DEMEROL: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	DEMEROL	meperidine hydrochloride	INJECTABLE;INJECTION	021171	NDA	Hospira, Inc.	0409-1176-30	10 CARTRIDGE in 1 CARTON (0409-1176-30) / 1 mL in 1 CARTRIDGE (0409-1176-03)	2005-08-25
Hospira	DEMEROL	meperidine hydrochloride	INJECTABLE;INJECTION	021171	NDA	Hospira, Inc.	0409-1178-30	10 CARTRIDGE in 1 CARTON (0409-1178-30) / 1 mL in 1 CARTRIDGE (0409-1178-03)	2005-09-13
Hospira	DEMEROL	meperidine hydrochloride	INJECTABLE;INJECTION	021171	NDA	Hospira, Inc.	0409-1179-30	10 CARTRIDGE in 1 CARTON (0409-1179-30) / 1 mL in 1 CARTRIDGE (0409-1179-03)	2005-10-12
Hospira	DEMEROL	meperidine hydrochloride	INJECTABLE;INJECTION	021171	NDA	Hospira, Inc.	0409-1181-30	1 VIAL, MULTI-DOSE in 1 CARTON (0409-1181-30) / 30 mL in 1 VIAL, MULTI-DOSE	2006-02-24
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 26, 2026

Demerol (meperidine; opioid analgesic, hydrochloride salts) supply is dominated by incumbent and specialty generic manufacturers that produce sterile injectables under cGMP and controlled-substance handling requirements. The practical “supplier” landscape splits into (1) API producers and (2) finished-dose manufacturers/distributors (including authorized generics), with third-party logistics and pharmacy channel distribution as the operational layer.

What follows is a structured supplier map by supply node: API, finished-dose manufacturers, and known distribution channels through major pharmaceutical wholesalers.

Who manufactures demerol (meperidine) injection and tablets in the US?

Demarol is not a single standardized “brand” supply anymore in practice because most retail availability today comes through generic meperidine hydrochloride products in sterile injection formats and, in some markets, oral tablets. US supply typically flows from a limited set of sterile manufacturing sites that also support DEA-controlled substance distribution.

Finished-dose “supplier” categories

Generic drug manufacturers (ANDA holders) producing meperidine hydrochloride injection (and, where applicable, tablets).
Authorized distributors / national wholesalers fulfilling channel orders to pharmacies and hospitals.
Hospital supply contracts managed by group purchasing organizations (GPOs), which may concentrate procurement to specific approved SKUs and manufacturers.

Sterile injection manufacturing constraints that limit suppliers

Aseptic processing and terminal sterilization qualification for controlled-substance SKUs.
DEA registration for manufacturing and distribution of opioids.
Tight lot traceability and diversion controls.

Which companies supply demerol (meperidine) API and bulk drug substance?

API supplier lists for meperidine hydrochloride are typically not publicly consolidated in a single authoritative dataset. API procurement is often handled through:

controlled-substance bulk chemical supply agreements,
long-term supply contracts with DEA-registered entities,
and second-source strategies managed at the distributor or finished-dose manufacturer level.

API supply “shape”

Meperidine API is produced by a small set of chemical manufacturers with opioid chemical handling capability.
Finished-dose manufacturers frequently qualify multiple API sources to mitigate shortages and batch failures.

How to identify API suppliers in practice

Look to Drug Master File (DMF) holders referenced by ANDAs and supplements.
Match ANDA manufacturer to likely API source qualification packages during supplier audits.
Use FDA facility and DMF references as the most direct public linkage mechanism.

What is the Orange Book status of demerol (meperidine) and how does it affect supplier choice?

For “Demerol” as a brand label, the modern supplier reality is driven by the Orange Book listing(s) for meperidine hydrochloride dosage forms. Orange Book status determines:

whether products are under active exclusivity,
whether generics can legally enter via abbreviated pathways,
and whether multiple manufacturers can compete.

What to expect on Orange Book

Multiple ANDA entries for different strengths and dosage forms.
Periodic supplements for manufacturing site changes and formulation/process updates.

Supplier impact

If several ANDA holders exist for injection strengths, supplier diversity is higher at the finished-dose level.
If fewer ANDAs exist for specific strengths or routes, channel availability can concentrate.

When does meperidine (demerol) lose exclusivity and what does that mean for new supplier entry?

Meperidine has been marketed for decades, so supplier entry is usually constrained less by new exclusivity and more by:

controlled-substance manufacturing capacity,
sterile facility readiness,
and regulatory maintenance of ANDAs/DMFs.

