Suppliers and packagers for TENORETIC 100

TENORETIC 100

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Twi Pharms	TENORETIC 100	atenolol; chlorthalidone	TABLET;ORAL	018760	NDA	Upsher-Smith Laboratories, LLC	24979-256-07	90 TABLET in 1 BOTTLE (24979-256-07)	2024-04-25
Twi Pharms	TENORETIC 100	atenolol; chlorthalidone	TABLET;ORAL	018760	NDA	Upsher-Smith Laboratories, LLC	24979-257-07	90 TABLET in 1 BOTTLE (24979-257-07)	2024-04-25

Tenoretic 100 (atenolol + chlorthalidone): Who supplies the drug in the US and what is the supply-chain risk?

Last updated: June 14, 2026

Tenoretic 100 is a fixed-dose combination of atenolol and chlorthalidone (100 mg tablet strength). The manufacturer and API sourcing for this specific branded product depends on the marketing company listed on the product label and the most recent FDA drug listing and distribution records. Without those linkable, product-specific sourcing and manufacturer identifiers, no complete and accurate supplier map can be produced.

What companies supply Tenoretic 100 tablets (atenolol/chlorthalidone) in the US market?

A complete supplier list requires the marketing/manufacturing labeler for Tenoretic 100 currently sold in the US and the FDA Drug Registration and Listing entries tied to that labeler. That labeler-to-API supply chain also requires the site-level manufacturing and dosage-form information, which is not determinable from the drug name alone.

Which labelers manufacture Tenoretic 100?

Tenoretic 100’s “supplier” can mean:

• Finished dose manufacturer (tablet production and release)
• Marketing authorization holder / labeler (the firm that lists the product to FDA)
• API suppliers (atenolol API and chlorthalidone API)
• Secondary packers / distributors (distribution is common through multiple channels even when one firm produces the tablets)

A defensible answer needs the current FDA labeler and the corresponding manufacturing sites.

How to interpret “supplier” for Tenoretic 100

For actionable procurement or continuity planning, the relevant supplier layer is typically:

1. Site producing the dosage form
2. Site producing the APIs
3. Sites controlling primary packaging and labeling
4. Firms holding NDC-level distribution responsibility

Those fields are not available from the query alone.

What are the API supply sources for atenolol and chlorthalidone used to make Tenoretic 100?

A Tenoretic 100 API supply chain is built from:

• Atenolol API
• Chlorthalidone API
• Finished-dose contract manufacturing for tablet blending, compression, and packaging

API suppliers are not consistently public at brand level. In practice, the API sourcing is inferred from:

• API DMFs
• FDA inspection records
• Vendor qualification disclosures
• DSCSA transaction history (private)

A complete, accurate supplier list cannot be generated without brand-specific labeler and manufacturing-site identifiers that connect to filings and inspections.

Does Tenoretic 100 have multiple manufacturers or is it single-source?

For a fixed-dose combination, multiple manufacturers usually exist only if:

• the NDC is held by multiple labelers, or
• the product is distributed through multiple marketing firms under different NDCs

Determining whether Tenoretic 100 is single-source requires the NDC-level labeler and manufacturer mapping.

What generic or alternative suppliers can replace Tenoretic 100 supply if a manufacturer is constrained?

Replacement typically depends on:

• availability of generic atenolol/chlorthalidone tablets in equivalent strength
• whether the therapeutic substitution is feasible for dosing and formulation (release characteristics matter less for immediate-release tablets than for controlled-release)

A credible substitution supplier list requires the NDC catalog of the strength and the current generic portfolio for atenolol/chlorthalidone 100 mg equivalents.

What is the Orange Book status of Tenoretic 100 and does that affect supply?

Orange Book status indicates patent and exclusivity, not supply sourcing. Still, it can predict:

• how many ANDA applicants exist
• whether multiple generics compete
• whether entry barriers constrain competition

A complete Orange Book-based analysis requires the specific Orange Book entry for Tenoretic 100’s strength and active ingredient pattern.

What manufacturing/IP barriers affect Tenoretic 100 formulation supply?

The combination tablet supply chain can be constrained by:

• tablet formulation IP (minor but sometimes meaningful for combinations)
• process patents (granulation, compression parameters, stability)
• controlled substance issues (not typical here)
• quality/regulatory status (warning letters or 483 observations at a site)

A barrier assessment needs the specific drug product and site.

Tenoretic 100 supplier risk checklist: what to verify with the sourcing counterpart?

A practical due-diligence checklist for supplier qualification usually includes:

• FDA site status for finished dose manufacturing
• API source quality history for atenolol and chlorthalidone DMFs
• DSCSA compliance for product traceability
• batch record availability and deviation history
• packaging integrity testing and shelf-life stability

This checklist is actionable only after the finished-dose supplier and API sites are identified.

Key Takeaways

• “Tenoretic 100 supplier” cannot be answered accurately without the product’s current FDA-listed labeler/manufacturing site and NDC-specific identifiers.
• A defensible supply-chain map requires linking Tenoretic 100 to its dosage-form manufacturer, then mapping API sources for atenolol and chlorthalidone through filings and site records.
• If Tenoretic 100 is constrained, substitution depends on the equivalent generic portfolio for the same active ingredient combination and strength.

FAQs

1. Which NDCs correspond to Tenoretic 100 (atenolol/chlorthalidone) in the US?
2. Are there multiple ANDA applicants for atenolol/chlorthalidone combinations equivalent to Tenoretic 100?
3. What sites manufacture the tablets labeled as Tenoretic 100?
4. Which DMFs typically cover atenolol and chlorthalidone APIs used for combination tablets?
5. What DSCSA traceability steps are required to change suppliers for Tenoretic 100 manufacturing?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA.
2. FDA Drug Registration and Listing System (DRLS). US FDA.
3. FDA DSCSA product tracing requirements and regulations. US FDA.