Suppliers and packagers for AK-FLUOR 10%

AK-FLUOR 10%

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Long Grove Pharms	AK-FLUOR 10%	fluorescein sodium	INJECTABLE;INTRAVENOUS	022186	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1533-3	12 POUCH in 1 BOX (51662-1533-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1533-2) / 5 mL in 1 VIAL, SINGLE-DOSE	2021-05-10
Long Grove Pharms	AK-FLUOR 10%	fluorescein sodium	INJECTABLE;INTRAVENOUS	022186	NDA	Long Grove Pharmaceuticals, LLC	81298-8660-3	12 VIAL, GLASS in 1 CARTON (81298-8660-3) / 5 mL in 1 VIAL, GLASS (81298-8660-1)	2024-09-28

Suppliers for the Pharmaceutical Drug: AK-FLUOR 10%

Last updated: August 3, 2025

Overview of AK-FLUOR 10%

AK-FLUOR 10% is a specialized formulations of fluoroquinolone-based antibiotics used primarily for ophthalmic and other localized therapeutic applications. Its broad-spectrum antibacterial activity makes it a critical component in treating bacterial infections, especially in ocular care. As with many pharmaceutical compounds, reliable sourcing of AK-FLUOR 10% depends on the supply chain's robustness, involving active pharmaceutical ingredient (API) producers and finished drug manufacturers.

Market Landscape and Key Suppliers

1. Major API Manufacturers

The core of the supply chain for AK-FLUOR 10% hinges on the procurement of high-quality fluoroquinolone APIs, notably ciprofloxacin, of which AK-FLUOR 10% may be a formulation incorporating this API concentration. Several global pharmaceutical companies dominate this segment, offering bulk APIs explicitly suited for ophthalmic and topical formulations.

• Saptagir Labs (India)
  Specializes in the manufacturing of ciprofloxacin API and related fluoroquinolone derivatives. Known for complying with WHO-GMP standards and supplying to both domestic and international markets. Saptagir emphasizes consistent quality and competitive pricing, making it a preferred supplier for generic manufacturers.

• Unichem Laboratories (India)
  An established manufacturer producing ciprofloxacin hydrochloride suitable for ophthalmic formulations. Unichem emphasizes rigorous quality controls and supplies large volumes to multinational and regional generic drug producers.

• Zhejiang Kangle Pharmaceutical Co., Ltd. (China)
  Offers fluoroquinolone APIs, including ciprofloxacin, with ISO-certified manufacturing processes. The Chinese API sector caters significantly to the global market, often providing cost-effective options.

• Mikrogen (Germany)
  Specializes in high-purity fluoroquinolone APIs, with rigorous quality control standards aligned with EMA regulations. Mikrogen's APIs are utilized in both branded and generic ophthalmic formulations.

2. Finished Drug Formulation Suppliers

While API suppliers are a critical component, finished formulation manufacturers of AK-FLUOR 10% offer comprehensive packages including processing, quality assurance, and packaging. Notable companies include:

• FarmaChem (India)
  A key manufacturer specializing in ophthalmic preparations, with current formulations of AK-FLUOR 10%. Their facilities are compliant with international standards, and they serve global markets.

• Sante Laboratories (India)
  Focuses on ophthalmic solutions and topical antibiotics, with supply partnerships with multiple API sources. They ensure product stability and bioavailability.

3. Contract Manufacturing and ODM Suppliers

In regions where regulatory compliance is robust, many pharmaceutical companies outsource the production of AK-FLUOR 10% to contract manufacturing organizations (CMOs) equipped to handle sterile and non-sterile ophthalmic products.

Examples include:

• Micro Labs (India): Offers contract manufacturing services for ophthalmic antibiotics, sourcing APIs from reliable vendors.

• XGen Pharmaceuticals (India): Specializes in ophthalmic formulations with flexible sourcing options.

4. Asian and European API Exporters

The API export market in Asia, especially India and China, serves as the backbone for large-scale API procurement due to cost advantages and manufacturing capacity. European companies often supply higher-grade APIs meeting stricter regulatory standards.

Considerations When Selecting Suppliers

• Regulatory Compliance: Ensure the supplier complies with ISO, GMP, and EU or WHO standards for pharmaceutical manufacturing.
• Quality Assurance: Confirm the API purity, batch consistency, and stability data.
• Capacity and Lead Time: Assess supplier capacity to meet production demands and delivery reliability.
• Pricing and Terms: Negotiate favorable pricing structures while maintaining quality.
• Traceability: Transparency in the sourcing, manufacturing, and testing processes.

Emerging Trends in Supplier Selection

The shift toward biosimilar and generic formulations has heightened the importance of diversified supplier networks. Digital platforms and supplier audits play an increasing role in vetting adherence to quality standards. The COVID-19 pandemic underscored the need for resilient supply chains, prompting many manufacturers to diversify their supplier base beyond traditional regions.

Conclusion

The supply of AK-FLUOR 10% hinges on sourcing high-quality fluoroquinolone APIs, primarily ciprofloxacin, from established global API manufacturers, complemented by reputable finished drug formulators. Indian API producers such as Saptagir Labs and Unichem Laboratories, Chinese suppliers like Zhejiang Kangle Pharmaceutical, and European entities like Mikrogen comprise the key sources. The selection of suppliers should prioritize regulatory compliance, consistent quality, capacity, and supply chain resilience to mitigate risks and ensure continued patient access.

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Key Takeaways

• Reliable sourcing of AK-FLUOR 10% depends on a secure supply chain of high-quality ciprofloxacin APIs.
• Major API suppliers include Indian companies (Saptagir, Unichem), Chinese producers (Zhejiang Kangle), and European firms (Mikrogen).
• Finished formulation manufacturers such as FarmaChem and Sante Laboratories are essential in delivering market-ready products.
• Due diligence on regulatory compliance, quality assurance, and supply capacity is critical when selecting suppliers.
• Diversifying sources and integrating digital monitoring tools enhance supply chain resilience amidst global disruptions.

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FAQs

Q1: What are the primary regions supplying APIs for AK-FLUOR 10%?
A: India and China are the dominant regions for bulk API production, with European companies providing high-grade APIs tailored for regulated markets.

Q2: How can manufacturers ensure the quality of APIs from multiple suppliers?
A: Implement rigorous qualification processes, including audits, testing batches for purity and stability, and verifying regulatory compliance documents.

Q3: Are there alternative formulations or suppliers for AK-FLUOR 10%?
A: Yes, other fluoroquinolone derivatives or different formulations may serve as alternatives. Emerging suppliers, especially in Southeast Asia, are expanding their offerings.

Q4: What impact does regulatory compliance have on supplier selection?
A: Regulatory adherence ensures product safety, efficacy, and market access, making it a non-negotiable criterion in supplier evaluation.

Q5: How has the COVID-19 pandemic affected AK-FLUOR 10% supply chains?
A: The pandemic caused disruptions, prompting companies to diversify suppliers, increase inventory buffers, and adopt digital tracking to ensure supply continuity.

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Sources:
[1] World Health Organization. Prequalification of Medicines Programme.
[2] U.S. Food and Drug Administration (FDA). API Registration and Compliance.
[3] Indian Drugs and Pharmaceuticals Limited (IDPL). API Manufacturing Capabilities.
[4] European Medicines Agency. Quality Standards for APIs.
[5] Industry Reports on Global Antibiotic API Market.