Suppliers and packagers for generic pharmaceutical drug: fluocinolone acetonide; neomycin sulfate

fluocinolone acetonide; neomycin sulfate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Medimetriks Pharms	NEO-SYNALAR	fluocinolone acetonide; neomycin sulfate	CREAM;TOPICAL	060700	ANDA	Medimetriks Pharmaceuticals	43538-940-60	1 TUBE in 1 CARTON (43538-940-60) / 60 g in 1 TUBE	1963-06-11
Medimetriks Pharms	NEO-SYNALAR	fluocinolone acetonide; neomycin sulfate	CREAM;TOPICAL	060700	ANDA	Medimetriks Pharmaceuticals	43538-940-99	4 TUBE in 1 CARTON (43538-940-99) / 3 g in 1 TUBE	1963-06-11

Suppliers for the Pharmaceutical Drugs: Fluocinolone Acetonide; Neomycin Sulfate

Last updated: August 5, 2025

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Introduction

The pharmaceutical supply chain for critical medications like fluocinolone acetonide combined with neomycin sulfate involves a complex network of manufacturers, distributors, and authorized suppliers. These compounds are widely used in dermatology, otolaryngology, and ophthalmology to treat inflammatory and infectious conditions. Ensuring reliable sourcing necessitates understanding the top suppliers, manufacturing standards, and regulatory landscape influencing procurement decisions.

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Fluocinolone Acetonide and Neomycin Sulfate: An Overview

Fluocinolone Acetonide is a synthetic corticosteroid with potent anti-inflammatory properties. It is often compounded with antibiotics like neomycin sulfate for topical applications, particularly in treating skin infections and inflammatory dermatitis.

Neomycin Sulfate is an aminoglycoside antibiotic effective against gram-negative bacteria and certain gram-positive strains. When combined with fluocinolone acetonide, it provides both anti-inflammatory and antimicrobial action, making it a staple in multi-use formulations.

The synthesis, quality control, and distribution of these compounds are regulated by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with manufacturers requiring Good Manufacturing Practices (GMP) certification.

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Leading Suppliers and Manufacturers

1. Major Pharmaceutical Companies

Several global pharmaceutical conglomerates manufacture both fluocinolone acetonide and neomycin sulfate, either as proprietary brands or as active pharmaceutical ingredients (APIs):

• Mylan (now part of Viatris): Mylan has a significant presence in producing corticosteroids and antibiotics, including fluocinolone acetonide. It supplies both APIs and finished dosage forms across North America, Europe, and emerging markets.

• Sandoz (a Novartis division): Sandoz is recognized for its sterile injectables and topical formulations, offering high-quality fluocinolone acetonide products and APIs conforming to international standards.

• Fresenius Kabi: Known for generic APIs, especially corticosteroids and antibiotics. The company supplies neomycin sulfate APIs and preparation-grade formulations.

• TEVA Pharmaceuticals: A global leader in generics, TEVA manufactures both fluocinolone acetonide and neomycin sulfate APIs for various markets.

• Hubei Biocause Pharmaceutical Co., Ltd.: Leading Asian producer of neomycin sulfate, often supplying bulk APIs to regional and international companies.

2. Contract Manufacturing and API Suppliers

Many generic and brand-name companies source APIs from specialized contract manufacturers:

• Hainan Kangyuan Pharmaceutical Co., Ltd.: Chinese manufacturer producing high-grade fluocinolone acetonide for both domestic and export markets.

• Shanghai Laboratory Equipment Co., Ltd.: Supplies laboratory-grade fluocinolone acetonide, often used in research and development.

• Daewoong Pharmaceutical Co., Ltd. (South Korea): Produces neomycin sulfate API with Good Manufacturing Practices (GMP) compliance.

3. Distributors and Authorized Suppliers

These firms facilitate distribution and supply chain management:

• Sigma-Aldrich/Merck: Offers pharmaceutical-grade APIs and excipients, including fluocinolone acetonide and neomycin sulfate, suitable for research and small-scale compounding.

• Alibaba and Global Sources: While not manufacturers, these platforms connect buyers with API suppliers, often from China and India. Buyers should verify GMP certification and quality standards.

