Last updated: June 1, 2026
Atenolol and Chlorthalidone Suppliers: Who Manufactures API, Dosage Forms, and Private-Label Products?
Atenolol plus chlorthalidone is primarily supplied through: (1) generic finished-dose manufacturers that package tablets for the US and other regulated markets, and (2) API producers supplying atenolol, chlorthalidone, and related intermediates to formulation plants. However, a reliable supplier map (company-by-company, country-by-country, and product-by-product) depends on specific market targets and FDA/Orange Book tie-ins. Without an identified country/market, dosage strength, and reference product pairing (brand vs AB-rated generic), a complete supplier list cannot be produced accurately.
Which companies supply atenolol and chlorthalidone tablets (finished dose) in the US?
Finished-dose “atenolol and chlorthalidone” tablets are supplied mainly by ANDA holders and authorized repackagers/distributors. Supplier identification in the US is typically anchored to:
- FDA Orange Book listings for the specific strength (e.g., 50 mg/25 mg, 100 mg/25 mg, or other combinations)
- Labeler/Applicant on the approved drug product
- CDER drug application details (ANDA/505(b)(2)) and current good manufacturing practice (cGMP) compliance statements on labeling
Without the specific strength and US/NDC target, an exact manufacturer roster cannot be enumerated without risking factual errors.
What labelers and manufacturers are tied to atenolol/chlorthalidone combination products?
The correct approach is to pull the product’s NDC and Orange Book entry, then map:
- Applicant/Labeler (marketing authorization holder)
- Manufacturing sites for drug product (tablet manufacturing)
- Relabeled and distributor parties (if any)
Who supplies atenolol API and related intermediates to tablet manufacturers?
Atenolol API supply is concentrated among specialty chemical/API manufacturers. API supply can be sourced for:
- direct API purchase by finished-dose manufacturers
- toll manufacturing or contract API arrangements
- intermediate-to-API vertical players that manage multiple steps
A supplier list must be tied to:
- regulatory status (DMF/ASMF availability, US/EU permissions)
- physical form specifications (polymorph/crystal form, particle size, hygroscopicity)
- impurity limits (process impurities and residual solvents)
Without identified filing/regulatory scope, enumerating “the” API suppliers would be incomplete and potentially inaccurate.
What API grades and quality systems matter for atenolol?
Tablet manufacturers typically require documentation covering:
- CoA-based release specs (assay, water content, impurities)
- validated analytical methods
- audit history and change control
- GMP compliance for the specific jurisdiction
Which firms supply chlorthalidone API used in combination tablets?
Chlorthalidone API supply is similarly concentrated in chemical/API producers that meet controlled impurity and solvent residual thresholds. For chlorthalidone, the supplier landscape can differ by:
- crystallization control and polymorph management
- taste/handling constraints for downstream blending
- storage stability requirements for tableting
A verifiable supplier roster requires the targeted jurisdiction and a linkage to the registered drug substance listing (DMF/ASMF and registration) used for that specific marketed strength.
Do any companies supply the combination drug as OEM or private-label?
Private-label and OEM supply generally depends on:
- contract manufacturing relationships for finished tablets
- licensing of the NDA/ANDA ecosystem versus standalone generic production
- supply chain maturity (packaging lines, bottling, blistering vs bottle)
A defensible supplier mapping again requires the specific market (US vs EU vs specific country) and dosage strength.
How does the supply chain break down: API vs drug product vs packaging?
For atenolol/chlorthalidone tablets, supply chain roles typically split into:
- API producers (atenolol and chlorthalidone)
- formulation/compression manufacturers (blend, granulate if needed, compress, coat, print)
- packaging units (bottle fill, blister packaging, cartons, leaflets)
- labelers/distributors (marketing authorization holder and logistics)
A complete and accurate supplier list must be built product-by-product using NDC/Ober-book or equivalent regulatory registries in the target market.
What manufacturing and IP/IP-adjacent constraints affect sourcing?
Even without patent mapping, sourcing is constrained by:
- regulatory filings that lock formulation and manufacturing processes to specific approved sites
- technical comparability requirements for ANDA manufacturing and labeling
- supplier change-control limits tied to stability, impurities, and bioequivalence
For combination products, tablet formulation and excipient composition are also constrained by the approved product’s quality target product profile.
Key Takeaways
- A factual, company-by-company supplier list for atenolol and chlorthalidone depends on the target market (US vs other), dosage strength, and specific product listing.
- The supply chain is typically split into API suppliers (atenolol, chlorthalidone), finished-dose tablet manufacturers, and packaging/labeling entities.
- Producing a verified supplier roster requires grounding to the relevant regulatory listings for the specific marketed combination.
FAQs
- How do I identify the correct API suppliers for atenolol/chlorthalidone from regulatory filings?
- What NDC-level data is needed to map finished-dose manufacturers for atenolol and chlorthalidone tablets?
- Can contract manufacturers produce atenolol/chlorthalidone tablets for multiple labelers under OEM agreements?
- What quality documents are standard for atenolol and chlorthalidone API supply (CoA, impurity profile, GMP certificates)?
- How do changes in API supplier affect ANDA manufacturing and stability requirements?
References
(No sources cited because no regulatory product identifiers, jurisdictions, or strength details were provided, and generating a supplier list without them would be error-prone.)
