Fluocinolone Acetonide

Fluocinolone Acetonide is a potent synthetic topical corticosteroid widely used in dermatology and ophthalmology for its powerful anti-inflammatory, antipruritic, and vasoconstrictive properties. It is primarily indicated for the treatment of a variety of inflammatory skin conditions, including eczema, psoriasis, seborrheic dermatitis, and allergic reactions, as well as in certain ophthalmic and otic preparations for inflammation-related disorders.

With a growing global demand for high-quality topical corticosteroid medications, BluepillExpress offers end-to-end third-party manufacturing services for Fluocinolone Acetonide formulations. We specialize in contract manufacturing, private labeling, and global exports of dermatological and corticosteroid-based products in strict compliance with WHO-GMP, ISO 9001:2015, and regulatory agency norms.

Our mission is to help partners worldwide deliver affordable, effective, and well-tolerated steroid therapies under their own brand name with the support of a trusted pharmaceutical manufacturer.

About BluepillExpress

BluepillExpress is an established Indian pharmaceutical manufacturer and exporter, catering to clients in over 50 countries. We provide customized manufacturing services for a wide range of therapeutic categories, including dermatology, ophthalmology, neurology, cardiology, and more.

Our key offerings include:

• Third-party and contract manufacturing
• Private-label solutions
• Regulatory and documentation support
• Global distribution and logistics facilitation

We operate under stringent quality assurance systems, ensuring all products meet international standards of safety, efficacy, and stability.

Pharmacological Overview

• Drug Name: Fluocinolone Acetonide
• Pharmacological Class: Topical corticosteroid
• Therapeutic Category: Anti-inflammatory, Dermatological agent
• Potency Classification: Low to medium potency (depending on concentration)
• Route of Administration: Topical (cream, ointment, lotion, oil), Otic, Ophthalmic (by special request)

Mechanism of Action

Fluocinolone Acetonide acts by modulating the body’s inflammatory response. It works through:

• Inhibition of phospholipase A2, which reduces the production of pro-inflammatory cytokines
• Suppression of leukocyte migration and immune cell activation
• Stabilization of lysosomal membranes, decreasing tissue damage
• Reduction in capillary permeability, minimizing swelling and redness

The result is significant relief from inflammation, itching, redness, and discomfort, making it highly effective in managing both acute and chronic skin conditions.

Indications and Therapeutic Use

Fluocinolone Acetonide formulations are commonly prescribed for:

• Eczema and Atopic Dermatitis
• Psoriasis (non-plaque type)
• Contact Dermatitis (Allergic or Irritant)
• Seborrheic Dermatitis
• Lichen Planus
• Insect bite reactions
• Scalp conditions requiring corticosteroids (in oil or solution form)
• Otic conditions such as otitis externa (with antibiotic combinations)
• Ophthalmic inflammation (under medical supervision)

Its efficacy across multiple forms and concentrations makes Fluocinolone Acetonide an essential corticosteroid in dermatology and ENT practice.

Fluocinolone Acetonide Dosage Forms Offered by BluepillExpress

BluepillExpress manufactures a variety of topical and external-use preparations with Fluocinolone Acetonide:

1. Topical Creams

• Fluocinolone Acetonide 0.01% w/w
• Base: Non-comedogenic, hypoallergenic cream base
• Available in tubes of 5g, 10g, 15g, 30g

2. Topical Ointments

• For dry, lichenified, or thickened lesions
• Moisturizing base for occlusive therapy

3. Lotions and Scalp Solutions

• Alcohol-based or aqueous-based for scalp and hairy areas
• Easy application and fast absorption

4. Topical Oils

• Fluocinolone Acetonide 0.01% in Oil Base
• For scalp psoriasis and seborrheic dermatitis
• Popular among pediatric and geriatric populations

5. Otic Solutions

• Often combined with antimicrobials (e.g., Ciprofloxacin + Fluocinolone)
• Used in otitis externa and ear canal inflammation

6. Ophthalmic Preparations (Available on request with sterile facility)

• For uveitis or post-operative ocular inflammation

We also offer customized strengths and formulations depending on regulatory approvals and client requirements.

Manufacturing Capabilities and Infrastructure

BluepillExpress operates a WHO-GMP and ISO-certified manufacturing facility designed to support a wide variety of semisolid and liquid formulations.

Key Infrastructure Features:

• Automated cream, ointment, and gel mixers with homogenizers
• Temperature-controlled mixing and filling zones
• Tube filling, sealing, and labeling lines (metal, laminated, plastic tubes)
• Solution preparation tanks for lotions and oils
• Sterile and aseptic environments (for ophthalmic and otic solutions)
• HEPA-filtered cleanrooms and in-house water treatment systems

Our facility supports batch scalability, ideal for both small launches and large institutional orders.

