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Clobetasol Propionate

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Clobetasol Propionate is one of the most potent topical corticosteroids used in dermatology for the treatment of a wide range of skin conditions involving inflammation, itching, and scaling. With its exceptional anti-inflammatory, anti-pruritic, and vasoconstrictive properties, it plays a vital role in managing dermatological disorders such as psoriasis, eczema, and dermatitis.

As skin care and dermatology markets continue to expand globally, the demand for GMP-certified Clobetasol Propionate products has significantly risen. At BluepillExpress, we offer comprehensive third-party manufacturing of Clobetasol Propionate in various topical forms such as creams, ointments, lotions, gels, and solutions. Our state-of-the-art facilities, regulatory expertise, and commitment to quality ensure that our clients receive safe, effective, and market-ready products suitable for both regulated and semi-regulated markets.

What is Clobetasol Propionate?

Clobetasol Propionate is a synthetic corticosteroid belonging to the class of superpotent (Class I) topical steroids. It is primarily used for the short-term relief of severe skin conditions and works by reducing inflammation and suppressing immune responses in the affected area.

Therapeutic Class: Topical Corticosteroid
Mechanism of Action: Inhibits phospholipase A2, reducing inflammation, erythema, and pruritus
Route of Administration: Topical (external use)

Therapeutic Indications

Clobetasol Propionate is widely prescribed by dermatologists for the treatment of moderate to severe inflammatory skin conditions. It is particularly effective in areas resistant to less potent corticosteroids.

Primary Indications:

  • Psoriasis (especially plaque psoriasis)
  • Eczema and contact dermatitis
  • Lichen planus
  • Discoid lupus erythematosus
  • Seborrheic dermatitis
  • Atopic dermatitis
  • Allergic skin reactions
  • Lichen simplex chronicus
  • Alopecia areata (off-label)

It is commonly used in both adult and pediatric populations under medical supervision, with caution against prolonged or excessive use.

Why Partner with BluepillExpress?

BluepillExpress is a reputed name in pharmaceutical third-party manufacturing, known for superior dermatological product manufacturing, strict compliance with global quality standards, and flexible client-oriented services.

Our Competitive Edge:

  • WHO-GMP, ISO 9001:2015 certified manufacturing units
  • Separate areas for topical semi-solid manufacturing
  • High-speed filling, packaging, and labeling lines
  • Customizable formulations with various base types (cream, ointment, gel, etc.)
  • Regulatory-compliant with IP/BP/USP/EP standards
  • Competitive pricing and low minimum order quantities (MOQs)
  • Full-spectrum private labeling and OEM services
  • Dedicated export and documentation team

We serve a wide range of clients—from emerging skincare brands to large-scale pharmaceutical exporters—ensuring excellence at every level of production.

Available Formulations

We manufacture Clobetasol Propionate in a variety of dosage forms to suit different therapeutic and market needs.

Formulations Offered:

  • Clobetasol Propionate 0.05% Cream
  • Clobetasol Propionate 0.05% Ointment
  • Clobetasol Propionate 0.05% Gel
  • Clobetasol Propionate 0.05% Lotion
  • Clobetasol Propionate 0.05% Scalp Solution

These formulations are available in various pack sizes, including 10g, 15g, 20g, 30g, 50g, and 100g tubes or bottles, depending on regional demand and preferences.

Product Composition

All our Clobetasol Propionate products are formulated using pharmaceutical-grade excipients and APIs with full compliance to global safety and quality benchmarks.

Example: Clobetasol Propionate Cream 0.05%

  • Active Ingredient: Clobetasol Propionate IP/BP/USP 0.05% w/w
  • Base: Aqueous cream base with emulsifying wax, cetostearyl alcohol, white soft paraffin, propylene glycol, and purified water
  • Preservatives: Methylparaben, Propylparaben (optional based on client preference)

We offer paraben-free, fragrance-free, and color-free options upon request.

