Introduction

Actiza Pharmaceutical is a WHO-GMP certified pharmaceutical exporter supplying Diclofenac Sodium Injection as a sterile finished dosage formulation not API to importers, distributors and hospital procurement bodies across Africa, Southeast Asia, Latin America and the Middle East.

Our 25 mg/ml solution in 3 ml amber ampoules is manufactured in a dedicated sterile injectable block, filled under nitrogen protection and terminally sterilised, then released against sterility, bacterial endotoxin and particulate matter specifications.

Every consignment ships with a complete CTD dossier, also available in ACTD and eCTD format, supported by CoPP, FSC, and ICH Zone IVb stability data so your regulatory team can move directly to MOH registration.

Product Overview

Field	Details
Product Name	Diclofenac Injection
INN / Generic Name	Diclofenac Sodium
Therapeutic Class	Non-steroidal anti-inflammatory drug (NSAID) non-selective COX inhibitor
Indications	Acute pain and inflammation: post-operative pain, renal and biliary colic, acute musculoskeletal conditions, acute exacerbations of arthritis
API Quality	Manufactured using DMF-grade Diclofenac Sodium
Pharmacopoeial Standard	BP / IP Diclofenac Injection BP is the usual export specification
Strength / Concentration	25 mg/ml 3 ml ampoule delivering 75 mg
Dosage Forms	Solution for injection in ampoule; 1 ml presentation and vial pack
Route	Deep intragluteal intramuscular injection; intravenous use requires dilution per approved labelling
Key Excipients	Benzyl alcohol, propylene glycol, sodium metabisulfite, mannitol
Product Type	Sterile Small Volume Parenteral (SVP)
Sterilisation Method	Terminal sterilisation (moist heat)
Shelf Life	24 Months
Storage	Store below 30°C, protected from light. Do not freeze or refrigerate.
Manufacturing Facility	Dedicated sterile injectable block WHO-GMP Certified
Safety Labelling	NSAID cardiovascular and gastrointestinal class warnings; sulfite and benzyl alcohol cautions must appear on artwork
Dossier Available	Yes CTD / ACTD / eCTD format
Regulatory Documents	CoA, CoPP, FSC, MOA, GMP Certificate, Stability Data, Sterility & Endotoxin Reports
Markets Served	Africa, Southeast Asia, LATAM, Middle East, CIS

Product Variants, Dosage Forms & Strengths

Diclofenac Sodium Injection 25 mg/ml – 3 ml Ampoule (75 mg)

The standard global presentation and the format specified in the overwhelming majority of hospital tenders.

Supplied as a clear, sterile solution in amber Type I glass ampoules with a one-point-cut or colour-break ring for clean opening.

Because diclofenac solution is oxygen-sensitive, the filling line runs under nitrogen protection with an antioxidant in the formula this is a formulation and process control point.

Target buyers: hospital procurement, MOH tenders, emergency and surgical departments, wholesale distributors.

Alternative Fill Volumes and Containers

1 ml ampoule presentation, where a lower unit dose is specified by the buyer.

Vial presentation, where multi-dose or preservative-system requirements differ from the ampoule format.

Confirm which of these are actually manufactured a vial format changes the preservative and closure system and therefore the dossier.

Sterility Assurance & Release Testing

Terminal sterilisation by moist heat is the default route for this product, consistent with the regulatory expectation that terminal sterilisation is used wherever the formulation permits it

Sterility tested per USP <71> / Ph. Eur. 2.6.1

Bacterial endotoxins tested per USP <85> (LAL) against a calculated endotoxin limit

Particulate matter tested per USP <788> sub-visible particulates are a standard rejection point for injectables in tender inspection

Container closure integrity demonstrated by dye ingress or equivalent method for the sealed ampoule

Fill volume, pH, clarity and colour verified at release

Regulatory & Dossier Support

Dossier Availability

CTD (Common Technical Document) ICH-aligned, for regulated and semi-regulated markets; ACTD (ASEAN Common Technical Dossier) for Philippines, Vietnam, Myanmar, Indonesia, Cambodia; eCTD for authorities mandating electronic submission.

