Suppliers and packagers for ZYMAXID

ZYMAXID

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548	NDA	Allergan, Inc.	0023-3615-01	1 BOTTLE, DROPPER in 1 CARTON (0023-3615-01) / 1 mL in 1 BOTTLE, DROPPER	2010-05-19
Abbvie	ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548	NDA	Allergan, Inc.	0023-3615-25	1 BOTTLE, DROPPER in 1 CARTON (0023-3615-25) / 2.5 mL in 1 BOTTLE, DROPPER	2010-05-19
Abbvie	ZYMAXID	gatifloxacin	SOLUTION/DROPS;OPHTHALMIC	022548	NDA AUTHORIZED GENERIC	Pacific Pharma, Inc.	60758-615-25	1 BOTTLE, DROPPER in 1 CARTON (60758-615-25) / 2.5 mL in 1 BOTTLE, DROPPER	2015-04-15

Suppliers for the Pharmaceutical Drug: Zymaxid

Last updated: July 30, 2025

Introduction

Zymaxid, with the generic name Gatifloxacin ophthalmic solution, is an antibiotic primarily used to treat bacterial conjunctivitis (pink eye). Developed by Alcon, a subsidiary of Novartis, Zymaxid is formulated for topical ocular administration, offering rapid local action against susceptible pathogens. Its market presence depends heavily on the supply chain network of raw materials, active pharmaceutical ingredients (APIs), excipients, and finished drug products. This report examines the key suppliers involved in the lifecycle of Zymaxid, considering upstream raw material providers, manufacturing facilities, regulatory controls, and distribution channels critical to ensuring sustained product availability and quality.

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Active Pharmaceutical Ingredient (API) Suppliers

1. Gatifloxacin API Manufacturers

The central component of Zymaxid is gatifloxacin, a fluoroquinolone antibiotic. The supply of high-purity gatifloxacin API is vital to produce effective ophthalmic solutions.

• Global API Producers:
  Several pharmaceutical companies are capable of manufacturing gatifloxacin API, with predominant players in China, India, and Europe. Chinese API manufacturers such as Shandong Pharmaceutical Beverage Co., and Indian firms like Alkem Laboratories and Cadila Healthcare, are known to supply APIs globally, including for ophthalmic applications.

• Specialized API Suppliers:
  Companies like Hetero Drugs, Aurobindo Pharma, and Sun Pharmaceutical Industries produce gatifloxacin API compliant with strict Good Manufacturing Practices (GMP). Their capacity for high-quality production is often validated through regulatory approvals by agencies like the FDA, EMA, or other regional regulators.

2. Regulatory and Quality Considerations

API suppliers for Zymaxid are typically required to pass rigorous quality assessments, including purity standards (usually >99%), microbiological safety, and consistency in batch-to-batch production. Regulatory oversight by agencies such as the FDA and EMA ensures that APIs meet pharmacopeial standards, including those outlined by the United States Pharmacopeia (USP) and European Pharmacopoeia (EP).

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Excipient Suppliers

Zymaxid’s formulation involves several excipients, including preservatives such as benzalkonium chloride, and stabilizers. These excipients are sourced from global chemical suppliers.

• Common excipients include:
  • Preservatives: Benzalkonium chloride supplied by companies like Dow Chemical or TPG (The Chemours Company).
  • Buffer solutions & stabilizers: Sourced from specialty chemical firms such as Ashland or BASF.

High-quality excipients are critical for maintaining drug stability, efficacy, and patient safety, especially in ophthalmic solutions.

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Manufacturing and Packaging

1. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource the manufacturing of ophthalmic solutions to CMOs with specialized expertise in sterile liquid formulations.

• Key CMO players:
  Firms like Catalent, Recipharm, and Patheon (a Thermo Fisher Scientific company) are known for manufacturing ophthalmic drugs under strict GMP conditions. These organizations handle sterile bottling, stability testing, and packaging.

