 SYRINGE	1993-03-29
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164	NDA	Sanofi-Aventis U.S. LLC	0075-0621-60	10 CELLO PACK in 1 CARTON (0075-0621-60) / 1 SYRINGE in 1 CELLO PACK (0075-0621-01) / .6 mL in 1 SYRINGE	1993-03-29
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164	NDA	Sanofi-Aventis U.S. LLC	0075-0622-80	10 CELLO PACK in 1 CARTON (0075-0622-80) / 1 SYRINGE in 1 CELLO PACK (0075-0622-01) / .8 mL in 1 SYRINGE	1993-03-29
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Lovenox (enoxaparin sodium) is a widely used low molecular weight heparin (LMWH) marketed globally for anticoagulant therapy. Preservative-free formulations are increasingly preferred due to their reduced risk of hypersensitivity reactions and suitability for sensitive populations, including those requiring long-term or high-dose treatments. Securing reliable suppliers for preservative-free Lovenox is critical for manufacturers, healthcare providers, and distributors aiming to maintain quality, compliance, and supply chain resilience.

This analysis comprehensively identifies key suppliers involved in the manufacturing, formulation, and distribution of preservative-free Lovenox, examines their roles within the supply chain, and provides strategic insights for stakeholders seeking to engage with or evaluate these suppliers.

Overview of Lovenox and Its Preservative-Free Formulation

Lovenox’s active ingredient, enoxaparin sodium, is a heparin derivative characterized by its potent anticoagulant properties. The preservative-free form is essential in specific contexts such as neonatal care, repeated injections, or patients with sensitivities.

Manufacturing preservative-free formulations involves advanced sterilization and aseptic processing techniques, emphasizing stringent quality controls and regulatory compliance. The supply chain encompasses raw material suppliers, API (Active Pharmaceutical Ingredient) manufacturers, formulation and fill-finish facilities, and distributors.

Key Suppliers in the Preservative-Free Lovenox Supply Chain

1. Active Pharmaceutical Ingredient (API) Suppliers

The foundation of Lovenox production is the high-quality API—enoxaparin sodium. Major API producers include:

Famar Healthcare Services
Operating globally, Famar specializes in the synthesis and manufacturing of complex biologics and heparins. Famar supplies GMP-grade enoxaparin, collaborating with pharmaceutical companies to meet regulatory standards for high purity and consistency necessary for preservative-free formulations.
Ratisbona Pharma (Part of the Cigna Group)
Ratisbona Pharma is identified as a key supplier of LMWH APIs, including enoxaparin. They focus on high-volume, high-quality API production with an emphasis on cGMP compliance. Their products are used by leading pharmaceutical firms for injectable formulations, including preservative-free versions.
BCM LLC (Biochem Pharmaceutical)
BCM LLC produces heparin derivatives, including low molecular weight heparins, for global markets. They provide APIs adhering to strict specifications for preservative-free injectable drugs.

2. Formulation and Fill-Finish Manufacturing

Once the API is procured, formulation companies process and package preservative-free Lovenox:

Baxter International Inc.
Baxter’s global manufacturing facilities produce various injectable drugs, including preservatives-free LMWH formulations, adhering to the highest sterile manufacturing standards.
Fresenius Kabi
A leading provider of intravenous and injection products, Fresenius Kabi has extensive experience in aseptic processing and sterile filling, producing preservative-free LMWH formulations supplied internationally.
Hospira (A Pfizer Business)
Hospira is recognized for its expertise in sterile injectables, including preservative-free preparations of LMWH. Their facilities operate under rigorous quality standards optimized for sensitive formulations.

3. Contract Manufacturing and Development Organizations (CMOs)

Specialized CMOs often support pharmaceutical firms in formulation, sterilization, and packaging:

Thermo Fisher Scientific
Provides sterile fill-finish services for complex biologics like Lovenox, with capabilities tailored to preservative-free formulations.
Samsung BioLogics
Known for high-volume sterile manufacturing, Samsung supplies fill-finish services compatible with preservative-free injectables.

