MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Labs Ltd	MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	moxifloxacin hydrochloride	SOLUTION;INTRAVENOUS	205833	ANDA	Mylan Institutional LLC	67457-323-25	1 BAG in 1 CARTON (67457-323-25) / 250 mL in 1 BAG	2017-10-03
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 1, 2025

Introduction

Moxifloxacin hydrochloride, a broad-spectrum fluoroquinolone antibiotic, is widely used in ophthalmic and injectable formulations to treat bacterial infections. The specific formulation—moxifloxacin hydrochloride in sodium chloride 0.8% administered via plastic containers—is a critical product for healthcare providers globally. Securing reliable suppliers is essential for pharmaceutical companies, hospital procurement departments, and distribution channels to ensure consistent supply, regulatory compliance, and quality assurance.

Market Overview

The production of moxifloxacin hydrochloride in aqueous solutions involves advanced chemical synthesis, stringent quality controls, and adherence to Good Manufacturing Practices (GMP). The formulation in sodium chloride 0.8% enhances isotonicity, making it suitable for intravenous or ophthalmic administration. Plastic container packaging offers benefits such as reduced breakage risk, ease of handling, and cost efficiency.

Major suppliers span across leading pharmaceutical ingredient manufacturers and contract manufacturing organizations (CMOs). Globally, they operate within tight regulatory frameworks, including approvals from agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others.

Key Suppliers of Moxifloxacin Hydrochloride (API)

1. Dr. Reddy's Laboratories

Profile: India-based pharmaceutical company with a strong presence in APIs and finished formulations.
Offerings: Supplies high-purity moxifloxacin hydrochloride API with proven compliance to international standards.
Certifications: GMP, ISO 9001, ISO 13485 (for ophthalmic products).
Reputation: Known for reliable supply and cost-competitive pricing.

2. Zhejiang Hisoar Pharmaceutical Co., Ltd.

Profile: Chinese manufacturer specializing in antibiotics, including fluoroquinolones.
Offerings: Produces moxifloxacin hydrochloride API with global export capabilities.
Certifications: GMP, ISO 9001, and CE certification.
Strengths: Competitive pricing and extensive export network.

3. Hanwha Chemical Corporation

Profile: South Korean pharmaceutical raw material supplier.
Offerings: Provides high-quality moxifloxacin hydrochloride API backed by robust quality systems.
Certifications: GMP and international quality standards compliance.

4. Solara Active Pharma Sciences

Profile: Indian pharmaceutical ingredient manufacturer.
Offerings: Supplies moxifloxacin hydrochloride API with a focus on quality and cost efficiency.
Certifications: GMP, ISO 9001:2015.

5. Envirobiotech

Profile: Manufacturer based in India specializing in pharmaceutical APIs, including fluoroquinolones.
Offerings: API with consistent batch-to-batch quality, compliant with global standards.

Suppliers of Finished Pharmaceutical Products (FPP)

While many companies produce API, the formulation of moxifloxacin hydrochloride in sodium chloride 0.8% in plastic containers is often executed by specialized contract manufacturers or pharmaceutical companies with sterile manufacturing facilities.

1. Novartis AG

Overview: Global leader in ophthalmology, producing Moxeza (moxifloxacin ophthalmic solution).
Packaging: Uses high-quality polyethylene or polypropylene bottles, often in plastic containers.
Regulatory Status: Extensive approval portfolio globally, including FDA and EMA.

2. Alcon (a Novartis subsidiary)

Offering: Moxeza and vigamox formulations in plastic ophthalmic containers.
Distribution: Widely available in global markets; known for consistent product quality.

3. Sagent Pharmaceuticals

Profile: Offers generic injectable antibiotics, including moxifloxacin hydrochloride in sodium chloride 0.8%.
Strengths: Focuses on sterile, ready-to-use injectable formulations in plastic containers meeting FDA standards.

4. Hikma Pharmaceuticals

Details: Produces sterile injectable antibiotics, including moxifloxacin hydrochloride formulations.
Packaging: Utilizes plastic containers suitable for clinical use and hospital settings.

Contract Manufacturing Organizations (CMOs)

For companies seeking manufacturing partnerships or toll manufacturing, reputable CMOs offer sterile production, formulation development, and packaging services:

Cipla Ltd.: India-based, with capabilities in sterile injectable manufacturing.
Hovione: Portugal-based, specializing in sterile formulations and supply chain management.
Vetter Pharma: Germany-based, focused on injectable and ophthalmic products in plastic containers.

Regulatory and Quality Considerations

Suppliers must demonstrate compliance with GMP, evidencing batch consistency, absence of contaminants, and proper stability profiles. For injectable formulations, sterility assurance, endotoxin levels, and preservative quality are critical quality attributes. Regulatory approvals and certifications (e.g., CNAS, EDQM certificates) strengthen supplier credibility.

Conclusion

Securing a reliable supplier for moxifloxacin hydrochloride in sodium chloride 0.8% in plastic containers involves evaluating API manufacturers like Dr. Reddy's, Zhejiang Hisoar, and Hanwha, alongside finished product manufacturers such as Novartis, Sagent Pharmaceuticals, and Hikma. For formulations, engaging with CMOs specializing in sterile injectable manufacturing ensures adherence to quality and regulatory standards.

Key Takeaways

API suppliers include reputable organizations such as Dr. Reddy's, Zhejiang Hisoar, and Hanwha, offering high-purity moxifloxacin hydrochloride compliant with international standards.
Finished product manufacturers like Novartis and Sagent Pharmaceuticals produce clinically approved formulations in plastic containers suitable for diverse healthcare settings.
Contract manufacturing organizations provide specialized sterile formulation services, ensuring product quality and regulatory compliance.
Secure supplier partnerships should prioritize GMP certification, proven stability data, and regulatory approvals, reducing supply chain risks.
Continuous supplier evaluation and quality audits are essential to maintain compliance, product integrity, and supply continuity.

FAQs

1. What are the primary criteria for selecting suppliers of moxifloxacin hydrochloride in sodium chloride 0.8%?
Selection criteria include GMP compliance, product purity, batch consistency, regulatory certifications, supply capacity, and competitive pricing.

2. Are there regional differences in supplier offerings?
Yes, regional manufacturers such as those in India, China, and South Korea dominate API supplies, while finished formulations are often produced in Europe, the US, or India, depending on regulatory requirements and market access.

3. Can these suppliers provide custom formulations or packaging solutions?
Many CMOs and API manufacturers offer contract manufacturing, including customized formulations, container types, and packaging tailored to client needs.

4. What regulatory considerations should be addressed when sourcing from these suppliers?
It is essential to verify a supplier’s GMP certification, product registration status in the target market, stability data, and adherence to regional pharmaceutical regulations.

5. How important is the stability data for selecting a supplier?
Critical; stability data ensure the product maintains efficacy and safety over its shelf life, aiding regulatory approval and patient safety.

Sources:
[1] World Health Organization. "Pharmaceuticals: Quality Assurance & Control."
[2] U.S. Food and Drug Administration. "Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing."
[3] European Directorate for the Quality of Medicines & Healthcare. "European Pharmacopoeia."
[4] Company Websites and Product Portfolios of Dr. Reddy’s, Zhejiang Hisoar, Novartis, Sagent Pharmaceuticals.

Suppliers and packagers for MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER