Suppliers and packagers for generic pharmaceutical drug: DICLOFENAC SODIUM

DICLOFENAC SODIUM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actavis Mid Atlantic	DICLOFENAC SODIUM	diclofenac sodium	GEL;TOPICAL	206493	ANDA	Actavis Pharma, Inc.	0472-1783-10	1 TUBE in 1 CARTON (0472-1783-10) / 100 g in 1 TUBE	2016-05-19
Actavis Mid Atlantic	DICLOFENAC SODIUM	diclofenac sodium	GEL;TOPICAL	206493	ANDA	Proficient Rx LP	71205-752-00	1 TUBE in 1 CARTON (71205-752-00) / 100 g in 1 TUBE	2016-05-19
Actavis Mid Atlantic	DICLOFENAC SODIUM	diclofenac sodium	GEL;TOPICAL	206493	ANDA	Asclemed USA, Inc.	76420-261-01	1 TUBE in 1 CARTON (76420-261-01) / 100 g in 1 TUBE	2016-05-19
Alembic	DICLOFENAC SODIUM	diclofenac sodium	GEL;TOPICAL	212351	ANDA	Medsource Pharmaceuticals	45865-260-01	100 g in 1 TUBE (45865-260-01)	2022-09-15

Diclofenac Sodium Drug: Supplier Map and Supply-Chain Considerations

Last updated: April 23, 2026

Diclofenac sodium is a widely manufactured, commodity-style API and solid-dose drug product. Supplier coverage typically spans (1) API manufacturers, (2) intermediates and API packagers, and (3) finished-dose generic brands sold by distributors and wholesalers. Supply is usually robust for legacy strengths and dosage forms, with tighter constraints when a customer needs specific polymorphs, particle-size targets, DMF/CEP status, or controlled sourcing for injectables.

What types of suppliers support diclofenac sodium supply?

API manufacturers

Companies that produce diclofenac sodium (active pharmaceutical ingredient) for downstream formulation. These suppliers provide:

• API bulk material (often in drums/IBC)
• Quality documentation packages aligned to customer requirements (typical examples include CoA, GMP certificates, DMF references, and/or CEPs where applicable)
• Controlled specs on assay, impurities, water content, residual solvents, and particle-size targets (when specified)

Intermediates and API packagers

Firms that do not always synthesize the final API themselves but support supply through:

• Intermediate production and onward conversion to API (in integrated supply chains)
• Re-packaging, relabeling, or finishing to meet customer logistics and documentation needs

Finished-dose drug product manufacturers (generics)

Companies that formulate and manufacture tablets, capsules, gels, or other dosage forms using diclofenac sodium API. These suppliers provide:

• Finished-dose manufacturing, packaging, and labeling
• Regulatory dossier linkage (varies by market)
• Formulation-specific performance attributes (release profiles, stability, moisture uptake controls)

Which supplier categories dominate diclofenac sodium sourcing?

Commercial API

Diclofenac sodium is typically sourced from multiple approved and qualified API vendors for continuity of supply. Customer procurement often uses:

• Multi-vendor qualification strategies
• Regional distributor layers for lead-time control
• Spec-driven selection (particle size, impurity profile, and polymorphic form targets when required)

Injectables and niche dosage forms

When sourcing extends beyond oral solids into injectables or specialized topical formats, supplier selection tightens because:

• Sterility assurance and container-closure requirements vary by site
• Validation documentation expectations are higher
• Lead times and batch consistency expectations increase

What supplier due-diligence checkpoints matter for diclofenac sodium?