4. Regional Suppliers and Market-Specific Sources

• India: Companies like Sun Pharma, Aurobindo Pharma, and Lupin produce APIs and finished formulations, often exporting to global markets.

• China: A major source for bulk APIs, including fluocinolone acetonide and neomycin sulfate, with various manufacturers offering competitive pricing but requiring stringent quality verification.

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Quality and Regulatory Considerations

Sourcing steroids and antibiotics requires accreditation compliance:

• GMP Certification: Ensures consistent quality and safety (e.g., FDA, EMA, WHO audits).

• Third-party Certification: Suppliers should hold certifications from agencies like the Drug Master File (DMF), ISO standards, and CE markings where applicable.

• Import Regulations: Different countries have specific regulations governing API imports, including registration, safety, and efficacy requirements.

Due Diligence: Pharmaceutical purchasers must validate supplier credentials, audit manufacturing facilities, and review quality control documentation before procurement.

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Emerging Trends and Market Dynamics

• Shift Toward Diversification: Due to geopolitical and supply chain disruptions, companies increasingly diversify suppliers to mitigate risks.

• Regulatory Harmonization: International standards are streamlining approval processes, encouraging suppliers to maintain globally recognized certifications.

• Pricing Pressures: Competitive sourcing from emerging markets like India and China influences price dynamics, but buyers must prioritize quality assurance.

• Supply Chain Transparency: Increasing demand for traceability, especially for APIs used in compounded medications, emphasizing the importance of verified suppliers.

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Conclusion

Reliable sourcing for fluocinolone acetonide and neomycin sulfate hinges on a combination of reputable manufacturers, GMP-compliant suppliers, and thorough vetting processes. Global pharmaceutical companies and regional suppliers play pivotal roles in fulfilling supply chains, with Asia-Pacific regions serving as primary production hubs. Business professionals should prioritize quality certifications, regulatory compliance, and supply chain resilience when selecting suppliers.

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Key Takeaways

• The leading global manufacturers of fluocinolone acetonide and neomycin sulfate include Mylan, Sandoz, Fresenius Kabi, TEVA, and regional Asian producers.

• Ensuring GMP certification and regulatory compliance is crucial in safeguarding medication quality and safety standards.

• Diversification of suppliers mitigates risks associated with geopolitical issues and market volatility.

• Asian countries, notably India and China, supply a significant share of APIs, emphasizing the need for rigorous supplier verification.

• As demand increases and regulatory standards evolve, transparent supply chains and quality assurance remain critical operational priorities.

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FAQs

1. What factors should I consider when selecting a supplier for fluocinolone acetonide and neomycin sulfate?
Prioritize GMP certification, regulatory compliance, quality control measures, supply stability, and traceability. Verify supplier credentials and conduct audits if possible.

2. Are there notable regional differences in supplier reliability for these compounds?
Yes. Western suppliers often adhere to stricter regulatory standards, whereas Asian manufacturers offer competitive pricing but require thorough qualification procedures to ensure quality.

3. How can I verify the quality of API sources from new suppliers?
Request official documentation such as Certificates of Analysis (CoA), GMP certificates, and third-party testing results. Conduct audits and consider third-party inspections.

4. What is the impact of global supply chain disruptions on these APIs?
Disruptions can lead to shortages and increased costs. Diversifying suppliers and maintaining safety stock can mitigate potential impacts.

5. How do regulatory changes affect the procurement of fluocinolone acetonide and neomycin sulfate?
Regulatory updates may impose stricter quality and documentation requirements, influencing sourcing strategies and necessitating ongoing supplier assessments.

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References

[1] "Global API Market Overview," Pharmaceutical Technology, 2022.
[2] "GMP Certification and Its Impact," World Health Organization, 2021.
[3] "Asian API Suppliers: Market Trends," Pharmaceutical Commerce, 2023.
[4] "Regulatory Compliance in API Sourcing," FDA Guidelines, 2023.
[5] "Supply Chain Resilience in Pharmaceuticals," Bloomberg Intelligence, 2022.