Bulk Pharmaceutical API Sources for SYNALAR

Bulk Pharmaceutical API Sources for SYNALAR

Vendor	Vendor Homepage	Vendor Sku	API Url
TCI (Tokyo Chemical Industry)		F0657
Molport		MolPort-002-528-328
Hangzhou APIChem Technology		AC-429
AKos Consulting & Solutions		AKOS015963144
Finetech Industry Limited		FT-0631295
AbaChemScene		CS-2519
MedChemexpress MCE		HY-B0415

Bulk Active Pharmaceutical Ingredient (API) Sources for SYNALAR

Last updated: July 30, 2025

Introduction
SYNALAR, a topical corticosteroid formulated as fluocinolone acetonide, is prescribed for inflammatory skin conditions such as eczema, psoriasis, and dermatitis. The active pharmaceutical ingredient (API), fluocinolone acetonide, is a potent synthetic corticosteroid, requiring high purity standards for safety and efficacy. The procurement of quality API is critical for pharmaceutical manufacturers aiming to produce compliant, effective formulations of SYNALAR. This analysis provides an overview of the global sources of bulk fluocinolone acetonide, emphasizing manufacturer profiles, geographic distribution, regulatory compliance, and market dynamics.

Global API Manufacturing Landscape

Major API Producers for Fluocinolone Acetonide

Several multinational and regional manufacturers supply fluocinolone acetonide bulk APIs. These companies vary in scale, regulatory reputation, and geographical scope.

1. European Manufacturers

Europe remains a significant hub for high-quality corticosteroid APIs, with stringent regulatory oversight and a reputation for rigorous quality standards.

• Siegfried AG (Switzerland):
  Siegfried possesses advanced synthesis capabilities and supplies bulk fluocinolone acetonide to the global market, adhering to European Good Manufacturing Practices (GMP). Their facilities maintain Annex 1 compliance, ensuring high purity and consistent batch-to-batch quality.

• BASF SE (Germany):
  Known for comprehensive chemical expertise, BASF offers pharmaceutical intermediates and APIs. It manufactures fluocinolone acetonide with a focus on high purity and compliance with EMA standards, positioning it as a top-tier supplier.

2. Asian Manufacturers

Asia, especially India and China, hosts numerous API manufacturers due to cost advantages and expanding infrastructure.

• Hetero Labs (India):
  Hetero is an established pharmaceutical producer with a strong portfolio in corticosteroids. They supply fluocinolone acetonide in GMP-compliant facilities catering to global markets, including North America, Europe, and Asia.

• Zhejiang Hisoar Pharmaceuticals (China):
  This Chinese manufacturer supplies bulk fluocinolone acetonide to regional and international clients, with a focus on competitive pricing and functional compliance with international standards.

• Granules India (India):
  Known for producing various corticosteroids, Granules India offers fluocinolone acetonide APIs with separation and purification processes aligned with global quality standards.

3. North American and Other Markets

Limited but noteworthy producers exist in North America and other regions, primarily serving domestic markets or via licensing agreements.

• CoreRx Inc. (USA):
  While primarily a pharmaceutical co-processor, CoreRx acts as a broker and supplier of high-quality APIs, including fluocinolone acetonide, adhering to FDA regulations.

Market Trends and Demand Dynamics

• The demand for fluocinolone acetonide stems from dermatology-focused generic formulations and branded products, including SYNALAR.
• Increasing regulatory requirements have led suppliers to enhance quality assurance measures, emphasizing GMP compliance.
• Cost considerations influence procurement strategies, with end-users balancing price against quality, regulatory approval, and supply chain reliability.

Regulatory and Quality Compliance

Suppliers of fluocinolone acetonide must meet stringent regulatory standards:

• GMP Certification:
  Ensures API quality, safety, and consistent supply, critical for manufacturers of topical corticosteroids like SYNALAR.

• Pharmacopoeia Standards:
  All suppliers aiming for global markets conform to USP, EP, or JP monographs, which specify impurity profiles, potency, and physicochemical parameters.

• Environmental and Ethical Standards:
  Suppliers increasingly adopt environmentally responsible manufacturing practices, reflecting global trends and customer expectations.

Supply Chain Considerations

• Reliability:
  Long-term partnerships with trusted manufacturers ensure supply stability amid fluctuating demand.

• Pricing:
  Asian manufacturers generally offer more competitive pricing, though logistical and regulatory factors may influence final costs.

• Traceability:
  Transparent documentation and batch traceability are vital for compliance and quality assurance, especially for regulated markets.

Conclusion
The procurement of fluocinolone acetonide API for SYNALAR manufacturing involves a global network of suppliers, primarily located in Europe and Asia. European producers like Siegfried and BASF lead in quality and regulatory reputation, while Indian and Chinese manufacturers provide cost-effective options that meet international standards. Pharmaceutical companies must evaluate suppliers based on quality certifications, regulatory compliance, supply stability, and cost to ensure consistent product efficacy and safety.

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Key Takeaways

• Top-tier Suppliers: European firms such as Siegfried and BASF guarantee high-quality, GMP-compliant fluocinolone acetonide APIs for SYNALAR.
• Cost-Effective Alternatives: Indian and Chinese manufacturers offer competitive pricing, with quality aligned to international standards, suitable for regional markets.
• Regulatory Vigilance: Ensuring API suppliers maintain GMP certification and adhere to pharmacopoeia standards is essential for regulatory approval and product safety.
• Supply Chain Reliability: Establishing robust vendor relationships and ensuring traceability minimizes risks associated with supply disruptions or quality lapses.
• Market Dynamics: The global corticosteroid API market is evolving, driven by rising demand for dermatological therapies and strict quality standards.

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FAQs

1. What are the primary regions supplying fluocinolone acetonide API for SYNALAR?
Europe and Asia are the leading regions, with European manufacturers like Siegfried and BASF providing high-quality APIs, while India and China offer cost-effective options from companies like Hetero Labs and Zhejiang Hisoar Pharmaceuticals.

2. How do quality standards differ among API suppliers?
European manufacturers typically adhere to stricter regulatory standards such as EMA and GMP, ensuring higher quality assurance. Asian suppliers compliant with GMP, USP, or EP standards can reliably meet international requirements, though due diligence is necessary.

3. What factors should manufacturers consider when selecting an API supplier?
Manufacturers should evaluate regulatory compliance (GMP certification), purity and impurity profile, supply stability, cost, traceability, and environmental practices in the supplier's operations.

4. Is there a significant price difference between European and Asian API sources?
Yes. European APIs generally cost more due to higher manufacturing costs and regulatory investments, whereas Asian manufacturers offer competitive pricing, necessitating careful quality assessments.

5. How does global regulatory oversight impact API sourcing for SYNALAR?
Stringent regulations demand certified, GMP-compliant APIs. Suppliers must maintain comprehensive documentation and quality controls to ensure acceptance in regulated markets like the US, Europe, and Japan.

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Sources
[1] European Medicines Agency, "Guidelines on the requirements for the manufacture of corticosteroids."
[2] BASF, "API Portfolio: Pharmaceutical APIs," 2022.
[3] Hetero Labs, "API Manufacturing Capabilities & Quality Standards," 2023.
[4] Chinese Pharmacopoeia, "Standards for corticosteroid APIs," 2022.
[5] Global API Market Insights, "Supply trends and market dynamics," 2023.