Clindamycin + Nicotinamide Gel
Clindamycin Phosphate IP 1% w/w + Nicotinamide IP 4% w/w Gel · Dermatology, Antibiotics, Skin Care
GEL PRESENTATION:
Product Profile
Clindamycin Phosphate + Nicotinamide Gel is a clinically proven, dual-action topical formulation for the effective treatment of acne vulgaris. As a premier WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech produces this gel using controlled homogenization to ensure uniform API dispersion, consistent viscosity, and stable percutaneous delivery across every batch.
DCGI Approved
Comprehensive documentation and CDSCO support for rapid market entry in India.
Fast Turnaround
30-45 days lead time for new batches with state-of-the-art logistics.
Pan-India Supply & Contract Manufacturing
Clinical Overview & Therapeutic Class
Clindamycin + Nicotinamide Gel belongs to the Gels category and is classified as a topical antibiotic and anti-inflammatory preparation.
- Clindamycin Phosphate 1% — antibiotic that inhibits bacterial protein synthesis, reducing P. acnes growth
- Nicotinamide 4% — anti-inflammatory agent that reduces redness and inflammation
Saar Biotech manufactures DCGI-approved formulations of this combination gel from our manufacturing facility in Baddi, available in 10gm, 15gm, 20gm, and 30gm laminated tube formats.
Pan-India Supply & Contract Manufacturing
The Saar Biotech Advantage
At Saar Biotech, we manufacture Clindamycin + Nicotinamide Gel using a precision-controlled homogenization process that ensures every tube delivers uniform API distribution, consistent sensory performance, and stable shelf-life potency.
- Two-API Uniformity: Homogeneous dispersion of both actives is achieved through validated mixing sequence.
- Viscosity Consistency: Every batch is tested for viscosity to ensure the gel spreads easily and maintains correct texture.
- pH-Optimised Base: The gel base is formulated and verified within a skin-compatible pH range.
- Tube Filling Precision: Automated laminated tube filling lines ensure accurate fill weight per tube.
Pan-India Supply & Contract Manufacturing
Key Indications & Usage
Clindamycin + Nicotinamide Gel is manufactured by Saar Biotech for the following clinically recognised indications:
- Acne Vulgaris: Treatment of inflammatory acne lesions
- Acne Management: Effective for mild to moderate acne
- Inflammatory Skin Conditions: Reduction of redness and inflammation
Pan-India Supply & Contract Manufacturing
Mechanism of Action & Formulation Integrity
Clindamycin Phosphate is a lincosamide antibiotic that binds to the 50S ribosomal subunit of bacteria, inhibiting protein synthesis and reducing Propionibacterium acnes growth. Nicotinamide reduces inflammation by inhibiting cytokine release and decreasing neutrophil chemotaxis.
Manufacturing Integrity
- Chemical Stability: Both actives remain chemically stable in the gel base.
- Preservation System: The gel includes a validated preservation system.
Pan-India Supply & Contract Manufacturing
B2B & Contract Manufacturing Details
Saar Biotech offers specialised Contract Manufacturing (CMO) and Third-Party Manufacturing services for Clindamycin + Nicotinamide Gel from our semi-solid manufacturing facility in Baddi, Himachal Pradesh.
- Facility: Dedicated semi-solid manufacturing lines with planetary mixer homogenizers and automated laminated tube filling and sealing equipment.
- Capacity: Pilot batches from 5,000 tubes to commercial runs of 1,00,000+ tubes.
- Quality Lab: GLP-certified in-house QC with HPLC, pH metres, viscometers, and stability chambers.
- Turnaround: 30–45 working days for new orders; 20–25 working days for established repeat partners.
- Packaging: 10gm, 15gm, 20gm, and 30gm laminated aluminium tubes with custom mono-carton and label design.
- Regulatory: DCGI-compliant; full COA, batch records, and stability data provided.
- MOQ: 5,000–10,000 tubes per SKU.
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Storage & Handling Guidelines
- Sealed Tube Storage: Store below 30°C in a cool, dry location away from direct sunlight and heat sources. Do not freeze.
- In-Use Handling: Replace the cap firmly after each use.
- Application Precautions: Apply exclusively to intact skin. Keep away from eyes, mucous membranes, and broken skin.
Pan-India Supply & Contract Manufacturing
Quality Control & Compliance
Every batch is released only after completing the following analytical protocol:
- HPLC Assay (Two-API): Individual assay of Clindamycin Phosphate and Nicotinamide.
- pH Testing: Verification of pH within skin-compatible specification range.
- Viscosity Testing: Measurement of gel viscosity confirming batch-to-batch consistency.
- Microbial Limit Test (MLT): Confirms total aerobic count and absence of specified pathogens.
- Certificate of Analysis (COA): Issued with every B2B consignment.
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Side Effects & Safety Profile
Common Side Effects: Local irritation, redness, dryness, peeling, and burning sensation.
Contraindications: Known hypersensitivity to any component. Not for use on broken skin, open wounds, or mucous membranes.
Precautions: Avoid contact with eyes. Use during pregnancy and lactation only under physician supervision.
For B2B manufacturing enquiries, third-party contracts, or to request complete product details for Clindamycin + Nicotinamide Gel, please use the enquiry form below.
Pan-India Supply & Contract Manufacturing
Clinical Q&A for Clindamycin + Nicotinamide Gel
Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.
What are the clinical indications for Clindamycin + Nicotinamide Gel?
How does this combination work?
What is the standard application protocol?
What are the key contraindications and precautions?
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B2B Manufacturing Guide for Clindamycin + Nicotinamide Gel
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.