Last updated: May 28, 2026
MICARDIS HCT is a fixed-dose combination of telmisartan (angiotensin II receptor blocker) and hydrochlorothiazide (thiazide diuretic). Supplier identification for the product level depends on the specific NDC strengths and whether the reference is to API, finished dosage manufacturing, or label/packaging. With the information provided, a complete, accurate, NDC-specific supplier map cannot be produced.
What companies supply MICARDIS HCT manufacturing and packaging services?
No complete supplier roster can be compiled from the prompt alone. Supplier attribution at this granularity normally requires NDC-specific source data tied to FDA filings (e.g., CMC manufacturing sites listed in labeling and/or drug master files), Orange Book listings, and product-specific manufacturing/packaging statements.
How to identify MICARDIS HCT finished-dose manufacturers by strength and NDC
Finished-dose suppliers are commonly determined by:
- NDC labeler/manufacturer listed in FDA product databases and labeling
- “Manufactured for” and “Distributed by” lines in prescribing information
- Site-specific manufacturing and packaging descriptions in FDA review documents
Without NDC-level inputs, finished-dose supplier identification is incomplete.
How packaging suppliers (labeling, bottles, blister) are determined
Packaging suppliers typically show up in:
- Label text and package insert manufacturing statements
- Site listings in FDA CMC summaries and approval packages
NDC-specific packaging attributions are not derivable from the prompt.
Who supplies telmisartan API and hydrochlorothiazide API used in MICARDIS HCT?
MICARDIS HCT uses two active ingredients with separate upstream supply chains:
- Telmisartan (API)
- Hydrochlorothiazide (API)
A credible API supplier list requires cross-referencing:
- FDA DMF holders and cross-references tied to the relevant products
- Commercial vendor disclosures
- Orange Book “Applicant” and supporting CMC site data
The prompt provides the product name only, which is insufficient to produce a definitive, complete API supplier list.
Which API supply categories matter for risk
Supply chain risk analysis usually splits sourcing into:
- API synthesis origin (DMF-backed supply vs alternative routes)
- Compliance status (facility inspection outcomes)
- Lot-specific traceability and intermediates
Those facts cannot be populated without filings-level inputs.
What is the Orange Book status of MICARDIS HCT that affects supplier sourcing?
Orange Book status impacts who can manufacture generics (and who can compete on supply), but it does not, by itself, enumerate the finished-dose or API suppliers for the brand product.
How Orange Book data is used to infer supplier networks
Key Orange Book fields used in sourcing work:
- “Applicant” and NDA holder
- Dosage forms and strengths
- Patent-exclusivity context that shapes generic entry and parallel supply
A supplier roster still requires separate manufacturing-site data.
Who are the MICARDIS HCT labeler and NDA holder, and what does that imply for suppliers?
NDA holder and labeler usually align with:
- Brand commercial organization
- Contract manufacturing and packaging relationships for finished tablets
But without the specific NDC and the product record, the NDA holder and labeler cannot be asserted in a way that supports business decisions.
Which generic and authorized manufacturers could supply MICARDIS HCT equivalents?
Generic MICARDIS HCT equivalents depend on:
- FDA approvals for AB-rated generics and authorized generics
- Patent and exclusivity timelines
- ANDA manufacturing readiness
A supplier list for generics cannot be reliably generated from product name alone.
What manufacturing/IP barriers affect who can become a MICARDIS HCT supplier?
Even if supply capacity exists, barriers often include:
- Market authorization requirements (ANDA/505(b)(2) CMC compliance)
- Patent constraints and regulatory exclusivity constraints
- Formulation and process validation expectations for tablets
These barriers depend on the specific strengths and the regulatory status at issue.
Supplier map by strength: 40/12.5, 80/12.5, 80/25
No strength-specific supplier mapping can be produced from the prompt. MICARDIS HCT is marketed in multiple combinations, and suppliers can differ by:
- Manufacturing site assignment per strength
- Packaging line allocation
- Label configurations and distribution channels
Key Takeaways
- MICARDIS HCT is a telmisartan plus hydrochlorothiazide fixed-dose tablet combination.
- Supplier identification for MICARDIS HCT requires NDC-specific FDA product record and site-specific manufacturing/packaging statements.
- The provided input does not include the NDCs or any FDA/label data needed to generate a complete, accurate supplier list for API and finished-dose manufacturing.
FAQs
- Which NDCs correspond to MICARDIS HCT strengths and label configurations?
- How can API DMF holders be matched to the MICARDIS HCT product?
- Do finished-dose manufacturers change across MICARDIS HCT strengths?
- What is the difference between finished-dose manufacturing and primary packaging suppliers for tablet products?
- How do patent and exclusivity status influence who can supply MICARDIS HCT generics?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-05-28).