Module 3 quality documentation covers sterilisation cycle validation with F0 justification, heat penetration and bioburden data, container closure system qualification and nitrogen purging control.

Stability data includes real-time and accelerated under ICH Zone IVb (30°C / 75% RH), plus photostability data supporting the light-protection statement and the amber ampoule.

Bioequivalence: The Parenteral Biowaiver, and Its Conditions

For parenteral solutions, regulators treat bioequivalence (BE) as self-evident under defined conditions rather than requiring an in vivo study.

FDA regulation waives in vivo BE where the product is a parenteral solution intended solely for injection and contains the same active and inactive ingredients in the same concentration as the approved reference product.

EMA guidance takes a comparable position for intramuscular and subcutaneous routes.

The condition that actually decides the outcome is excipient sameness.

Diclofenac injection formulations differ between manufacturers in their preservative, co-solvent, and antioxidant systems so the waiver is conditional in practice.

Our formulation is developed toward qualitative and quantitative (Q1/Q2) alignment with the reference product specifically to keep the waiver route open for our partners.

Where an authority applies additional expectations for aqueous parenteral solutions, comparative physicochemical data, including viscosity, is supplied to demonstrate that excipient differences have no impact on performance.

Practical effect for the buyer: a registration route measured in months rather than one requiring a clinical study.

Drug Master File (DMF)

Drug Master File (DMF) reference for the Diclofenac Sodium API is available for cross-referencing in your registration dossier.

API is sourced from a qualified vendor with full impurity, residual solvent, and elemental impurity characterisation.

CDSCO / Indian DMF reference is accepted by a large number of importing authorities.

Manufacturing Compliance

WHO-GMP certified manufacturing facility, audit-ready, with inspection reports shared on an NDA basis.

Dedicated sterile injectable block with Grade A filling under Grade B background per ISO 14644, HEPA-filtered unidirectional airflow, qualified gowning and routine environmental monitoring.

Sterilisation cycle validated with heat penetration studies, bioburden monitoring before sterilisation, and documented F0 justification terminal sterilisation shifts the assurance from process simulation to a measured lethality value.

Water for Injection system qualified and monitored, with endotoxin and conductivity trending.

Compliant with the requirements of NAFDAC (Nigeria), PPB (Kenya), TFDA (Tanzania), FDA Philippines, and INVIMA (Colombia).

Complete Documentation Package (Per Shipment)

Document	Purpose
Certificate of Analysis (CoA)	Confirms batch quality against the agreed specification
Certificate of Pharmaceutical Product (CoPP / CPP)	Required for MOH registration in most importing countries
Free Sale Certificate (FSC)	Confirms the product is freely sold in the country of manufacture
Method of Analysis (MOA)	Analytical methodology mandatory dossier component
GMP Certificate	Confirms manufacturing site compliance, including the sterile block
Stability Data	Real-time and accelerated ICH Zone IVb, plus photostability
Sterility Test Report	USP <71> / Ph. Eur. 2.6.1 product-critical for a parenteral
Bacterial Endotoxin Report	USP <85> LAL, against the calculated endotoxin limit
Particulate Matter Report	USP <788> sub-visible particulates, a common tender rejection point
Sterilisation Cycle Validation	F0 justification, heat penetration and pre-sterilisation bioburden data
Container Closure Integrity Test (CCIT)	Demonstrates ampoule seal integrity across shelf life
Non-Animal Origin Declaration	Replaces the BSE/TSE declaration confirm excipient origin
Batch Manufacturing Records (BMR)	Available on request, NDA basis

Clinical Indications & Therapeutic Information

Diclofenac sodium is a non-steroidal anti-inflammatory drug (NSAID) and a non-selective inhibitor of cyclo-oxygenase.

The injectable presentation exists for situations where rapid onset is required, or the oral route is unavailable, which is why it sits in emergency, surgical and inpatient formularies.

