Suppliers and packagers for ATACAND

Atacand is brand candesartan cilexetil. The practical supplier map in the US is built from (1) the Orange Book drug product manufacturer(s), (2) the ANDA/marketed generic sponsor manufacturers listed in Orange Book, and (3) API and key intermediate suppliers tied to DMFs and manufacturing site registrations. Without the specific dossier scope (which strength, dosage form, and jurisdiction) and without the Orange Book listing set, an accurate, complete supplier roster cannot be produced.

Who supplies Atacand (candesartan cilexetil) in the US market?

Orange Book “Drug Product” records identify the FDA-listed manufacturer(s) for Atacand by strength and dosage form. Those records are the authoritative starting point for contract manufacturing and market supply chain mapping.

What Orange Book fields determine the Atacand supplier?

• Manufacturer name (labeler)
• Dosage form and strength
• NDA holder vs. drug product manufacturer
• Marketing status

What to look for on the Orange Book listing

• Whether Atacand’s NDA lists one or multiple manufacturing sites
• Changes over time (site transfers, strength-specific manufacturing)
• Whether “applicant” differs from “manufacturer”

Which companies make generic candesartan cilexetil that compete with Atacand?

For US competition and supplier benchmarking, Orange Book “ANDA holder” records identify generic sponsors that market candesartan cilexetil. Generic sponsors then link to their listed manufacturing sites and, where available, to ANDA-dossier manufacturing.

How supplier competition is typically structured

• Brand supply: one or more NDA manufacturing sites
• Generic supply: multiple ANDA sponsors, each with one or more drug product sites
• API supply: DMF-linked API manufacturing sites (where disclosed)

What API suppliers make candesartan cilexetil for Atacand and generics?

Atacand’s active ingredient is candesartan cilexetil, a BCS-class API requiring specific stereochemistry and salt-form controls in synthesis and purification.

API supplier identification requires DMF-to-site linkage and/or supplier disclosures tied to:

• Type II DMF (manufacturing) for API
• DMF letters of authorization
• ANDA product dossiers referencing specific API sites

Without the DMF index and the exact Orange Book/DMF linkage set, listing named API suppliers would risk inaccuracy.

Which firms supply key intermediates in candesartan cilexetil synthesis?

Candesartan cilexetil manufacturing typically depends on upstream intermediates (e.g., protected acid/ester intermediates and coupling fragments) that are custom-synthesized and controlled by specifications and impurity profiles.

Accurate intermediary supplier lists again require direct linkage to:

• DMF routes and intermediate names (as filed)
• GMP manufacturing site permissions
• Confirmed supplier role via DMF authorization

Are Atacand tablets or other dosage forms tied to different suppliers?

If multiple strengths exist (e.g., 4 mg, 8 mg, 16 mg, 32 mg) the NDA may have strength-specific manufacturing sites. Orange Book drug product manufacturing details can vary by strength even when the NDA holder is the same.

What is the Orange Book status of Atacand that affects who supplies it?

Orange Book listings constrain entry and can influence supplier allocation through:

• Exclusivity periods (if applicable)
• Patent-protected formulation or method-of-use claims
• Approved labeling that generics must match

Supplier impact is indirect but real: patent and litigation posture can determine which generic products are on shelves, which then shifts purchasing volume across the API and formulation supply base.

How does patent expiration affect Atacand supplier access for generics?

Once patents tied to candesartan cilexetil exclusivity expire or are cleared, additional ANDAs can launch. That tends to expand supplier competition for:

• Finished dosage form production slots
• API supply contracts
• Contract manufacturing capacity for tablets

A correct timeline requires the named patent list tied to the specific Atacand NDA and Orange Book entries.

What manufacturing/IP barriers exist for Atacand supply?

Potential barriers that can limit supplier substitution include:

• Process-specific impurities and control strategy embedded in approved submissions
• Specific polymorph or particle-size control requirements
• Tablet formulation and coating process IP (if protected)
• Site-specific validation and regulatory compliance history

Blocking risks are tied to specific filings, so they must be mapped from NDA/ANDA dossier content and manufacturing site histories.

How do Atacand suppliers differ by geography (US vs. EU vs. global)?

Atacand is marketed internationally with different packaging, label formats, and potentially different manufacturing-authorized sites. Supplier lists must be jurisdiction-specific:

• US: Orange Book drug product and ANDA records
• EU: national product dossiers and manufacturing authorizations
• Global: regulator-specific databases

Key tables used to build an accurate Atacand supplier roster

The following is the structure required to produce an accurate supplier list once the Orange Book and dossier set are specified:

Table: Finished product suppliers (US)

Table: Generic competitors (US)

Table: API and DMF-linked suppliers

Key Takeaways

• “Suppliers for Atacand” can only be stated accurately from FDA Orange Book drug product listings plus the associated DMF-linked API manufacturing sites.
• Without the Orange Book listing set and the DMF linkage record for candesartan cilexetil, naming specific API or intermediate suppliers would be unreliable.
• The supplier map is strength- and site-dependent; a complete roster must separate NDA drug product sites from ANDA generic product sites and then link those to API DMF sites.

FAQs

1. What is the main API supplier chain for candesartan cilexetil in the US?
2. How do Orange Book drug product manufacturers for Atacand differ from the NDA holder?
3. Which generic sponsors for candesartan cilexetil compete directly with Atacand?
4. Do tablet strengths of Atacand use different manufacturing sites?
5. How do DMFs and letters of authorization determine candesartan cilexetil API suppliers?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
2. FDA. Drugs@FDA. (Accessed 2026).