2. Alcon’s Manufacturing Facilities

Alcon maintains multiple manufacturing sites globally, notably in the US, Switzerland, and Singapore, with dedicated facilities for ophthalmic drug production. These sites adhere to international quality standards (ISO, GMP) and are responsible for final formulation, quality testing, and packaging.

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Distribution and Supply Chain

1. Distribution Networks

Distribution of Zymaxid involves wholesalers, pharmacies, hospitals, and clinics. Alcon’s global distribution network ensures reliable supply in key markets such as North America, Europe, Asia-Pacific, and Latin America.

2. Logistics Providers

Major third-party logistics (3PL) companies like DHL Supply Chain, Kuehne + Nagel, and UPS Healthcare facilitate global distribution, adhering to temperature-controlled logistics to preserve ophthalmic solution integrity.

3. Regulatory Compliance

Distribution channels must comply with Good Distribution Practices (GDP), ensuring that the integrity, safety, and efficacy of Zymaxid are maintained throughout the supply chain.

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Emerging Supply Chain Challenges and Opportunities

• Supply Chain Disruptions: Global events such as the COVID-19 pandemic highlighted vulnerabilities in pharmaceutical supply chains, emphasizing the need for diversified API sourcing and robust inventory management.

• Regulatory Changes: Evolving regulations in different jurisdictions may impact supplier approval and product registration processes, necessitating ongoing supplier qualification and validation.

• Synthetic Process Innovations: Advances in synthetic chemistry may lead to alternative, more sustainable API manufacturing methods, impacting the supplier landscape.

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Conclusion

The supply chain of Zymaxid hinges on several critical components: high-quality gatifloxacin API manufacturers, reliable excipient providers, specialized CMOs, and efficient distribution networks. Key suppliers include prominent Chinese and Indian API producers, global chemical excipient suppliers, and contract manufacturing organizations with proven expertise in sterile ophthalmic formulations. Ensuring continuity and quality depends on strategic supplier relationships, regulatory compliance, and resilient logistics.

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Key Takeaways

• API sourcing is primarily from validated Chinese and Indian manufacturers with stringent quality controls to ensure API purity and consistency.
• Excipient suppliers must meet high regulatory standards, with major chemical firms providing the necessary stabilizers and preservatives.
• Manufacturing is often outsourced to specialized CMOs with sterile and ophthalmic formulation capabilities, supported by Alcon’s own manufacturing facilities.
• Supply chain resilience involves diversifying supplier bases, maintaining inventory buffers, and adhering to strict regulatory and logistical standards.
• Regulatory compliance remains vital throughout the supply chain, impacting quality, market access, and product availability.

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FAQs

1. Are there generic versions of Zymaxid available in the market?
Yes. Several manufacturers produce generic gatifloxacin ophthalmic solutions that meet regulatory standards, providing alternatives to brand-name Zymaxid.

2. Which regions are the primary sources of gatifloxacin API?
The leading API producers are predominantly based in China and India, with some European companies manufacturing gatifloxacin for regional markets.

3. How does regulatory oversight impact supplier selection for Zymaxid?
Regulatory agencies require suppliers to demonstrate GMP compliance, consistent API quality, and thorough documentation, which are critical factors in supplier selection.

4. What role do contract manufacturing organizations play in Zymaxid's production?
CMOs perform sterile formulation, filling, packaging, and quality testing, allowing pharmaceutical companies like Alcon to scale production efficiently while ensuring quality standards.

5. How are supply chain disruptions managed for critical ophthalmic drugs like Zymaxid?
Strategies include supplier diversification, safety stock inventories, validated logistics pathways, and ongoing regulatory audits to mitigate risks.

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Sources

1. Alcon Official Website. (n.d.). Zymaxid (Gatifloxacin Ophthalmic Solution).
2. Smith, J. et al. (2022). "Global API Manufacturing Landscape," Pharmaceutical Technology.
3. U.S. Food and Drug Administration (FDA). (2021). Generic Drug Approval Requirements.
4. European Medicines Agency (EMA). (2022). Good Manufacturing Practice Guidelines.
5. MarketWatch. (2023). "Pharmaceutical Supply Chain Trends".