Suppliers and packagers for dyclopro

dyclopro

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Septodont	DYCLOPRO	dyclonine hydrochloride	SOLUTION;TOPICAL	200480	ANDA	Septodont Inc	0362-3971-05	1 BOTTLE in 1 BOTTLE (0362-3971-05) / 30 mL in 1 BOTTLE	2019-09-01

DYCLOPRO (diclofenac) — Supplier Landscape for Drug Product and Key Intermediates

Last updated: May 4, 2026

What is DYCLOPRO and what supply chain does it imply?

DYCLOPRO is a branded form of diclofenac (API: diclofenac; multiple marketed dosage forms exist globally). Because diclofenac is a mature generic API, the supply chain typically splits into:

• API suppliers (diclofenac base and/or diclofenac sodium)
• Drug product manufacturers (tablets, capsules, gels/creams, injections, patches depending on market)
• Packaging and labeling vendors tied to local regulatory release

The supplier set changes by country, formulation, and whether the product uses diclofenac sodium vs diclofenac free acid, but the API and drug product tiers are consistent.

Who supplies diclofenac APIs used for DYCLOPRO-type products?

The diclofenac API market is served by large generic chemical manufacturers and regional API specialists. In practical procurement, buyers source diclofenac from at least two types of vendors:

• API manufacturers supplying diclofenac sodium or diclofenac (depending on the formulation)
• API distributors that aggregate multiple manufacturers for faster lead times

Market pattern (maturity-driven): diclofenac is widely traded with high supplier redundancy. The dominant differentiators between suppliers are DMF status, inspection history, particle specs, impurity profile, and supply continuity.

Which contract manufacturers typically build diclofenac drug products?

For diclofenac-branded products, CDMOs commonly cover:

• Solid oral dosage: tablets and capsules (compression/granulation or direct compression, depending on strength and excipient system)
• Topicals: gels and creams (rheology control, spreading performance, container compatibility)
• Parenterals: injectable forms (sterile manufacturing, if the specific DYCLOPRO market uses injections)

Drug product sourcing is driven by:

• GMP footprint for the dosage form
• Ability to match local in-spec dissolution and impurity targets
• Packaging line compatibility (blister, strip, bottle, tube, ampoule, sachet)

How to map “supplier” to actionable procurement for DYCLOPRO

Procurement teams should treat “suppliers” as separate qualification workstreams:

1) API supplier qualification

Key dossier artifacts used in qualification:

• DMF/ASMF (or equivalent confidential dossier access)
• CoA and release specifications for key impurities
• Stability protocol for diclofenac API
• GMP certificate and inspection status

2) Dosage-form manufacturer qualification

Key dossier artifacts:

• BMR/BPR availability for the commercial process
• Validation packages (process validation, cleaning validation, analytical methods)
• Bracketing/matrix strategy for stability
• Container closure system compatibility

3) Secondary suppliers

Common secondary vendors include:

• Packaging: blister/strip, cartons, leaflets
• Analytical: contract testing labs (if not done in-house)
• Serialization/track-and-trace where mandated

Supplier due-diligence checklist for diclofenac products

Use these screening gates to reduce risk of supply disruption and regulatory delays:

• Regulatory readiness: DMF status tied to the target filings in the destination market
• Impurity control: diclofenac impurity profile matching the target specification set
• Consistency: defined particle size and polymorph controls where relevant
• Supply continuity: historical on-time delivery and safety stock capability
• Site compliance: GMP inspection outcomes relevant to oral/topical/sterile manufacturing (as applicable)

Key procurement targets

When buyers request bids, the most actionable supplier fields are:

Procurement Item	Supplier Type	Must-have Data
Diclofenac API	API manufacturer	ASMF/DMF access, CoA, impurity profile, stability summary
Diclofenac sodium vs diclofenac acid	API manufacturer	Correct chemical form matching formulation
Tablets/capsules	CDMO	dissolution method, formulation master spec, validation status
Gel/cream base	CDMO	rheology control specs, container compatibility data
Release testing	CDMO or lab	method validation status, acceptance criteria
Packaging/labeling	packaging vendors	artwork approval workflow, serialization capability

What supplier names should be used?

No supplier list can be produced accurately from the information provided. The brand name DYCLOPRO is not sufficient to uniquely identify:

• the country,
• the dosage form (oral vs topical vs injection),
• and the exact diclofenac chemical form used (diclofenac vs diclofenac sodium),
  which determines the specific API grade and the eligible finished-dose manufacturers.

Key Takeaways

• DYCLOPRO is a diclofenac brand; supplier procurement splits into API, finished-dose manufacturing, and packaging/secondary tiers.
• Supplier selection for diclofenac products is driven by DMF/ASMF readiness, impurity profile matching, dosage-form-specific GMP capability, and stability/validation package completeness.
• A precise supplier name list cannot be generated without unambiguous identification of the market and dosage form for DYCLOPRO.

FAQs

1. Is diclofenac API supply highly diversified? Yes. Diclofenac is a mature generic API with many qualified manufacturing sources, so procurement redundancy is typically high.
2. Does DYCLOPRO require diclofenac sodium or diclofenac free acid? It depends on the specific formulation strength and dosage form used in the target market.
3. What differentiates API suppliers in diclofenac? Impurity profile, particle specs, polymorph control (where applicable), and dossier readiness (DMF/ASMF access).
4. Can one CDMO handle multiple diclofenac dosage forms? Some can, but capabilities are dosage-form specific (oral vs topical vs sterile).
5. What is the fastest path to supplier onboarding for diclofenac? Reuse of existing qualified specs plus verification of matching API grade and validated dosage-form process controls.

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References

[1] U.S. FDA. “Drug Master Files (DMFs).” FDA.
[2] U.S. FDA. “Current Good Manufacturing Practice (CGMP) for Finished Pharmaceuticals.” FDA Guidance.
[3] ICH. “Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances.”