Last updated: May 28, 2026
ATACAND HCT is a fixed-dose combination of candesartan cilexetil and hydrochlorothiazide (HCTZ). It is marketed in the US under an AstraZeneca label; the supplier base is driven by AstraZeneca’s contracted contract manufacturing and packaging networks for tablets, plus upstream API sourcing for candesartan cilexetil and HCTZ.
Key suppliers and manufacturers depend on market, site, and labeler of record. Without identifying the specific market geography and the exact US NDA/BLA labeler or Orange Book drug product entry, a complete, audit-grade supplier list cannot be produced.
What companies supply ATACAND HCT (candesartan cilexetil + hydrochlorothiazide) tablets?
Answer: The branded product is marketed under AstraZeneca’s label. The specific manufacturing and packaging suppliers can include AstraZeneca’s manufacturing sites and contract manufacturing organizations (CMOs) used by AstraZeneca for oral tablet production, along with API suppliers for candesartan cilexetil and HCTZ.
Who is the labeler of record for ATACAND HCT?
Answer: AstraZeneca is the drug’s marketer/labeler in the US.
Who manufactures the tablets?
Answer: Tablet production is typically performed at AstraZeneca manufacturing sites and/or AstraZeneca-authorized CMOs under commercial supply arrangements. Site-level identity requires matching the finished dosage form strength and NDC to the FDA drug product listing.
Who supplies the APIs?
Answer: Upstream supply typically includes:
- candesartan cilexetil API (or immediate precursor supply) from specialized API manufacturers used by AstraZeneca
- hydrochlorothiazide API from generic API suppliers used by brand programs
What information is needed to name exact suppliers?
Supplier names in a litigation-grade sense require the NDC-level drug product listing, then mapping to:
- the FDA “Drug Label Information” and “Drug Listing”
- Orange Book “drug product” entries (including dosage form, strength, and applicant/holder)
- labeling “Manufactured for” and “Packaged by” statements on commercial cartons and inserts
- inspection and supply-chain disclosures (if available for the specific site)
What is the Orange Book status of ATACAND HCT?
Answer: ATACAND HCT is listed in FDA’s Orange Book as a branded, prescription drug product (combination of ARB candesartan and thiazide diuretic HCTZ). The Orange Book also contains corresponding patent listings and exclusivity status by active ingredient and formulation.
Does ATACAND HCT have generic or AB-rated competitors?
Answer: Generic entry is commonly possible after patents and exclusivities expire for the relevant strengths and formulation. Whether an abbreviated new drug application is rated “AB” depends on current product availability and FDA approvals for each strength.
Which manufacturers make candesartan cilexetil API and hydrochlorothiazide API for brands?
Answer: Both APIs have established global commercial suppliers, but identifying which ones supply ATACAND HCT requires tying AstraZeneca’s current commercial supply chain to:
- the specific approved drug product entry
- documented API sourcing in regulatory submissions and/or site certificates
- carton labeling and US NDC packaging statements
Candesartan cilexetil API: supplier landscape
API supply is concentrated among specialty chemical and API manufacturers with capability around advanced heterocycle synthesis and cilexetil ester handling.
Hydrochlorothiazide API: supplier landscape
HCTZ API is widely supplied by multiple generic API manufacturers globally.
What dosage forms and strengths are supplied for ATACAND HCT?
Answer: ATACAND HCT is supplied as oral tablets containing a combination of candesartan cilexetil and hydrochlorothiazide. Supplier site selection can vary by strength.
How do NDCs map to manufacturing sites?
Answer: Different strengths often have different NDCs. Each NDC can map to different manufacturing and packaging sites, and label statements can differ by geography and labeling configuration.
How does supplier identity affect FDA inspections and supply continuity?
Answer: Supplier sites drive:
- FDA inspection assignments
- quality system availability
- change-control timelines and variation approvals
What manufacturing controls are typically relevant for tablet supply?
- blending and granulation process controls
- tablet compression and coating controls
- bioburden, sterility (not applicable to oral tablets), and microbial limits
- stability and shelf-life assignment
What generic entry risks exist for ATACAND HCT supplier chains?
Answer: Generic entry pressures can shift procurement from brand-exclusive sources to shared supply chains across multiple products. The highest risk areas are:
- API sourcing availability
- intermediate supply continuity for candesartan cilexetil
- packaging line capacity for specific NDC/strength configurations
How does ATACAND HCT compare with other candesartan + HCTZ combinations on supply?
Answer: Other branded combinations (or authorized generics) may use the same ARB API but different packaging and formulation sites. Without NDC-level mapping, cross-brand supplier comparisons cannot be done reliably.
Key Takeaways
- ATACAND HCT is marketed under AstraZeneca and is produced as a fixed-dose oral tablet combination of candesartan cilexetil plus hydrochlorothiazide.
- Supplier identity at the level of named companies for tablets and APIs requires NDC-level matching to FDA drug product listings and/or carton labeling statements.
- A complete supplier list cannot be generated from the ATACAND HCT name alone without tying to a specific drug product entry (strength and NDC) and the corresponding labeler-manufacturer packaging statements.
FAQs
- Who is the marketing authorization holder (labeler) for ATACAND HCT in the US?
- Do tablet manufacturing sites differ by ATACAND HCT strength?
- Which APIs are used in ATACAND HCT and who typically supplies them?
- How can I identify the “manufactured for” and “packaged by” suppliers for ATACAND HCT?
- Where can supplier identity be verified for ATACAND HCT: Orange Book, label, or inspections?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (accessed 2026-05-28).
- U.S. Food and Drug Administration. Drugs@FDA: FDA Application and Approval History. (accessed 2026-05-28).
