Product Profile

Diclofenac Diethylamine + Thiocolchicoside Gel is a dual-action topical formulation combining NSAID anti-inflammatory action with muscle relaxation for comprehensive musculoskeletal pain relief. As a premier WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech produces this gel using controlled homogenization to ensure uniform API dispersion and consistent percutaneous delivery.

Manufacturing Advantage

Why Saar Biotech for Diclofenac + Thiocolchicoside Gel?

Since 2005, Saar Biotech has been a distinguished WHO-GMP certified leader in pharmaceutical manufacturing. We utilize advanced micronization and pH-stabilization protocols to deliver unmatched bioavailability for this Diclofenac + Thiocolchicoside Gel formulation.

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

Batch Lead Time 30-45 Days (Domestic)
B2B Services Contract & Third-Party
Compliance DCGI & Schedule M Standards
Medical Intelligence

Clinical Q&A for Diclofenac + Thiocolchicoside Gel

Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.

What are the clinical indications for Diclofenac + Thiocolchicoside Gel?

This combination gel is indicated for the topical relief of musculoskeletal pain, muscle spasms, and inflammation associated with conditions such as osteoarthritis, rheumatoid arthritis, sprains, strains, and backache. Diclofenac provides NSAID-mediated anti-inflammatory action, while Thiocolchicoside acts as a muscle relaxant, reducing muscle spasm and promoting mobility.

How does Thiocolchicoside contribute to muscle relaxation?

Thiocolchicoside is a semi-synthetic colchicine derivative that acts as a competitive antagonist at GABA-A receptors in the spinal cord, reducing muscle hypertonia and spasm. It does not have the significant systemic toxicity associated with colchicine and is effective at low concentrations. When combined with Diclofenac, it provides both pain relief and muscle relaxation.

What is the standard application protocol?

A thin layer should be applied to the affected area 2 to 4 times daily as directed by a physician. The gel should be gently massaged into the skin until absorbed. It is for external use only and should not be applied to broken skin, wounds, or mucous membranes.

What are the key contraindications and precautions?

This gel is contraindicated in patients with known hypersensitivity to diclofenac, thiocolchicoside, or any component. It should not be applied to broken skin or open wounds. Use during the last trimester of pregnancy is contraindicated. Caution is advised in patients with a history of gastrointestinal ulceration or bleeding disorders.

What are the common side effects?

Common side effects include transient skin irritation, redness, and burning sensation at the application site. These are typically mild and transient. Contact dermatitis may occur in sensitive patients.
Manufacturing Support

B2B Manufacturing Guide for Diclofenac + Thiocolchicoside Gel

Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.

What tube sizes and packaging formats are available for Diclofenac + Thiocolchicoside Gel?
Saar Biotech manufactures this combination gel in 30 gm and 50 gm laminated tube formats. All tubes are supplied with custom-printed label and mono-carton artwork compliant with DCGI and Schedule M labelling requirements. Packaging options include flap cartons, drip-off brand embossed cartons, and metallic cartons for premium brand positioning.
What is the MOQ for this gel?
Standard MOQ ranges from 5,000 to 10,000 tubes per SKU, depending on tube size and packaging specification. For new pharma brands entering the orthopaedic pain segment, we offer flexible entry-level volumes.
What analytical tests are conducted on every batch?
Every batch undergoes HPLC Assay for Diclofenac Diethylamine, Thiocolchicoside, and Menthol confirming 100% label claim accuracy. pH testing, viscosity measurement, and Microbial Limit Testing (MLT) confirm product quality. A complete Certificate of Analysis (COA) is provided.
Does Saar Biotech support DCGI brand registration for Diclofenac + Thiocolchicoside Gel?
Yes. Saar Biotech’s regulatory team handles DCGI brand name search, product registration, and artwork compliance for topical muscle relaxant and analgesic gels. We ensure all Schedule M labelling requirements and combination drug disclosure standards are met, reducing the compliance burden for our contract manufacturing partners.
What is the turnaround time for a Diclofenac + Thiocolchicoside Gel order?
New manufacturing orders are typically dispatched from our Baddi facility within 30 to 45 working days of artwork finalisation. Repeat commercial orders from established partners are fulfilled within 20 to 25 working days, ensuring consistent product availability for their brands.
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