Suppliers and packagers for EPANED

EPANED

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	EPANED	enalapril maleate	SOLUTION;ORAL	208686	NDA	Wilshire Pharmaceuticals, Inc.	52536-401-01	1 BOTTLE in 1 CARTON (52536-401-01) / 150 mL in 1 BOTTLE	2024-04-08
Azurity	EPANED	enalapril maleate	SOLUTION;ORAL	208686	NDA	Azurity Pharmaceuticals, Inc.	52652-4001-1	150 mL in 1 BOTTLE (52652-4001-1)	2016-10-03
Azurity	EPANED	enalapril maleate	SOLUTION;ORAL	208686	NDA AUTHORIZED GENERIC	Amneal Pharmaceuticals NY LLC	69238-2141-7	1 BOTTLE in 1 CARTON (69238-2141-7) / 150 mL in 1 BOTTLE	2022-03-23

Suppliers and packagers for EPANED

Last updated: June 8, 2026

EPANED (enalapril; enalapril maleate) suppliers and manufacturing footprint: Who makes it, who supplies it, and what to verify in the supply chain

EPANED is the brand for oral enalapril (enalapril maleate) in the US. Under current US distribution, the most direct way to identify “suppliers” is to map (1) the FDA label manufacturer and (2) the firms listed on the Drug Shortages System/labeling and (3) the NDA “applicant” and listed drug (RLD) manufacturing sites shown in FDA resources (Orange Book and label).

For EPANED specifically, the supplier set is typically limited to the NDA’s listed manufacturers plus any contract manufacturers authorized for commercial supply. Without the exact NDA label/manufacturer block for the specific strength and dosage form, a complete supplier list cannot be stated accurately.

What are the approved EPANED manufacturers listed on the label?

Fast answer: EPANED’s “manufacturer/sponsor” should be pulled from the package insert (US prescribing information) for each strength (tablets are typically specified by label section). That label block is the authoritative supplier listing for commercial distribution in the US.

H3: Which firms appear as “Manufactured for” or “Distributed by” on EPANED cartons and labeling?

EPANED packaging and the prescribing information typically include lines such as:

• “Manufactured for” (labeler)
• “Distributed by” (market sponsor)
• “Manufactured by” (site manufacturer)

These fields are the practical definition of “supplier” for procurement and KOL/market access work because they drive:

• GMP responsibility for commercial lots
• NDA responsibility chain
• traceability for recalls and supply failures

Who is the NDA holder/applicant for EPANED in the US?

Fast answer: The NDA applicant is the correct “origin” firm for the brand and is the entity against which Orange Book patent listings and regulatory actions are mapped.

H3: Why the NDA applicant matters for supplier mapping

When you license, challenge, or qualify alternative sources, you need:

• the NDA applicant and its approved manufacturing arrangements
• any site changes in prior supplements
• labeler changes that do not necessarily change the manufacturing entity

What is the Orange Book listing status of EPANED and what does it imply for generic supply?

Fast answer: EPANED’s Orange Book listing status affects whether generics can be sourced immediately and whether supplier diversity increases during exclusivity windows.

H3: How Orange Book listings relate to “suppliers”

Orange Book does not directly list contract manufacturers by name for every commercial lot. It links:

• the listed drug
• patent and exclusivity data
• applicant/labeler structures

For supplier identification, Orange Book is a starting index. The supplier list still comes from:

• the current US label
• FDA label databases
• submission history and manufacturing supplements

When does EPANED supply change based on manufacturing site updates or labeler changes?

Fast answer: Supplier changes happen when the applicant files a manufacturing site change supplement, line extension, or labeling change. In practice, you track them through:

• label version history
• recent FDA supplements
• inspection outcomes tied to manufacturing sites (when publicly reported)

H3: Typical triggers for supplier switching in oral generics and branded generics

• site capacity constraints
• raw material lead-time shifts for API and excipients
• stability/packaging line qualification for tablets
• contract manufacturer changes for cost or throughput

How do you identify reliable EPANED suppliers for procurement and contracting?

Fast answer: Use a two-layer verification: (1) the current EPANED label manufacturer/distributor block and (2) lot-level documentation from the specific NDC you procure.

H3: Procurement checklist aligned to pharma quality systems

• Confirm the NDC and strength match the exact label you will reference.
• Verify “manufactured for” and “manufactured by” fields on the latest carton labeling.
• Require Certificate of Analysis (CoA) and lot traceability matching the NDC.
• Confirm the supplier’s quality agreement coverage for manufacturing site and change control.

Which API and excipient suppliers are tied to EPANED production?

Fast answer: API and excipient suppliers are not consistently disclosed in public FDA labeling. In many cases, enalapril maleate and excipients are supplied through a commercial chain where the brand labeler/manufacturer names the finished-goods site, not the upstream API vendor.

H3: What you can and cannot verify from public sources

• Finished-goods manufacturer and labeler: verifiable from labeling and FDA resources.
• Upstream API supplier identities: often not fully disclosed publicly.

Competitive landscape: How does EPANED sourcing compare with other enalapril brands and generics?

Fast answer: Enalapril (enalapril maleate) is widely available. Supplier diversity is higher for generics; EPANED supply is constrained to labeler/manufacturer arrangements approved under its NDA plus any authorized distribution partners.

H3: What “supplier risk” usually looks like for enalapril oral tablets

• concentration of finished-goods supply among a small number of tablet GMP sites
• API lead-time pressure during capacity disruptions
• generic substitution shifting demand and stressing the remaining qualified supply base

Key takeaways

• EPANED “suppliers” in the operational sense are the labeler/manufacturer entities named in the current US prescribing information and carton labeling for the specific NDC/strength.
• Orange Book supports regulatory mapping, but it does not by itself provide a complete, lot-accurate supplier list for every strength.
• Upstream API/excipient suppliers typically require commercial qualification and lot documentation because they are not consistently disclosed in public regulatory artifacts.

FAQs

1. How do I confirm EPANED’s current labeler and manufacturer for a specific NDC/strength?
   Use the latest US prescribing information and carton labeling for that NDC/strength; match the “manufactured for” and “distributed by” fields.

2. Does Orange Book list the contract manufacturer sites for EPANED?
   Usually not comprehensively; it primarily lists the drug, patents, and exclusivity against the NDA applicant/labeler structure.

3. What documents are most important to verify EPANED supply reliability?
   Lot-level CoA, traceability, and the executed quality agreement covering the named finished-goods manufacturing site.

4. Are EPANED and enalapril generics interchangeable at the supplier level?
   They are interchangeable clinically when AB-rated, but supplier identity depends on the specific NDC and approved manufacturing arrangements.

5. How can I track EPANED supplier changes over time?
   Track label revisions and manufacturing supplement history for the NDA, then verify at procurement with lot documents for the exact NDC/strength.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book).
2. FDA. DailyMed. EPANED (enalapril) labeling and product information. (DailyMed).