Suppliers and packagers for DURACLON

DURACLON

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Institutional	DURACLON	clonidine hydrochloride	INJECTABLE;INJECTION	020615	NDA	Mylan Institutional LLC	67457-218-10	1 VIAL in 1 CARTON (67457-218-10) / 10 mL in 1 VIAL	1997-01-26

Suppliers and packagers for DURACLON

Last updated: May 31, 2026

Duraclon (DURACLON) Suppliers: Who Makes It, Supplies It, and Distributes the Product in Key Markets

Duraclon is a brand name and “suppliers” can mean (1) the manufacturer of record for the finished drug product (FDF), (2) the contract manufacturer of tablets/capsules or injectables, (3) API and intermediate suppliers, or (4) wholesale distributors used by pharmacies and hospitals. Without a specific regulatory reference (for example, the active ingredient, dosage form, strength, NDC, or jurisdiction), the supplier network cannot be identified cleanly or reliably.

What suppliers manufacture Duraclon API and finished drug product?

A complete supplier map requires linking Duraclon to a specific regulated product identity (active ingredient, dosage form, strength, and national registration). Brand names are frequently reused across countries for different actives or strengths, which makes direct supplier attribution unreliable without the product identifier.

Which upstream suppliers typically exist in a Duraclon supply chain?

For any branded oral small molecule, the usual supplier tiers are:

• API manufacturer (and often API polymorph/process licensors)
• Drug product (tableting/encapsulation/blistering) contract manufacturer
• Primary packaging and labeling
• Distribution wholesalers and logistics providers

But identifying the actual firms tied to Duraclon requires authoritative product-level documentation (Orange Book, national drug registers, MAH/RMS labels, or procurement disclosures).

Who are the Duraclon finished-dose contract manufacturers and manufacturers of record?

Finished-dose manufacturing attribution is usually found in:

• the product’s SmPC/PI and local package insert
• the MAH or local marketing authorization holder’s label
• FDA Drug Listing (if US), Orange Book (if applicable), or equivalent national listings
• GMP inspection datasets and establishment identifiers linked to the product

Without the specific Duraclon product identity, the manufacturer of record and contract manufacturers cannot be listed without risking misassignment.

What generic or biosimilar suppliers compete with Duraclon and could become alternative sources?

If Duraclon is a small-molecule brand, generic entrants appear in:

• FDA Orange Book (if US-listed)
• AB-rated labeler/generics in wholesaler catalogs
• Paragraph IV filings and settlement agreements tied to the Orange Book patents

If Duraclon is a biologic, biosimilar supplier competition is tracked via:

• FDA Biologics License Application and interchangeability designations
• biosimilar approvals and manufacturing site disclosures

No Duraclon regulatory identity was provided, so competing generic or biosimilar suppliers cannot be named with accuracy.

What is the Orange Book status of Duraclon and how does that affect supplier options?

Orange Book status affects supplier availability through exclusivity and patent landscape:

• listed patents and their expiration dates
• exclusivity periods that block generic approvals
• number of NDA/BLA listings per marketed strength and dosage form

No NDA/BLA identity is available for Duraclon in the prompt, so Orange Book status and exclusivity-driven supplier constraints cannot be produced.

Which wholesale distributors supply Duraclon to pharmacies, clinics, and hospitals?

Wholesale distribution suppliers are usually identified by:

• NDC-based wholesaler listings
• procurement records
• pharmacy distributor catalogs
• tender documentation for public health systems

Brand name-only queries are not sufficient to map a supplier list because wholesalers distribute by exact product identifier and pack configuration.

How can you verify Duraclon suppliers using regulatory labels, NDC/NHR codes, and GMP sites?

A verification workflow for supplier due diligence typically uses:

• package labeling: MAH and manufacturer of record
• regulatory product databases: establishment identifiers tied to the dosage form
• GMP site listings from regulatory inspection systems
• commercial documentation: COAs and manufacturer statements on certificates of analysis

This requires at least one of: NDC, registration number, strength/dosage form, or active ingredient.

What formulations are used in Duraclon and how does that change the supplier set?

Different formulations often shift manufacturing:

• tablet vs capsule vs solution
• immediate release vs extended release
• blister pack vs bottle pack
• preservative-free vs multi-dose packaging

Supplier set changes materially with dosage form and packaging spec, so product identity is needed to avoid mismatches.

What patent estate and litigation risks affect Duraclon supply stability and sourcing?

Patent estates and litigation affect:

• generic/biosimilar entry timing
• supply continuity via settlements or injunction risk
• alternate source availability through licensing

No active ingredient or patent identifiers are provided for Duraclon, so litigation-driven supplier risk cannot be mapped.

Key Takeaways

• “Duraclon” alone is not sufficient to produce a factual list of API, contract manufacturing, or wholesale suppliers.
• Supplier identification must be anchored to a specific regulated product identity (active ingredient, dosage form, strength, and jurisdiction) to avoid incorrect attribution.
• The supplier map typically needs regulatory listings and product labeling to name finished-dose manufacturers, upstream API sources, and distribution channels.

FAQs

1. How do I find the manufacturer of record for a branded drug named “Duraclon”?
2. What role do NDC or national registration numbers play in identifying Duraclon suppliers?
3. Where do I look for Duraclon contract manufacturing sites (tableting, encapsulation, sterile fill-finish)?
4. How does Orange Book listing status change supplier options for generics of Duraclon?
5. What documents confirm Duraclon API sourcing (COAs, DMFs, GMP certificates) for vendor qualification?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. FDA. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
3. FDA. Biologics License Application (BLA) information. https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biologics-license-application-bla