Typical entry drivers after patent/exclusivity

ANDA maintenance and site transfer execution.
DMF availability and API qualification.
DEA manufacturing authorization and inspection readiness.

Which generic manufacturers sell meperidine hydrochloride injection that substitutes for Demerol?

In-market substitutes for Demerol are generic meperidine hydrochloride injection products. Supplier identification requires mapping:

ANDA holder to NDC for each strength,
sterile facility producing that NDC,
and distribution via national wholesalers and hospital systems.

Operational reality

Many hospitals stock by NDC and lot through contracted distributors.
Shortages often impact a subset of NDCs linked to specific sites.

What patent estate covers demerol (meperidine) and how does it shape supplier competition?

Because meperidine is an older molecule, supplier competition is often not materially limited by active brand patents. The more relevant IP barriers tend to be:

formulation-specific changes (rare for immediate-release opioid solutions),
manufacturing method patents (if any remain),
and regulatory exclusivities tied to specific applications rather than the molecule.

Where patent protection still matters

If a particular supplier holds a formulation or manufacturing-process patent still in force,
it can delay ANDA approval for certain strengths or process variations.

What litigation or DEA enforcement affects the meperidine supplier base?

Opioid supply can be disrupted by:

DEA quota/allocation and enforcement actions affecting controlled-substance distribution,
manufacturing shutdowns from cGMP compliance issues,
consent decrees impacting facilities or sites.

Supplier risk

A small number of sterile sites means localized enforcement can reduce total supply quickly.

How do wholesale distributors source demerol (meperidine) and manage shortages?

Most US distribution of controlled opioids uses a layered supply chain:

Manufacturer produces and packages.
Authorized distributor / wholesaler receives and warehouses under DEA controls.
Wholesaler to provider (hospitals, pharmacies) via contracted channels.
GPO and contract terms determine primary stocking and allocation.

Shortage handling

Allocation by wholesaler or manufacturer when demand exceeds supply.
Substitution to alternate NDCs or strengths (when clinically acceptable and inventory exists).
Temporary reprioritization of contracts and customers.

Which distribution channels reliably provide demerol substitutes for hospitals and pharmacies?

Hospitals and institutional pharmacies typically rely on:

national wholesalers for primary sourcing,
GPO-linked distribution for contract pricing,
and emergency replenishment channels during shortages.

At the channel level, supplier diversity is often constrained more by:

contract eligibility,
lot traceability,
and allocation policy than by manufacturing capability alone.

How does international supply compare for demerol (meperidine) API and finished dose?

International supply varies by:

local regulatory approvals for meperidine dosage forms,
national opioid controls and licensing,
sterile manufacturing capacity for injectables.

Where US supply is tight, firms sometimes source via international distributors, but controlled-substance importation adds friction:

DEA import approvals,
customs and licensing,
and quality system alignment.

Key supplier intelligence checklist for demerol (meperidine) sourcing decisions

Confirm exact NDC and dosage form (injection vs tablets) to avoid false equivalence.
Map finished-dose manufacturer to sterile site because shortages often track by facility.
Validate DEA registration and controlled-substance handling in the supplier’s distribution model.
Use Orange Book to confirm which ANDA holders are active for the target NDCs.
Track cGMP inspection outcomes for the manufacturing sites behind those NDCs.

Key Takeaways

Demerol (meperidine) supply is primarily an injectable generic market at the finished-dose level, with supplier availability driven by sterile cGMP capacity and controlled-substance logistics.
API supplier identification is indirect and typically tied to DMF references and ANDA qualification packages rather than public vendor directories.
Practical “supplier choice” for hospitals and distributors hinges on NDC-level manufacturer mapping, contract channels, and shortage allocation behavior.

FAQs

Which NDCs are closest substitutes for Demerol (meperidine) injection in US hospitals?
How do DEA quotas and allocation rules affect meperidine hydrochloride availability during shortages?
What cGMP inspection findings most commonly reduce supply of sterile opioid injectables like meperidine?
How can a buyer verify the manufacturing site and quality system behind a specific meperidine injection NDC?
Do meperidine tablets and injection share the same suppliers and manufacturing risks?

References (APA)

FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
FDA. Drug Shortages. U.S. Food and Drug Administration.
FDA. Drug Master Files (DMF) information. U.S. Food and Drug Administration.
DEA. Controlled Substances. U.S. Drug Enforcement Administration.

Suppliers and packagers for DEMEROL

DEMEROL

Demerol (meperidine) Suppliers: API Manufacturers, Finished-Dose Sources, and Contract Manufacturing for Injection and Tablets