Quality Control and Assurance

BluepillExpress employs a strict quality control (QC) and quality assurance (QA) system at every step:

• Raw material testing: Identity, purity, microbial limits
• In-process control: Viscosity, pH, uniformity, emulsification
• Finished product analysis: Assay, microbial testing, preservative efficacy
• Packaging integrity checks
• Stability studies: Real-time and accelerated per ICH guidelines
• Dermal safety tests (non-irritation, skin tolerance) for new formulations

All products are manufactured in accordance with IP, BP, or USP standards, depending on the client’s market.

Packaging and Labeling Options

BluepillExpress offers full custom branding, private labeling, and institutional packaging for Fluocinolone Acetonide formulations.

Packaging Types:

• Tubes: Laminated, aluminum, or plastic tubes with nozzle or flip-top caps
• Bottles: HDPE or amber glass with dropper (for oil and lotion)
• Cartons: Printed with multilingual labeling and client branding
• Bulk Packs: For hospitals, tenders, or distributors

We assist in the development of regulatory-compliant artworks, patient information leaflets (PIL), and barcoded labeling.

Regulatory and Export Documentation Support

We provide a complete set of regulatory and technical documents necessary for product registration, import, and marketing:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (COPP)
• Certificate of Origin
• Free Sale Certificate
• Certificate of Analysis (COA)
• Stability Data
• Product Technical Sheet and MSDS
• Dossiers in CTD or ACTD format
• Compliance with specific regulatory authorities (NAFDAC, MoH, TFDA, etc.)

Our regulatory affairs team supports clients in filing, responding to queries, and document legalization, if required.

Private Label and Third-Party Manufacturing Services

BluepillExpress offers comprehensive third-party manufacturing services, allowing clients to launch Fluocinolone Acetonide products under their own brand name without investing in infrastructure.

Our Services Include:

• Product development and formulation adjustment (if needed)
• Manufacturing under license or market authorization
• Custom branding and packaging design
• Documentation and registration support
• Batch-wise manufacturing with full QA
• Door-to-door global shipping with logistics coordination

Our low MOQ (Minimum Order Quantity) system supports startups, while our high-volume capacity serves governments and institutional buyers.

Global Markets We Serve

BluepillExpress exports Fluocinolone Acetonide products to over 50 countries, including:

• Africa: Nigeria, Kenya, Ethiopia, Ghana, Tanzania, Sudan
• Asia: Myanmar, Cambodia, Vietnam, Nepal, Bangladesh
• Middle East: Iraq, Yemen, Jordan, UAE
• CIS: Uzbekistan, Kazakhstan, Kyrgyzstan
• Latin America: Peru, Bolivia, Dominican Republic

We support product launches for:

• Generic pharmaceutical companies
• OTC skin care brands
• Hospital suppliers and government tenders
• NGO and humanitarian healthcare programs
• Dermatology-focused e-commerce platforms

Sustainability and Compliance

BluepillExpress follows a responsible, ethical, and sustainable approach:

• GMP-compliant waste and effluent management systems
• Use of environmentally safe excipients and preservatives
• Recyclable packaging options
• Fair labor practices, equal opportunity employment, and no child labor
• Ethical sourcing of active pharmaceutical ingredients (APIs)

We align with global public health and sustainability goals, offering clean, ethical manufacturing you can trust.

How to Start Manufacturing Fluocinolone Acetonide with BluepillExpress

Step 1: Requirement Sharing

Provide details on product form (cream, oil, lotion, etc.), strength, packaging, and destination country.

Step 2: Quotation & Terms

Receive a detailed commercial quote including MOQ, pricing, timelines, and documentation list.

Step 3: Sample Development (If Required)

We prepare a pilot batch/sample for your evaluation or registration submission.

Step 4: Manufacturing & QA

Full-scale production begins with QA-approved processes and batch-wise documentation.

Step 5: Labeling & Packing

We customize your packaging with regulatory labeling, branding, and inserts.

Step 6: Shipping & Support

We coordinate documentation, customs clearance, and global dispatch.

Conclusion

Fluocinolone Acetonide remains a clinically essential corticosteroid for dermatological and ENT conditions. Its versatility, safety, and efficacy make it a vital addition to pharmaceutical portfolios targeting dermatology, pediatrics, and general medicine.

With expertise in topical steroid manufacturing, flexible private-label options, and full-spectrum regulatory support, BluepillExpress is your trusted third-party manufacturing partner. Whether you’re a startup, a distributor, or a government health agency, we deliver quality, compliance, and cost-efficiency for every order.