Product Overview

Diclofenac Gel is a topical non-steroidal anti-inflammatory (NSAID) formulation used in the management of localized musculoskeletal pain and inflammation.

Actiza Pharmaceutical manufactures and exports Diclofenac Gel from a WHO-GMP certified facility in India, supplying pharmaceutical importers, distributors, and procurement teams across international markets.

The product is available as Diclofenac Diethylamine 1.16% w/w equivalent to Diclofenac Sodium 1% w/w in laminated tube packaging of 30g, 50g, and 100g.

The formulation is export-ready with complete regulatory documentation and is supplied for commercial, bulk, and tender requirements.

Our global supply capability supports buyers across regulated and semi-regulated pharmaceutical markets, offering consistent formulation quality, reliable production capacity, and full documentation support for product registration and customs compliance.

Product Specifications

Parameter	Details
Generic Name	Diclofenac Diethylamine
Therapeutic Equivalent	Equivalent to Diclofenac Sodium 1% w/w
Dosage Form	Topical Gel
Available Strengths	1.16% w/w Diclofenac Diethylamine (equivalent to Diclofenac Sodium 1% w/w)
Packaging	Laminated Tubes 30g, 50g, 100g
Shelf Life	24 months
Storage Condition	Store below 30°C, away from heat and direct sunlight
MOQ	On inquiry

Therapeutic Applications

Diclofenac Gel is clinically indicated in the management of localized musculoskeletal pain and inflammation.

It is applied in the treatment of osteoarthritis affecting accessible joints including the knee and hand as well as soft tissue injuries, sprains, strains, and periarticular conditions.

The topical formulation is used across outpatient, physiotherapy, and rheumatology settings, where localized drug delivery is preferred to minimize the systemic exposure associated with oral NSAID therapy.

It is also used in post-trauma and post-operative pain management protocols in institutional healthcare settings.

Product Advantages

Our Diclofenac Gel is formulated to stay stable across a wide range of conditions. This makes it suitable for export to markets with varied temperature and humidity.

The gel base ensures uniform drug dispersion and consistent application characteristics across production batches, which is important for product acceptability in both retail and institutional supply settings.

The laminated tube packaging maintains product integrity throughout the distribution chain, preventing contamination and preserving formulation stability during transit and storage.

With a 24-month shelf life, the product supports effective inventory planning for distributors and institutional buyers managing multi-market supply chains.

Flexibility in tube size 30g, 50g, and 100g allows the product to be positioned across retail pharmacy, hospital dispensary, and bulk institutional supply channels without reformulation or repackaging complexity.

Manufacturing & Quality Standards

We manufacture Diclofenac Gel at our WHO-GMP certified facility in India.

In-process quality controls are applied at each production stage, from raw material dispensing and gel preparation through to tube filling, sealing, and secondary packaging.

Each batch is subject to comprehensive finished product testing including assay, identification, pH, viscosity, homogeneity, microbial limits, and packaging integrity verification before release for distribution.

Batch-to-batch consistency is maintained through validated manufacturing procedures and a documented quality assurance system, ensuring that every shipment meets the product specifications established at registration.

Complete batch manufacturing records are maintained and are available for regulatory review.

Our quality control laboratory operates with calibrated instruments and follows pharmacopoeial testing methods, ensuring that finished formulation production consistently meets the quality standards required for export to international pharmaceutical markets.

Regulatory & Export Support

We provide complete export and regulatory documentation to support importers and distributors in their market registration, product licensing, and customs clearance processes.

Standard export documentation includes Certificate of Analysis (COA), Certificate of Origin (COO), and Material Safety Data Sheet (MSDS).

A GMP certificate issued by the relevant Indian regulatory authority is available for submission to importing country regulatory bodies.

Product dossiers in CTD format are available upon request to support product registration in applicable markets, including ICH-compliant stability data to meet regulatory submission requirements.

Our dedicated regulatory support team assists importers in coordinating documentation requirements across multiple international markets, reducing registration timelines and administrative burden for buyers managing multi-country pharmaceutical portfolios.

The team is experienced in supporting product registration across regulated and semi-regulated markets in Africa, Asia, the Middle East, and Latin America.

Packaging & Supply Capabilities

Diclofenac Gel is available for commercial supply in retail-ready laminated tube packaging 30g, 50g, and 100g as well as in bulk supply configurations suitable for institutional procurement and tender requirements.

Private label manufacturing and white label supply are supported, enabling distributors and pharmaceutical companies to market the product under their own registered brand in licensed territories.

we support contract manufacturing arrangements for pharmaceutical companies requiring additional topical formulation production capacity.

Supply formats include commercial supply, bulk supply, and tender supply, with minimum order quantities and delivery lead times discussed based on destination market and order volume.

Why Source from Actiza Pharmaceutical Pvt. Ltd.

Actiza Pharmaceutical Pvt. Ltd. is anestablished Indian pharmaceutical manufacturer and exporter with experience supplying finished formulations to importers and distributors across Africa, Asia, the Middle East, and Latin America.

The company operates from a WHO-GMP-certified manufacturing facility with the production capacity to fulfil both long-term commercial supply agreements and tender-based procurement requirements.

Our dedicated export team manages complete regulatory documentation and shipping coordination, ensuring smooth customs clearance and minimal lead time disruption for international buyers.

Competitive pricing, reliable production capacity, and documented quality assurance processes make us a dependable supply partner for distributors managing multi-product pharmaceutical portfolios.

Private label, white label, and contract manufacturing options provide buyers with the supply flexibility needed to support their own product registration and distribution requirements across target markets.

Request a Quote or Product Information

Pharmaceutical importers, distributors, and procurement teams can submit a product inquiry to receive pricing, availability, and regulatory documentation for Diclofenac Gel.

Documentation including a Certificate of Analysis, GMP certificate, and CTD product dossier is available on request.

Contact us to discuss supply terms, packaging options, and private label or contract manufacturing arrangements.

Frequently Asked Questions