🧴 Composition

  • Active Ingredient: Terbinafine Hydrochloride – 1% w/w
  • Excipients: Emulsifying base, purified water, stabilizers, preservatives, and skin-friendly emollients.

📦 Packing Information

  • Primary pack: Aluminium collapsible tube with tamper-proof cap (15g, 20g, 30g, 50g options)
  • Secondary pack: Printed carton with leaflet (FDA/Schedule H compliant)
  • Bulk packaging available for export tenders & contract manufacturing

⚙️ Manufacturing Process (Taj Pharma Sarigam, India)

  1. Weighing & Dispensing: Ingredients weighed under QMS-controlled environment.
  2. Phase Mixing: Base and emulsifiers homogenized under controlled temperature.
  3. API Addition: Terbinafine HCl incorporated into cream base under sterile conditions.
  4. Homogenization: Ensures uniform dispersion, pH balance, and smooth texture.
  5. Filling & Sealing: Tubes filled under laminar airflow, sealed, and batch coded.
  6. Quality Control: In-process and final product checks (assay, pH, viscosity, microbiology).

🔍 Quality & Quantity (Q & Q)

  • Batch Size: 100 kg (trial/commercial scale)
  • In-process checks: Weight variation, homogeneity, microbial limits
  • Finished product COA: API assay, uniformity, viscosity, pH 5.0–6.0, absence of pathogens

💊 Therapeutic Benefits

  • Effective against dermatophytes, yeast, and mold infections.
  • Used for Athlete’s foot, Ringworm, Jock itch, and Candidiasis.
  • Quick relief from itching, redness, scaling, and burning.
  • Clinically proven with high cure rates vs. standard antifungals.

⚠️ Caution & Safety Information

  • For external use only
  • Avoid contact with eyes, mouth, or broken skin
  • Keep out of reach of children
  • Contraindicated in hypersensitivity to Terbinafine or excipients
  • Store below 25°C in a cool, dry place

🌐 Export Tenders & Distributor Invitation

Taj Pharma invites global distributors, government procurement agencies, and tender authorities to collaborate on WHO-GMP certified Terbinafine HCl 1% Cream.

  • ✅ WHO-cGMP, EU-GMP, ISO certified facility
  • ✅ Ready dossiers (CTD/ACTD) for regulatory submissions
  • ✅ Private label / Contract manufacturing available
  • ✅ Competitive pricing for bulk tenders

🏷️ Contract Manufacturing Label Draft (FDA-Compliant)

  • Brand/Generic Name: Terbinafine Hydrochloride Cream USP, 1%
  • Strength: 1% w/w
  • Net Weight: 30g
  • For Dermatological Use Only
  • Rx Only

Schedule H Drug – To be sold by retail on the prescription of a registered medical practitioner only

Each gram contains: Terbinafine Hydrochloride 10 mg in a cream base

Storage: Store below 25°C. Do not freeze.

Dosage: Apply thin film once or twice daily as directed by physician

Warnings: For external use only. Avoid contact with eyes.

Terbinafine HCl 1% Cream by Taj Pharma is a fast-acting antifungal treatment trusted by doctors worldwide. It provides relief from itching, redness, and scaling caused by fungal skin infections like athlete’s foot, ringworm, and jock itch. The cream is safe, effective, and formulated under strict WHO-GMP standards to ensure the highest quality.

If you are a distributor, healthcare provider, or tender procurement officer, Taj Pharma offers bulk supply, private labeling, and international export support. Patients can be assured of safe, reliable, and effective treatment.

📩 For collaboration, tenders, or government tie-ups in Timor-Leste, contact:
✉️ Sales@tajpharmaindia.com / info@tajpharma.com

What's App: +91- 7861865490 / Direct line: +91 8448 444 095