Manufacturing Process

BluepillExpress follows cGMP-compliant protocols for semi-solid manufacturing, with a dedicated production zone for dermatological preparations.

Key Steps:

  1. API and excipient testing (identity, assay, microbial limits)
  2. Melt and mix base ingredients using jacketed mixers
  3. Incorporate active ingredient at controlled temperatures and mixing speeds
  4. Homogenization for uniform distribution and smooth texture
  5. Filling and sealing in collapsible aluminum or laminate tubes
  6. Visual inspection, batch coding, and secondary packaging
  7. Final quality checks and release

Our processes are validated to ensure uniformity, stability, viscosity, and microbial safety.

Quality Assurance and Control

Every batch of Clobetasol Propionate undergoes strict quality control testing to ensure safety, potency, and performance.

Quality Tests Conducted:

  • Assay and content uniformity
  • pH and viscosity
  • Microbial load (TAMC, TYMC)
  • Sterility (if required)
  • Particle size (for gels and emulsions)
  • Tube/pack integrity and seal test
  • Stability testing (ICH guidelines)

A Certificate of Analysis (COA) accompanies each batch, ensuring full transparency and traceability.

Packaging and Labeling

We provide fully customized packaging solutions tailored to your brand’s visual identity and market requirements.

Packaging Options:

  • Tubes: Aluminum or laminated tubes with tamper-evident nozzles
  • Containers: HDPE or PET bottles for lotions and solutions
  • Cartons: Printed or plain cartons with inserts
  • Labeling: Multilingual, barcode, serialization, and QR code compliant
  • Design: Support for private label artwork, logo placement, and branding

We accommodate white-label, OEM, and institutional packaging as per client specifications.

Regulatory Documentation and Compliance

BluepillExpress offers full regulatory support and product registration assistance for Clobetasol Propionate across global markets.

Documentation Provided:

  • Certificate of Pharmaceutical Product (COPP)
  • WHO-GMP Certificate
  • Product Dossier in CTD or ACTD format
  • Certificate of Analysis (COA)
  • Free Sale Certificate (FSC)
  • Batch Manufacturing Record (BMR)
  • Master Formula Record (MFR)
  • Method of Analysis (MOA)
  • Safety Data Sheet (SDS)
  • Prescribing Information and Label Claims

Our regulatory support ensures speedy approval and seamless market entry.

Export Capability

BluepillExpress is a reliable and experienced exporter of dermatology products, shipping to over 40 countries with a strong logistics and documentation network.

Export Markets:

  • Africa: Kenya, Ghana, Ethiopia, Nigeria, Uganda
  • Middle East: Saudi Arabia, UAE, Iraq, Yemen, Jordan
  • Asia-Pacific: Philippines, Bangladesh, Vietnam, Nepal, Sri Lanka
  • CIS Countries: Uzbekistan, Armenia, Kazakhstan
  • Caribbean & LATAM: Bolivia, Dominican Republic, Peru, Guyana
  • Island Nations: Fiji, Papua New Guinea, Maldives

We ensure air and sea shipments with complete shipping documentation, including commercial invoices, COAs, MSDS, airway bills, and packing lists.

Ideal Clients for Clobetasol Propionate Manufacturing

Our third-party Clobetasol Propionate manufacturing services are perfect for:

  • Dermatology-focused pharmaceutical companies
  • Private label skincare brands
  • Institutional and hospital supply chains
  • Telemedicine and online pharmacy platforms
  • Tender-based government buyers
  • Cosmetic companies with medicated product lines
  • Distributors targeting regulated and emerging markets

Why BluepillExpress?

  • WHO-GMP certified dermatology product manufacturing units
  • Customizable formulation and packaging options
  • Full regulatory and documentation support
  • Competitive pricing with scalable production volumes
  • Proven export logistics and global reach
  • Dedicated client servicing and production tracking
  • Cleanroom conditions with validated semi-solid processes
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