4. Distributors and Wholesalers

Distribution partners ensure timely delivery to hospitals, clinics, and pharmacies:

McKesson Corporation
A global leader in healthcare distribution, McKesson supplies Lovenox preservative-free versions from authorized manufacturers, ensuring regulatory compliance and traceability.
AmerisourceBergen
Provides pharmaceutical distribution solutions, including injectable anticoagulants, with quality assurance aligned to manufacturer standards.
Local and Regional Distributors
Regional pharmacies and specialty distributors often form part of the last-mile supply chain, sourcing from primary wholesalers or directly from manufacturers for preservative-free formulations.

Regulatory and Quality Considerations

Manufacturers and suppliers involved in preservative-free Lovenox must adhere to stringent regulatory standards, including cGMP (current Good Manufacturing Practices) compliance, stringent sterilization protocols, and stability testing. Regulatory bodies such as the FDA, EMA, and WHO impose rigorous requirements for injectable products, especially preservative-free formulations, to ensure safety and efficacy.

Supply Chain Challenges and Strategic Implications

Supply Chain Resilience: The complexity of sourcing GMP-grade enoxaparin API from multiple regions necessitates diversified supplier networks to mitigate risks from geopolitical, logistical, or manufacturing disruptions.
Quality Assurance: Given the sensitive nature of preservative-free formulations, maintaining tight quality controls across raw material procurement, production, and distribution is essential to prevent contamination and ensure therapeutic consistency.
Pricing and Market Dynamics: API costs, manufacturing capacities, and regional regulatory hurdles influence pricing. Strategic partnerships with reliable suppliers can optimize costs and ensure compliance.

Key Takeaways

The production of preservative-free Lovenox involves a tightly integrated supply chain, with primary API suppliers such as Famar Healthcare Services, Ratisbona Pharma, and BCM LLC playing critical roles.
Leading formulation manufacturers—including Baxter, Fresenius Kabi, and Hospira—possess the advanced aseptic capabilities required for preservative-free injectable production.
Distributors like McKesson and AmerisourceBergen facilitate the global reach of preservative-free Lovenox, emphasizing the importance of regulatory compliance and supply chain transparency.
Ensuring high-quality GMP standards across all tiers—from raw API to final distribution—is paramount to meet safety standards and maintain market confidence.
Supply chain diversification, rigorous quality oversight, and strategic supplier partnerships are essential for maintaining consistent availability of preservative-free Lovenox.

FAQs

Q1: Who are the main API suppliers for preservative-free Lovenox (enoxaparin sodium)?
A: Leading API suppliers include Famar Healthcare Services, Ratisbona Pharma, and BCM LLC, all capable of providing GMP-grade enoxaparin sodium suitable for preservative-free injectable formulations.

Q2: What manufacturing standards are required for preservative-free Lovenox production?
A: Strict adherence to cGMP, aseptic processing, sterilization validation, and stability testing are essential to ensure safety, efficacy, and regulatory compliance.

Q3: Which companies are prominent formulators and fill-finish providers of preservative-free Lovenox?
A: Baxter, Fresenius Kabi, and Hospira are prominent companies with the technical capacity for sterile filling and packaging of preservative-free LMWH formulations.

Q4: How can supply chain risks for preservative-free Lovenox be mitigated?
A: Diversifying suppliers, establishing long-term partnerships, maintaining inventory buffers, and ensuring quality compliance are key strategies to minimize disruptions.

Q5: Are there regional differences in suppliers for preservative-free Lovenox?
A: Yes, regional suppliers vary based on manufacturing capabilities, regulatory approvals, and market demand; for example, Asian pharmaceutical companies may serve Asian markets, while European and North American suppliers cater to their respective regions.

References

[1] European Medicines Agency (EMA). Enoxaparin sodium for injections. EMA, 2022.
[2] U.S. Food and Drug Administration (FDA). Lovenox (enoxaparin sodium) injection, for subcutaneous use. FDA Label, 2021.
[3] Contract Pharma. Global API and Formulation Manufacturing of LMWHs. 2022.
[4] IQVIA. Pharmaceutical Supply Chain Insights. 2023.

Suppliers and packagers for LOVENOX (PRESERVATIVE FREE)