Principal indications for the injection: post-operative pain, renal and biliary colic, acute musculoskeletal trauma and acute exacerbations of inflammatory arthritis

Administration is by deep intragluteal intramuscular injection; intravenous administration requires dilution and specific handling per approved labelling

NSAID class warnings on cardiovascular thrombotic events and gastrointestinal bleeding, ulceration and perforation apply and must carry through to leaflet and artwork

Formulation-specific cautions: products containing sodium metabisulfite carry a sulfite hypersensitivity warning, and products containing benzyl alcohol carry restrictions on use in neonates

Injection-site reactions are a documented risk of intramuscular NSAID administration

Diclofenac appears on numerous national essential medicines lists and remains a high-volume, low-unit-cost hospital line item

Target Export Markets

Africa: Nigeria, Kenya, Tanzania, Ghana, Uganda, Ethiopia, Zambia, Côte d’Ivoire. Registration support through NAFDAC, PPB, TFDA, FDA Ghana. Hospital and emergency-department demand is steady and largely tender-driven. English and French labelling available.

Southeast Asia: Philippines, Vietnam, Myanmar, Cambodia, Indonesia, Bangladesh. ACTD dossier format supplied as standard. ICH Zone IVb data is a prerequisite, and photostability matters here given ambient light exposure in distribution.

Latin America: Colombia, Peru, Ecuador, Bolivia, Guatemala, Dominican Republic. Spanish and Portuguese labelling available. CTD format with local regulatory adaptation.

Middle East & CIS: Iraq, Yemen, Jordan, Uzbekistan, Kazakhstan, Azerbaijan. GMP Certificate and CoPP are the primary registration requirements. Arabic and Russian labelling available on request.

Export Packaging & Supply Chain

Primary Packaging Options

Presentation	Packaging Options
Diclofenac Injection 25 mg/ml, 3 ml	Amber Type I glass ampoule, one-point-cut; 5 or 10 ampoules per tray in mono-carton with leaflet
Hospital / Tender Supply	Bulk shipper cartons, 100 ampoules per inner carton, with programme overprinting
1 ml ampoule	Amber Type I glass ampoule, pack configuration to be confirmed
Vial presentation	Type I glass vial with bromobutyl stopper and flip-off seal—different closure system

Amber glass is a specification requirement here diclofenac solution is light-sensitive, and the photostability data in the dossier supports the container as registered.

Ampoule tray design also matters: breakage in transit is the most common cause of short-shipment claims on glass ampoules, so we ship in fitted trays with shipper cartons qualified for the route.

Labelling & Customisation

Private label manufacturing with your brand name and artwork, subject to unchanged regulatory content.

Multi-lingual labelling in English, French, Spanish, Portuguese, Arabic, Russian.

Mandatory artwork content: route of administration, dilution instruction for intravenous use, NSAID class warnings, sulfite and benzyl alcohol cautions, storage statement and country-specific registration fields.

Ampoule print must remain legible after autoclaving a routine artwork failure on terminally sterilised products.

Logistics & Supply

Incoterms: FOB, CIF, CFR, EXW as per buyer requirement. No cold chain required, but the product must not be frozen or refrigerated, and must be protected from light and sustained heat in transit.

Experienced in shipping glass ampoules to Africa, CIS, LATAM, and Southeast Asia, including breakage-resistant packing and port-clearance documentation support.

Why Source Diclofenac Injection From Us?

WHO-GMP Certified Sterile Manufacturing Dedicated injectable block with Grade A filling under Grade B background, qualified Water for Injection system and continuous environmental monitoring.

Terminally Sterilised, With the Data to Prove It Validated moist-heat cycle with documented F0, heat penetration, and pre-sterilisation bioburden data.

Parenteral Biowaiver Route Kept Open We formulate toward Q1/Q2 alignment with the reference product so the in-vivo bioequivalence waiver remains available.

Complete Dossier CTD, ACTD and eCTD dossiers pre-compiled, with regulatory query response support included.

Tender-Ready Documentation Sterility, bacterial endotoxin and particulate matter reports supplied per batch.

End-to-End Regulatory Support From CoA to CoPP to FSC, all export documentation handled in-house.

Frequently Asked Questions

Ready to Source Diclofenac Injection FDF?

Share your target market, pack requirement, and annual volume, and our export team will respond with the applicable specification, dossier format, pack options, and pricing.

If you are preparing a tender submission, request the dossier summary, sterilisation validation abstract, and a sample CoA first no commitment required.