Azelaic Acid Cream 15% – Dermatologist Recommended Solution for Clear, Healthy Skin

Introduction
Azelaic Acid Cream 15% is an FDA-approved topical formulation widely used in dermatology for the treatment of acne vulgaris, rosacea, and hyperpigmentation disorders. Manufactured under WHO-GMP, cGMP, EU-GMP, and PIC/S-certified facilities at Taj Pharma India Ltd., this cream combines scientific efficacy, safety, and global regulatory compliance, making it a trusted option for clinicians and patients across international markets.

Composition & Therapeutic Category

• Active Ingredient: Azelaic Acid 15% w/w
• Excipients: Purified Water, Propylene Glycol, Benzoic Acid, Isopropyl Myristate, Glycerol, Polysorbates, Carbomers (optimized for dermal absorption and stability).
• Therapeutic Category:
  • Anti-Acne Agent
  • Anti-Rosacea Agent
  • Skin Depigmenting Agent

FDA-Approved Clinical Benefits & Uses

✔ Reduces inflammatory lesions in mild to moderate acne vulgaris
✔ Treats rosacea by decreasing swelling, redness, and bumps
✔ Lightens post-inflammatory hyperpigmentation & melasma
✔ Improves skin texture & tone with continued use
✔ Non-comedogenic, safe for long-term dermatological therapy

Manufacturing Process (Q & Q + Flowchart)

Machinery Used

• Stainless Steel Mixing Vessel with heating & cooling jacket
• High Shear Homogenizer for emulsification
• Vacuum Planetary Mixer (removes air, ensures smooth texture)
• Tube Filling & Sealing Machine (for 20 g laminated/aluminum tubes)
• Automatic Labeling & Cartoning Line

Q & Q (Quantity & Quality)

• R&D Batch Size: 1 kg – 5 kg (lab trials)
• Commercial Batch Size: 100 kg – 500 kg
• In-process Controls: pH (4.8–5.5), viscosity, assay (95–105%), microbial limits, stability

Manufacturing Flow

1. Dispensing of raw materials (QMS-based weighing)
2. Aqueous Phase Preparation (dissolution of stabilizers, preservatives)
3. Oil Phase Preparation (lipid excipients)
4. Emulsification & Homogenization (Azelaic acid dispersed evenly)
5. Cooling under Vacuum (air-free smooth cream)
6. Filling into Tubes (20 g each, sealed & batch coded)
7. Secondary Packing (carton, foil, patient leaflet)
8. QC Testing & Batch Release (COA + FDA approved specs)

FDA Caution & Safety Label

• Schedule H Prescription Drug – To be sold by retail on the prescription of a dermatologist only.
• For external use only. Avoid contact with eyes, mouth, and mucous membranes.
• Store below 25°C, protect from light & moisture.
• Keep out of reach of children.

Packaging & Commercial Supply

• Primary Pack: 20 g laminated/aluminum tube with HDPE cap
• Secondary Pack: Printed carton with FDA-approved label + patient leaflet
• Bulk Export Options:
  • Taj Pharma brand supply
  • Private Label / CMO contract manufacturing
  • Customized formulation with vitamins (C, E, Niacinamide) for added antioxidant benefits

Global Export & Distribution

Taj Pharma India Ltd. is a leading global supplier of Azelaic Acid Cream 15% with regulatory filings across:

• PIC/S Countries – Singapore, Malaysia, South Africa, Switzerland
• Latin America – Brazil, Mexico, Peru, Chile
• Middle East & Africa – UAE, Saudi Arabia, Kenya, Nigeria
• Asia & CIS – Vietnam, Philippines, Kazakhstan, Russia
• European Market – Dossier-ready, CTD/ACTD compliance

We invite pharmaceutical distributors, dermatology clinics, hospital pharmacies, and merchant exporters to collaborate for commercial supply, co-branding, and long-term distribution partnerships.

Why Choose Taj Pharma?

• FDA-approved manufacturing process
• Global dossier support (CTD/ACTD/DMF-ready)
• Flexible packing: Taj Pharma brand / OEM / Private Label
• Worldwide distribution expertise (exports to 50+ countries)
• High-capacity WHO-cGMP certified Sarigam facility

For More Info:

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

What’s App: +91-7861865490

Toll Free No: 1800-222-825