Last updated: June 2, 2026
ZIAC (bisoprolol fumarate + hydrochlorothiazide): who supplies the active ingredients and finished-dose product?
ZIAC is a fixed-dose combination of bisoprolol fumarate (beta-1 selective blocker) and hydrochlorothiazide (thiazide diuretic). The supply chain splits into: (1) API manufacturing for each component, and (2) finished-dose manufacturing (FDF) under NDA/ANDA labeling.
No sufficient, source-backed dataset is provided here to name specific suppliers (API sites, contract manufacturers, or labeled finished-dose manufacturers) for ZIAC in the US or EU, including which plants hold DMFs, which companies appear on the FDA Orange Book/Drug Label, or which distributors are tied to specific NDCs.
Which companies supply ZIAC APIs (bisoprolol fumarate and hydrochlorothiazide)?
Answer (data unavailable in provided material): Not determinable without supplier-verified listings (for example, FDA DMF/Letter of Authorization ties to Orange Book/NDA references, or publicly indexed DMF holders tied to each API grade).
What supplier types exist for ZIAC APIs?
- API DMF holders for bisoprolol fumarate and hydrochlorothiazide
- API manufacturers (often multiple sites per DMF)
- API traders/distributors that do not hold DMFs
- Generic API supply aligned to ANDA development programs
What to look for in supplier verification
- DMF holder name and cross-reference to the application that lists ZIAC
- Site-level manufacturing controls and quality agreements (audit trail)
- Grade and specification (pharma grade, particle size, polymorph behavior, residual solvents for thiazides)
Which manufacturers supply the ZIAC finished-dose tablets in the US (by NDC)?
Answer (data unavailable in provided material): Not determinable without NDC-to-labeler mapping and manufacturer-of-record fields from FDA label data or packaging inserts tied to each marketed strength.
What drives finished-dose “supplier” identification
- Labeler/Applicant of record on FDA labeling
- Manufacturing site shown on package/label (often “Manufactured for…”)
- ANDA vs NDA applicant and their contract manufacturer(s)
What is the Orange Book status of ZIAC and how does it identify supplier linkages?
Answer (data unavailable in provided material): Not determinable without Orange Book entry identifiers for ZIAC (application numbers, exclusivity, listed patents) and the application-to-manufacturer records.
How supplier identification works via Orange Book
- Orange Book lists application holder and patents.
- Label and submission data tie the application to manufacturing responsibilities.
- DMF references and cross-references can identify API sourcing.
Do generic ZIAC tablets change the supplier list versus branded ZIAC?
Answer (data unavailable in provided material): Not determinable.
Why generics can shift suppliers
- Different ANDA applicants often use different API DMFs
- Different film-coating/compression contract sites are used for tablets
- Different NDCs reflect different manufacturing and labelers
Which dosage strengths and forms matter for ZIAC supply contracts?
Answer (data unavailable in provided material): Not determinable.
Common market splits that affect sourcing
- Strength-specific APIs and processing controls
- Tablet imprinting/coating differences
- Pack size and distribution channel (pharmacy vs mail-order vs hospital)
How to assess the reliability of ZIAC suppliers (risk view)
Answer (data unavailable in provided material): Not determinable.
Supplier risk factors typically evaluated
- FDA inspection outcomes for tablet press or API sites
- Recalls or quality alerts tied to specific lot control
- Capacity concentration for both bisoprolol fumarate and hydrochlorothiazide
- Regulatory history for bioequivalence batches (for generics)
Key Takeaways
- ZIAC is bisoprolol fumarate + hydrochlorothiazide, but specific supplier names for APIs or finished-dose tablets cannot be provided from the information supplied.
- Supplier identification requires Orange Book/NDC label mapping and DMF holder linkages, none of which are included in the current prompt.
FAQs
- How can I identify the API DMF holder for bisoprolol fumarate used in ZIAC?
- Which fields in FDA labeling indicate the ZIAC manufacturer of record for each NDC?
- Do contract manufacturing sites change between ZIAC generics by strength?
- What regulatory documents connect ZIAC ANDAs to specific API suppliers?
- How do FDA recalls map to ZIAC supplier lots and plants?
References
- (No sources provided in the prompt.)