Procurement teams usually score diclofenac sodium suppliers on the same high-impact quality and supply criteria:

Quality system and documentation package

• GMP compliance and inspection history (customer audits or reliance pathways)
• CoA and batch record availability (assay, impurities, residual solvents, water content)
• Regulatory readiness: DMF cross-reference or CEP availability where relevant

Material specifications that affect downstream formulation

Common spec drivers buyers lock down in purchase agreements:

• Assay and related substances (impurities profile)
• Residual solvents and heavy metals limits
• Particle-size distribution (especially for blend uniformity and dissolution)
• Water content and stability under humidity

Supply reliability

Key operational checkpoints:

• Capacity and ability to run at required batch sizes
• Forecasting and lead-time performance
• Traceability and change control discipline (site, process, raw material changes)

How suppliers are typically structured by market route

North America and EU

Finished-dose supply often comes from:

• Generic manufacturers with established dossier strategies
• Distributor networks that source from multiple API sources to ensure continuity

API sourcing in these markets may require:

• Strong documentation (DMF access or equivalent)
• Proven audit trails and change-control transparency

ROW (rest of world)

Supplier networks frequently include:

• Local distributors for faster fulfillment
• API and finished-dose options with varying regulatory alignment depending on importing pathway

Supplier shortlist framework (actionable for procurement teams)

Because diclofenac sodium is widely available, sourcing decisions usually come down to documentation fit and spec compliance rather than brand exclusivity. A practical procurement shortlisting approach:

1. Qualify 2 to 4 API sources that can meet the exact impurity spec and particle-size target needed by the finished-dose process.
2. Qualify at least 1 secondary source that can substitute during outages without requalification burden (same grade, same spec window, compatible regulatory package).
3. Require change-control notifications for site/process changes that can affect impurity profile or physical form.
4. Lock packaging and logistics requirements (drum/IBC type, temperature and humidity handling, shelf-life labeling) in the purchase order.

What should buyers demand in supplier contracts for diclofenac sodium?

Spec and change control

• Defined impurity thresholds and test methods
• Residual solvent and water content limits
• Particle-size or sieve distribution limits where relevant
• Explicit notification timelines for process or raw material changes
• Right to review CoA and batch traceability for every shipment

Quality agreements

• Audit rights or reliance pathways
• Deviation handling and CAPA reporting
• Recalls and complaint-handling SLAs

Commercial continuity

• Minimum order quantities and buffer stock terms
• Lead-time commitments and forecast adherence
• Supply allocation terms during capacity constraints

How to evaluate supplier strength beyond price

For diclofenac sodium, low unit price can be misleading if the supplier creates downstream rejects, reblend needs, or stability issues. Buyers generally prioritize:

• Lower variability in impurity profile across batches
• Stable particle-size and bulk density for consistent formulation
• Reliable CoA turnaround time
• Document readiness aligned with regulatory needs

Key Takeaways

• Diclofenac sodium sourcing spans API manufacturers, API packagers, and finished-dose generic manufacturers, with supply usually robust for standard oral strengths.
• Procurement differentiates suppliers through impurity profile control, particle-size targets, documentation readiness (DMF/CEP pathways), and change-control discipline.
• For higher-risk dosage forms (injectables and specialized topical formats), supplier qualification tightens due to sterility, container-closure, and stability validation expectations.
• A multi-vendor qualification strategy is typically the lowest-risk approach for continuity.

FAQs

1) What is the most common supplier model for diclofenac sodium?

API suppliers plus finished-dose generic manufacturers in multi-sourced procurement structures.

2) Do suppliers usually differ materially in diclofenac sodium API pricing?

Unit pricing varies, but batch-to-batch quality consistency and documentation fit often drive total cost of ownership more than the headline API price.

3) What API specifications most affect downstream formulation performance?

Impurities (related substances), residual solvents, water content, and particle-size distribution.

4) When does supplier selection become more difficult for diclofenac sodium?

When the target dosage form is injectables or specialized topical formats requiring higher assurance for sterility, stability, and release behavior.

5) What documentation should buyers lock into diclofenac sodium supply agreements?

CoA per batch, GMP and regulatory dossier linkage (DMF/CEP pathways where relevant), test methods for critical attributes, and change-control notification terms.

References

[1] European Medicines Agency. (n.d.). CEP and related regulatory information (databases and procedures). EMA. https://www.ema.europa.eu/
[2] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMF) and related guidance. FDA. https://www.fda.gov/
[3] World Health Organization. (n.d.). Guidelines on quality assurance of pharmaceuticals and APIs. WHO. https://www.who.int/