Introduction

Adapalene 0.1% Cream is a topical retinoid derivative of naphthoic acid, widely prescribed for the treatment of acne vulgaris. As an FDA-approved formulation, it helps regulate skin cell turnover, reduces inflammation, and prevents clogged pores. Taj Pharma manufactures Adapalene Cream under stringent WHO-GMP & FDA-compliant processes, ensuring global quality standards.

✅ Composition

  • Active Ingredient: Adapalene 0.1% w/w
  • Base/Cream Excipients: Purified water, carbomer, propylene glycol, glycerin, PEG, disodium edetate, methylparaben, propylparaben, sodium hydroxide.

🏭 Manufacturing Process (FDA-Approved GMP)

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Q & Q (Quantity & Quality)

  • Batch Size: As per demand (e.g., 100 kg bulk = 5000 tubes of 20 g each).
  • Quality Checkpoints: pH, viscosity, microbial load, assay, uniformity, packaging integrity.

Machinery & Flow

  1. Raw Material Dispensing – Precision weighing (Electronic Balances, GMP area).
  2. Mixing Vessel (Stainless Steel, Jacketed with stirrer) – Heating & uniform dispersion.
  3. Homogenizer – Ensures fine particle distribution & smooth cream texture.
  4. Inline Filtration System – Removes impurities, ensures sterile quality.
  5. Filling & Sealing Machine (20 g Tubes) – Automatic filling in Alu/laminated tubes.
  6. Cartoning & Packing Line – Tube packed in cartons with leaflet, batch printing.
  7. Final QC & Release – As per pharmacopeial & FDA guidelines.

🌟 Benefits & Uses

  • Effective in mild to moderate acne.
  • Helps unclog pores & prevent blackheads/whiteheads.
  • Reduces skin inflammation & redness.
  • Promotes healthier cell turnover.
  • Safe for long-term dermatological use under medical supervision.

💊 Therapeutic Category

  • Dermatology (Topical Retinoid / Anti-Acne Agent)

⚠️ FDA Caution / Label Requirement

  • Schedule H Prescription Drug – Caution
    “To be sold by retail on the prescription of a Registered Medical Practitioner only.”
  • Avoid contact with eyes, mouth, mucous membranes.
  • Not recommended during pregnancy without physician advice.
  • Store below 25°C, away from direct sunlight.

📌 Contact for Manufacturing & Export

E-mail: Sales@tajpharmaindia.com / info@tajpharma.com

Contact: +91- 7861865490 (What’s App)

Toll Free No: 1800-222-825