Suppliers and packagers for EDECRIN

EDECRIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	EDECRIN	ethacrynic acid	TABLET;ORAL	016092	NDA	Bausch Health US, LLC	25010-215-15	100 TABLET in 1 BOTTLE (25010-215-15)	1967-01-10
Bausch	EDECRIN	ethacrynic acid	TABLET;ORAL	016092	NDA AUTHORIZED GENERIC	Oceanside Pharmaceuticals	68682-011-10	100 TABLET in 1 BOTTLE (68682-011-10)	1967-01-10

Edecrin (Edesuril/Sulfinpyrazone) Suppliers: Who Manufactures It, Who Controls Supply, and Where Procurement Risk Sits

Last updated: June 3, 2026

Edecrin is the brand name for sulfinpyrazone, an oral anti-gout (uricosuric) drug. It has a limited supplier footprint versus large-scale branded therapies, and market availability can be fragmented across countries and contract manufacturers. This supplier picture is typically governed by (1) the original marketing authorization holder and (2) the current commercial manufacturer(s) listed on country-specific labels and regulatory filings, with (3) API and intermediate sourcing captured in DMF/CEP records and manufacturer declarations.

What suppliers produce Edecrin (sulfinpyrazone) in the supply chain? Primary supply for Edecrin typically breaks into three tiers:

• Marketing authorization holder / brand owner: Holds the branded product approval and directs commercial manufacturing.
• Finished dosage form manufacturer (FDF): Produces tablets, packages, and releases product to the market.
• API and intermediate manufacturers: Supply sulfinpyrazone API and key intermediates, often managed through DMFs and change-control for manufacturing sites.

For Edecrin specifically, the supplier set is constrained by the drug’s age, smaller demand base, and periodic manufacturing site changes. In practice, procurement and continuity depend on the current FDF release sites named on the marketed package labeling and the API sources referenced in regulatory submissions for each jurisdiction.

Which companies manufacture Edecrin tablets and control finished product release? Featured snippet answer: The finished product supplier is the company named on the marketed package labeling and the company listed as the product manufacturer on regulatory databases for each country. For sulfinpyrazone brand supply, these manufacturers can differ by geography and by authorization holder.

To map “who supplies Edecrin” for procurement or licensing, the actionable route is the regulatory label chain:

1. Country marketing authorization: identifies the marketing authorization holder and manufacturing sites.
2. SmPC/leaflet and labeling: lists manufacturers responsible for manufacturing and release.
3. Variations history: indicates manufacturing site substitutions and API change approvals.

Because “Edecrin” naming and supplier identity vary by country, a single global supplier list is not reliable without tying the market to a specific regulatory jurisdiction.

What is the API supply chain for sulfinpyrazone (Edecrin)? Featured snippet answer: Sulfinpyrazone API is made by specialized chemical manufacturers under DMF/CEP arrangements, with intermediates synthesized and purified to drug substance specifications. Contract API suppliers for older small-molecule brands often rotate less frequently than large biologics, but changes do occur and are reflected in DMF updates and regulatory notifications.

Procurement risk points for API:

• DMF status and cross-reference access (who owns the DMF and whether it is open to a new customer)
• Site qualification and validation readiness
• Batch consistency for impurity profiles and polymorph control (if applicable to the API’s solid form requirements)

Which API manufacturers typically appear for sulfinpyrazone under DMF/CEP filings? Featured snippet answer: The API manufacturer(s) are those referenced in DMF filings or CEP certificates for sulfinpyrazone, and they are usually listed in regulatory documents linked to the marketed product.

A supplier list can be compiled only by extracting the named API manufacturers from jurisdiction-specific submissions. In the absence of those label/regulatory extracts in this request, providing specific company names would risk producing an inaccurate or incomplete supplier map.

How does Edecrin availability differ across countries, and how does that affect suppliers? Featured snippet answer: Edecrin supply depends on national marketing authorization status and local manufacturing and release requirements. Even when the same brand is referenced, the marketed product may be produced and packaged at different manufacturing sites across markets.

This affects suppliers because:

• A distributor may repackage product but not change the manufacturing site.
• National authorization holders can shift finished-product release sites during regulatory variations.
• API suppliers can change while the finished product site remains constant (or vice versa).

What commercial entities distribute Edecrin (sulfinpyrazone) versus manufacture it? Featured snippet answer: Distributors are usually not the manufacturer; they are the commercial channel. Procurement must distinguish:

• Importer / distributor (handles logistics and market access)
• Finished product manufacturer (produces and releases drug product)
• API manufacturer (produces drug substance)

Contract manufacturing and packaging can be split across entities, so a distributor’s name does not identify the manufacturing supplier.

What procurement questions determine supplier quality and continuity for Edecrin? Featured snippet answer: For small-molecule brand continuity, the highest-value procurement checks are manufacturing-site GMP status, release testing scope, and regulatory change history.

Key diligence items:

• Current GMP certificate for the finished product site(s)
• Evidence of batch release testing controls for impurities and assay
• Regulatory variation records for site changes (manufacturing and API)
• Supply agreements that address allocation during shortages

How do generic competition and market decline affect Edecrin suppliers? Edecrin is an older sulfinpyrazone brand. When brand demand declines or product approvals consolidate, supplier networks compress. That leads to:

• Fewer qualified finished product sites
• Lower availability buffer stock
• Greater sensitivity to API supply interruptions or regulatory variation approvals

What settlement, exclusivity, or regulatory posture affects supplier lists for Edecrin? Supplier availability for older small molecules is typically driven more by:

• whether the brand remains authorized and commercially marketed in a given country
• whether manufacturers continue to produce under approved MAAs than by exclusivity or blockbuster-style patent estates.

A practical supplier audit is therefore regulatory and label-based rather than patent-family-based.

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Key Takeaways

• “Suppliers for Edecrin” must be defined by jurisdiction and by whether the buyer needs the finished-product manufacturer, the API supplier, or the commercial distributor.
• The most reliable supplier identification comes from marketed product labeling and country-specific regulatory submissions that name the manufacturing and release sites.
• For sulfinpyrazone, the supplier network is typically smaller than for high-volume brands, so availability and continuity depend heavily on a limited number of qualified sites and their API continuity.

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FAQs

1. How do I identify the finished-product manufacturer for Edecrin in my country?
   Use the product labeling/manufacturing section in the country SmPC/package insert that lists the manufacturing and release sites.

2. Who supplies the sulfinpyrazone API used in Edecrin?
   The API supplier is named in DMF/CEP-linked regulatory documentation for sulfinpyrazone in the specific marketed product jurisdiction.

3. Are Edecrin distributors the same as the manufacturers?
   Usually no. Distributors handle market access and logistics; manufacturing and release are handled by GMP-qualified sites named on labeling.

4. Why can Edecrin suppliers change over time even if the brand name stays the same?
   Manufacturing site changes and API supplier changes occur through regulatory variations without changing the brand name.

5. What is the highest-impact procurement risk for an older brand like Edecrin?
   Supply continuity risk from a small number of finished-product and API-qualified sites and their ability to maintain GMP release and impurity controls.

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References

1. FDA. Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations. (Accessed 2026-06-03).
2. EMA. European public assessment reports and product information for medicinal products. (Accessed 2026-06-03).
3. WHO. General guidance on assessment of medicinal products (for GMP and regulatory documentation context). (Accessed 2026-06-03).