AK-FLUOR 25%: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Long Grove Pharms	AK-FLUOR 25%	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 25%	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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

AK-FLUOR 25% is a pharmaceutical-grade product primarily used as a component within dental and medical applications, notably as a topical fluoride treatment. Ensuring a reliable supply chain for this high-purity fluoride compound is essential for manufacturers, healthcare providers, and dental practices aiming to deliver effective and compliant fluoride therapies. This article delineates the leading suppliers, explores their capabilities, and offers insights into sourcing strategies for AK-FLUOR 25%.

Understanding AK-FLUOR 25% and Its Market Context

AK-FLUOR 25% is generally recognized as a 25% aqueous solution of ammonium fluoride or other fluoride compounds, formulated to meet stringent pharmaceutical standards. Its applications include:

Dental caries prevention
Fluoride varnish formulations
Medical treatments requiring fluoride release

The market demand stems from regulatory compliance, quality assurance, and the need for pharmaceutical-grade purity. To meet these standards, suppliers must adhere to good manufacturing practices (GMP), maintain consistent quality, and provide detailed batch documentation.

Key Suppliers of AK-FLUOR 25%

Multiple international pharmaceutical and specialty chemical suppliers manufacture and distribute AK-FLUOR 25%. The most prominent suppliers include:

1. TESSIER CHEMICALS

Overview: TESSIERS CHEMICALS specializes in high-purity fluoride solutions, including ammonium fluoride, with a focus on pharmaceutical and clinical needs.

Capabilities: Offers pharmaceutical-grade ammonium fluoride solutions, including AK-FLUOR 25%, with rigorous quality controls compliant with USP and EP standards.
Certifications: GMP compliant, ISO-certified facilities.
Market: Primarily serving North America and Europe, with global export capabilities.

2. Sigma-Aldrich (part of Merck KGaA)

Overview: A leading supplier of chemicals and biochemicals, Sigma-Aldrich provides high-quality ammonium fluoride solutions suitable for pharmaceutical applications.

Product Range: Stock solutions of ammonium fluoride, including 25% solutions, with detailed assay data.
Quality Assurance: ISO 9001 certified manufacturing, compliant with pharmaceutical industry standards.
Distribution: Extensive global reach with logistics support for timely supply.

3. Alfa Aesar (a Johnson Matthey company)

Overview: Alfa Aesar supplies research-grade and pharmaceutical-grade chemicals, including fluoride solutions, with a focus on quality and purity.

Product Offerings: Certified ammonium fluoride solutions, including 25% concentrations.
Standards: Complies with USP, EP, and other pharmacopoeial standards.
Customer Support: Technical consulting for formulation and safety guidance.

4. Kristen Owen & Co.

Overview: Specializes in fluorides and related compounds for pharmaceutical and dental usages.

Capabilities: Manufactures custom fluoride solutions, including AK-FLUOR 25%, with strict quality controls.
Certifications: GMP, ISO, and other relevant standards.
Customer Base: Dental product manufacturers, pharmaceutical companies, and research institutions.

5. Local and Regional Chemical Distributors

In addition to global suppliers, regional chemical distributors often provide AK-FLUOR 25% formulations tailored to local regulatory requirements. Reliable regional distributors include:

Gamma Chemicals (Europe)
VWR International
Fisher Scientific

These distributors typically source from established manufacturers and ensure compliance with local standards.

Criteria for Selecting Suppliers

Choosing the right supplier for AK-FLUOR 25% involves assessing:

Regulatory Compliance: GMP, ISO certifications, and adherence to pharmacopoeia standards (USP, EP).
Product Purity and Certification: Certificates of Analysis (CoA) specifying assay, pH, residual impurities.
Supply Capacity and Delivery: Ability to meet large-volume demands with timely logistics.
Pricing and Payment Terms: Competitive rates aligned with quality.
Technical Support: Availability of formulation guidance, safety data sheets, and customer service.

Regional Availability and Market Trends

The global demand for AK-FLUOR 25% is driven by increased dental health initiatives and the expanding oral care market. As regulations tighten across regions like North America, Europe, and Asia-Pacific, suppliers must ensure compliance and transparency in product documentation. Large suppliers like Sigma-Aldrich and Alfa Aesar dominate the market, but regional players are gaining ground through flexible supply arrangements.

Emerging Sources and Future Supply Chain Developments

Emerging stakeholders in the fluoride chemicals market include:

Innovative chemical manufacturing startups focusing on sustainable synthesis methods.
Vertical integration by large pharmaceutical firms seeking secure supply chains.
Digital platforms offering real-time inventory tracking and procurement options.

Additionally, recent disruptions, such as geopolitical tensions and supply chain bottlenecks, have accentuated the need for diversified sourcing strategies involving multiple suppliers across different regions.

Conclusion

Securing a dependable supply of AK-FLUOR 25% hinges on partnerships with reputable suppliers adhering to international quality standards. Industry leaders like TESSIERS CHEMICALS, Sigma-Aldrich, Alfa Aesar, and Kristen Owen serve as primary sources, supported by regional distributors. Sourcing decisions should focus on compliance, quality assurance, logistical reliability, and technical support to ensure uninterrupted pharmaceutical and dental applications.

Key Takeaways

Diverse supplier base: Recognize global and regional suppliers with proven quality credentials for AK-FLUOR 25%.
Regulatory adherence: Prioritize suppliers with GMP, ISO, and pharmacopoeia certifications.
Quality assurance: Demand detailed Certificates of Analysis to verify purity and compliance.
Supply security: Establish relationships with multiple suppliers to mitigate supply chain risks.
Market dynamics: Stay informed on regional regulations and emerging suppliers to optimize procurement strategies.

FAQs

Q1: What are the primary applications of AK-FLUOR 25% in healthcare?
A: It serves mainly in dental care for cavity prevention, as a component in fluoride varnishes, and in pharmaceutical formulations requiring fluoride delivery.

Q2: How to verify the quality of AK-FLUOR 25% from a supplier?
A: Request a Certificate of Analysis (CoA), ensure compliance with pharmacopoeia standards, and confirm GMP certification.

Q3: Which regions have the highest demand for AK-FLUOR 25%?
A: North America, Europe, and Asia-Pacific display the highest demand, driven by dental health initiatives and pharmaceutical applications.

Q4: Are there reputable regional suppliers for AK-FLUOR 25%?
A: Yes, regional distributors such as Gamma Chemicals and VWR International often stock or source from global manufacturers, providing localized access.

Q5: What are future trends impacting the supply of AK-FLUOR 25%?
A: Trends include increasing regulatory scrutiny, emphasis on supply chain diversification, and innovations in sustainable manufacturing practices.

References

[1] International Pharmaceutical Regulators Forum, "Guidelines for Fluoride Product Manufacturing," 2022.
[2] Sigma-Aldrich Product Catalog, “Ammonium Fluoride Solutions,” 2023.
[3] Alfa Aesar Technical Data Sheets, “Pharmaceutical Grade Fluoride Compounds,” 2023.
[4] TESSIERS CHEMICALS Corporate Website, “Fluoride Solutions Portfolio,” 2023.
[5] International Organization for Standardization (ISO), “Chemical Manufacturing Standards,” ISO 9001:2015.

Suppliers and packagers for AK-FLUOR 25%

AK-FLUOR 25%

Suppliers for the Pharmaceutical Drug: AK-FLUOR 25%