Suppliers and packagers for TRANDOLAPRIL

TRANDOLAPRIL

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	TRANDOLAPRIL	trandolapril	TABLET;ORAL	078438	ANDA	Rising Pharma Holdings, Inc.	57237-089-01	100 TABLET in 1 BOTTLE (57237-089-01)	2007-06-12
Aurobindo Pharma	TRANDOLAPRIL	trandolapril	TABLET;ORAL	078438	ANDA	Rising Pharma Holdings, Inc.	57237-090-01	100 TABLET in 1 BOTTLE (57237-090-01)	2007-06-12
Aurobindo Pharma	TRANDOLAPRIL	trandolapril	TABLET;ORAL	078438	ANDA	Rising Pharma Holdings, Inc.	57237-091-01	100 TABLET in 1 BOTTLE (57237-091-01)	2007-06-12

Who Supplies Trandolapril to the Pharma Market?

Last updated: April 25, 2026

Trandolapril is an established ACE-inhibitor marketed globally in tablets (typically in the range of 1 mg and 2 mg strengths). Supply for trandolapril across the value chain falls into two buckets: (1) active pharmaceutical ingredient (API) manufacturing and (2) finished-dose (FDF) drug product manufacturing. The market is serviced by both vertically integrated large generics players and specialized API producers, with typical procurement paths that include DMFs filed to multiple regulators and distribution via wholesalers and authorized distributors.

Which suppliers provide trandolapril API?

Trandolapril API is sourced through suppliers that hold relevant regulatory documentation (for example, Drug Master Files where applicable), routinely supply multiple dosage formats downstream, and support ANDA and/or registered product dossiers in target markets. In practice, purchasers screen for:

• Consistent API quality and impurity profiles aligned to pharmacopeial monographs (and dossier specifications)
• GMP manufacturing with inspection history in line with target regulators
• Ability to deliver controlled changes (manufacturing site transfers, process validation updates, analytical method updates)

Common supplier archetypes in trandolapril API supply

• Global generics API manufacturers with multi-product ACE inhibitor portfolios and established DMF coverage
• Specialty API manufacturers focused on cardiovascular building blocks and chiral or process-sensitive APIs
• Contract manufacturers supporting commercial-scale campaigns under master supply agreements

Which companies supply finished-dose trandolapril tablets (FDF)?

Finished-dose trandolapril is supplied in many markets by generic and brand manufacturers through national regulatory registrations. Buyers typically evaluate:

• Market authorization status in the destination country (marketing authorization holder)
• Product strength, dosage form, packaging configuration, and shelf-life
• Bioequivalence positioning and regulatory history (where applicable)

Typical FDF supply coverage pattern

• Multi-market generics firms supply multiple strengths and package configurations
• Local distributors handle tendering and government procurement (where the local payer model requires it)
• Parallel trade markets may draw from multiple primary marketing authorizations, depending on local rules

What procurement and regulatory signals matter for trandolapril sourcing?

For procurement teams, trandolapril sourcing decisions are usually anchored to three verifiable pillars:

1. Regulatory dossier readiness

   • API: DMF or equivalent dossier documentation to support the purchaser’s drug product registration
   • FDF: marketing authorization and approved labeling for the target market

2. GMP compliance at supply sites

   • Inspection outcomes and manufacturing site stability
   • Demonstrated ability to maintain impurity controls and process consistency

3. Commercial reliability

   • Lead times, minimum order quantities, and supply continuity provisions
   • Ability to handle discontinuations, change controls, and requalification cycles

How to map suppliers efficiently for trandolapril in due diligence

A fast, data-driven supplier mapping usually uses the following evidence set:

• Regulatory listing crosswalk
  • Compare registered FDF labels by strength and dosage form to identify likely manufacturers and marketing authorization holders
• DMF cross-references
  • Link API suppliers to drug product dossiers referencing their API documentation
• Quality documentation
  • Certificates of Analysis consistency, batch release patterns, and pharmacopeial compliance history
• Supply chain artifacts
  • Distributor authorization status, cold-chain requirements (typically not applicable for tablets, but packaging integrity matters), and serialization needs (where mandated)

Market-facing supplier identification: what to expect by region

Supply coverage for trandolapril differs by region due to registration timelines, patent/market exclusivity transitions, and tendering structures.

North America

• FDF supply is dominated by large generics firms and their contract manufacturing networks.
• API sourcing often routes through established DMF-supported API manufacturers with broad cardiovascular portfolios.

Europe

• Tendering and pharmacy channel distribution drive vendor selection.
• FDF supply is split among major generics brands, local portfolio holders, and authorized wholesalers.

Emerging markets and government procurement

• Supplier selection is frequently influenced by registration status, documentation readiness, and bid pricing.
• API availability can be constrained by inspection outcomes and supply campaign scheduling.

Key takeaways

• Trandolapril supply is split across API manufacturers (typically DMF-supported) and finished-dose drug product manufacturers (market authorization holders).
• Due diligence should anchor on regulatory documentation linkage, GMP inspection history, and commercial continuity.
• Effective supplier mapping pairs FDF labeling/authorization evidence with API dossier cross-references to reduce misattribution risk in procurement.

FAQs

1) Are trandolapril API suppliers the same as trandolapril tablet manufacturers?

Not usually. API is typically produced by specialized API sites, then used by one or more FDF manufacturers who hold product authorizations.

2) What proof is most important when selecting an API supplier for trandolapril?

Regulatory dossier readiness (DMF or dossier equivalent), consistent impurity control aligned to specifications, and validated GMP manufacturing at the listed site.

3) Do trandolapril tablets require cold-chain logistics?

Typically no for standard compressed tablets, but packaging integrity, desiccant use where needed, and serialization/label compliance still matter.

4) How do procurement teams confirm which supplier made a specific FDF batch?

By matching batch records and distributor/manufacturer documentation to the registered marketing authorization and the listed manufacturer on labeling and regulatory filings.

5) What can disrupt trandolapril supply even when registration exists?

GMP inspection outcomes, API site changes, impurity excursions during process changes, or manufacturing campaign scheduling constraints.

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References

1. United States Pharmacopeia (USP). USP monograph: Trandolapril and related substances (latest edition).