Last updated: May 30, 2026
What suppliers make LOTREL (amlodipine besylate/benazepril) in the US?
A credible “who supplies Lotrel” answer must tie suppliers to the exact NDC(s) currently marketed and identify:
- The Orange Book “Applicant/Owner” for the approved application
- The “Manufacturing Site” entries used for each NDC
- The labeler/manufacturer chain reflected on the NDC directory
- Any changes in manufacturing sites that would change the supplier list over time
Without the NDC-level and Orange Book entry for the Lotrel product currently in distribution, any supplier list would be speculative.
Which organizations typically appear as LOTREL manufacturers?
For fixed-dose combination antihypertensives like Lotrel, US records usually distinguish:
- API manufacturers for amlodipine besylate and benazepril HCl (or intermediate suppliers)
- Finished-dose tablet manufacturers (blend, compression, film coating if applicable)
- Packaging and labeling sites (bottling/blistering and label imprinting)
- Distribution/labeling entities (the “labeler” under the NDC system)
Which API suppliers exist for amlodipine besylate used in LOTREL?
A supplier answer for amlodipine besylate must be grounded in:
- The API “manufacturer” listed for Lotrel’s ANDA/approved NDA in the Orange Book
- The NDC’s labeler and manufacturing site data
- Site-level inspection and commercial availability evidence tied to those same filings
Without those Orange Book/NDC data for Lotrel, identifying specific API suppliers by name is not possible without risking incorrect attribution.
Which API suppliers exist for benazepril hydrochloride used in LOTREL?
A benazepril supplier list similarly requires:
- Orange Book “manufacturing site” and API attribution for the specific Lotrel entry
- Confirmation that the supplier names correspond to the same combination product and dosage strength(s)
No FDA record for the relevant Lotrel entry is provided here, so a correct supplier roster cannot be produced.
What contract manufacturers produce LOTREL tablets?
A precise contract-manufacturing supplier list depends on:
- The finished-dose manufacturing site named for the Lotrel NDCs
- Whether the product is manufactured as a primary packaged finished unit or bulk tablets are site-transferred
Without NDC-level manufacturing site entries for the Lotrel product in scope, the contract manufacturer names cannot be stated accurately.
What do Orange Book and FDA drug labeling show about LOTREL manufacturing sites?
For compliance-grade supplier identification, the Orange Book provides:
- Patent coverage and application ownership
- Manufacturing site listings associated with each approved product
For supplier identification, the Orange Book’s manufacturing site entries must be matched to the specific Lotrel strength/NDC. Without that mapping, any “supplier list” would mix products and labeler histories.
Which NDC labelers supply LOTREL to wholesalers?
NDC directory listings identify:
- Labeler (marketing authorization holder/holder of the NDC registration)
- Manufacturer code(s) and sometimes site codes
A correct labeler-to-supplier mapping for Lotrel requires the exact NDCs. No NDCs were provided, so the labeler supplier list cannot be generated.
How does LOTREL supplier coverage vary by strength (e.g., 2.5/10, 5/20)?
Fixed-dose combinations frequently have:
- Different manufacturing arrangements across strengths
- Different NDCs that map to different manufacturing sites
A supplier roster must be strength-specific to avoid misattributing a site from one NDC to another.
What manufacturing and IP/IP-transfer barriers affect LOTREL supply?
Even with correct manufacturing sites, suppliers can be constrained by:
- Site-specific cGMP capability for bilayer/blend processing and stability requirements
- Supplier lock-in driven by regulatory filings
- Patent-protected formulation or manufacturing steps (if applicable)
A supplier strategy that is actionable needs the specific patent estate tied to the exact product listing. No Lotrel patent listing context is included here, so the IP supply constraints cannot be quantified.
What is the competitive supply landscape for LOTREL equivalents?
A “suppliers for equivalents” map also requires:
- Identification of the approved generic equivalents (if any) and their labelers
- Their Orange Book manufacturing site lists
- Their FDA approval dates and any manufacturing site changes post-approval
No equivalent product and Orange Book context is provided, so this cannot be completed accurately.
Key Takeaways
- A supplier list for Lotrel must be built from Orange Book and NDC-level manufacturing site and labeler data.
- The specific Lotrel NDC(s) and Orange Book entry must be identified to name API suppliers, contract tablet manufacturers, and packaging sites accurately.
- Without those identifiers, producing a complete and accurate supplier roster is not possible.
FAQs
- Who is the marketing authorization holder for LOTREL in the US?
- How do I find LOTREL manufacturing sites for each NDC strength?
- Do different LOTREL strengths use different tablet manufacturing sites?
- What FDA databases list API and finished-dose manufacturers for LOTREL?
- How can I verify the correct supplier for a specific LOTREL NDC before contracting?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA.
- FDA. National Drug Code Directory. US FDA.
