Last updated: June 1, 2026
TIAZAC (diltiazem hydrochloride) Suppliers: Who Manufactures API, FDF, and Key Components for US Market Supply?
TIAZAC is the brand of diltiazem hydrochloride (immediate-release capsules) sold in the US as a generic-equivalent multi-source drug; supply is handled through a standard API-and-FDF chain involving multiple API makers (diltiazem HCl) and multiple finished-dosage manufacturers licensed to distribute under NDA/label agreements.
Hard supplier identification by name requires Orange Book labeling and FDA drug listing detail for TIAZAC’s specific NDC(s) and strength (TIAZAC is commonly marketed as 2 strengths depending on label history). That NDC-specific sourcing cannot be produced from the input provided.
What companies supply the drug substance diltiazem hydrochloride (API) used for TIAZAC?
TIAZAC uses diltiazem hydrochloride as the active pharmaceutical ingredient. The API supply base for diltiazem HCl is typically multi-origin, with global API manufacturers supplying contracts that feed finished-dose plants.
API supplier lists are tied to:
- the specific diltiazem HCl grade (capsule-facing API particle controls, polymorph form specifications)
- the cGMP site that supplies the particular finished-dose contract manufacturing organization (CMO)
- the period covered by a given reference label and NDC changes (site transfers occur)
Without the TIAZAC exact NDC(s) and current labeler/manufacturer-of-record, a compliant, accurate company-by-company supplier roster cannot be stated.
Which API sites are typically used for diltiazem HCl?
Commonly observed for diltiazem HCl across the market are:
- Chinese and Indian API manufacturers
- European API houses
- US-based traders and repackage/distribution channels
Named supplier accuracy for TIAZAC cannot be established from the provided prompt.
Who manufactures TIAZAC finished dosage forms (FDF) in the US?
TIAZAC is a capsule product. Finished dosage manufacturing is typically performed by:
- the NDA holder or licensee for the product label, or
- an outsourced CMO/packager listed as manufacturer-of-record by FDA listing
A named supplier list requires mapping TIAZAC labeler/holder and NDC-to-manufacturer on the FDA database for the specific strengths.
Are capsules manufactured in US or abroad?
For many immediate-release cardiovascular capsules, manufacturing footprint is global and labeler-dependent. Determining the US vs foreign manufacturing for TIAZAC requires NDC-specific FDA listing.
What NDC-level sourcing determines “suppliers” for TIAZAC?
For practical procurement and litigation due diligence, “suppliers for TIAZAC” typically means one or more of the following, each tied to NDC:
- Labeler (FDA listing labeler name)
- Manufacturer of record (site)
- Packager (if different)
- Repackager or distributor (if relevant)
- Application holder/label owner
The prompt does not include the NDC(s) or strength(s), so these entities cannot be enumerated.
How do API and FDF supplier chains affect TIAZAC shortages and continuity of supply?
TIAZAC continuity depends on:
- API lead times for diltiazem HCl
- capsule and packaging components (gelatin/HPMC capsule supply, ink and printing, bottle closures)
- site capacity at the FDF manufacturer
In multi-sourced markets, supply disruption in one API site usually shifts to another via qualification, but the exact substitution path is product-and-time specific.
What component suppliers matter for TIAZAC manufacturing (capsules and packaging)?
For immediate-release capsule products, procurement-critical components include:
- capsule shells (gelatin or HPMC)
- excipients (granulation aids, binders, disintegrants)
- packaging (bottles, closures, desiccant where applicable)
- printing/label substrate and lot coding systems
A named list of component suppliers is not determinable from the prompt because those suppliers are not typically publicly tied to the brand label without NDC-specific FDA listing plus supply chain disclosures.
How does the generic ecosystem for diltiazem HCl affect TIAZAC supplier availability?
TIAZAC sits in the broader diltiazem HCl capsule landscape, which is commonly multi-generic. That structure increases:
- competitive API procurement options
- alternative FDF sourcing opportunities
- risk of labeler transitions due to CMO swaps
Still, supplier identity for the specific brand cannot be stated without NDC-specific label data.
Key Takeaways
- “Suppliers for TIAZAC” cannot be answered with named companies from the provided information because supplier identification is NDC- and strength-specific.
- Supplier mapping requires FDA listing fields that connect TIAZAC’s specific NDC(s) to manufacturer-of-record and labeler.
- The diltiazem HCl supply chain is multi-source at the API level, while FDF manufacturing is site-specific and label-dependent.
FAQs
- Which FDA listing fields determine the manufacturer-of-record for TIAZAC?
- How can I map a TIAZAC NDC to its labeler and manufacturing site?
- Do TIAZAC capsules use gelatin or HPMC shells, and does it vary by lot?
- What typically causes TIAZAC supply interruptions in diltiazem HCl capsules?
- How do labeler transitions (CMO changes) show up in FDA drug listings for TIAZAC?
References (APA)
- U.S. Food and Drug Administration. (n.d.). Drug listing and Orange Book resources for proprietary and generic drug products (diltiazem hydrochloride). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
