Suppliers and packagers for generic pharmaceutical drug: MEPERIDINE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE

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

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

Suppliers for Meperidine Hydrochloride (API and Finished Dose): Who Makes It, What They Supply, and What Regulated Channels Matter

Last updated: May 23, 2026

Meperidine hydrochloride (API and generics of the finished drug) is supplied through a mixed base of active ingredient manufacturers and multiple branded/generic finished-dose labelers. The supplier landscape is fragmented and varies by geography, strength, and dosage form (commonly injection; oral forms are less prevalent today).

Which companies supply meperidine hydrochloride API and finished drug products?

Fast answer: Meperidine hydrochloride is typically sourced from specialized API producers and finished-dose generic manufacturers that list the product on FDA records and sell through wholesalers. The practical supply chain is dominated by generic injectables and contract manufacturing organizations (CMOs) that produce under labeler agreements.

API suppliers: typical supply structure

Meperidine hydrochloride API is usually supplied as:

• Generic chemical API (for injectable dosage forms).
• Non-sterile intermediates by upstream specialty chemical firms, then finished API by dedicated API plants.
• Sterile finished dosage manufacturing handled by separate sterile injectables sites, with API supplied as a primary input.

Finished-dose suppliers (labelers/manufacturers)

Finished-dose “suppliers” for meperidine hydrochloride are generally the FDA labeler/manufacturer of record for each NDC and strength, with distribution through:

• National wholesalers (US market)
• Hospital/IDN distribution programs
• Tender/contract supply where formularies specify product and labeler

What matters for selecting a supplier

For procurement and regulatory risk control, suppliers are screened on:

• Current Good Manufacturing Practice (cGMP) compliance
• Sterile manufacturing capability (for injectable products)
• DMF/USDMF status and ability to support regulatory filings
• Certificate of Analysis (CoA) consistency by lot
• Packaging configuration and NDC/strength coverage
• Supply continuity and change control (site, process, or API sourcing)

What is the FDA regulatory status of meperidine hydrochloride, and how does it affect supplier choice?

Fast answer: Meperidine hydrochloride has an established FDA presence via approved finished products and applicable drug listing pathways. Supplier selection in the US is driven by which finished products are currently marketed under specific NDCs and which firms hold manufacturing responsibility for those products.

How FDA records map to “suppliers”

For a procurement team, the operational supplier is:

• The manufacturer of record and/or labeler for each NDC.
• The API supplier is often not visible at the public-facing labeler level, unless a USDMF or specific supply chain disclosure appears in regulatory documentation.

DMF and USDMF implications

If you are qualifying suppliers for commercial manufacturing or tender supply, you rely on:

• Whether the API is supported by a USDMF (for standard information transfer)
• Whether the finished-dose manufacturer is prepared to support:
  • CMC comparability expectations
  • change notifications
  • regulatory cross-referencing where permitted

What suppliers can provide meperidine hydrochloride injections, and which dosage strengths dominate supply?

Fast answer: In the current market, meperidine hydrochloride is primarily encountered as injectable strengths (commonly 25 mg/mL, with other strengths also present historically). Supplier availability depends on which NDCs are actively marketed and their current manufacturing sites.

Injection supply constraints

Injectables require:

• Sterile filtration/aseptic processing or terminal sterilization (as applicable)
• Controlled particle burden and bioburden limits
• Robust container-closure qualification

These constraints narrow the pool of finished-dose suppliers versus oral chemical products.

NDC-level supplier mapping

In practice, the supplier roster is built by:

1. Identifying the active NDCs for meperidine hydrochloride injection.
2. Mapping each NDC to its labeler/manufacturer of record from FDA records.
3. Determining which of those manufacturers can support:
   • US hospital distribution timelines
   • BUD/expiry expectations
   • lot release documentation needs

How do generic meperidine hydrochloride suppliers compete: ANDA vs. legacy approvals?

Fast answer: Most supplier competition comes from generic injectable products with ANDA-based supply. Procurement tends to favor suppliers with consistent lot availability and shorter lead times rather than solely the lowest price.

What to check in supplier qualification

• Market availability by strength and package
• Backorder frequency
• FDA inspection history risk signals (for the manufacturing site)
• CMC change control discipline
• Ability to support purchasing specs (concentration, packaging, labeling)

What patent or exclusivity constraints affect supplier entry for meperidine hydrochloride?

Fast answer: Meperidine hydrochloride is an older opioid with established history; supplier entry is typically constrained less by active new exclusivity and more by manufacturing capability, DEA-controlled substance compliance, and CMC/regulatory readiness for injectable products.

Practical “entry barriers” for suppliers

Even when patents do not block entry, suppliers face:

• Sterile injectables manufacturing readiness
• DEA import/manufacturing registration processes (for controlled substances)
• Supply chain reliability for API
• Labeling and controlled-substance distribution compliance

How does controlled-substance regulation affect meperidine hydrochloride suppliers?

Fast answer: Meperidine hydrochloride is subject to controlled-substance requirements. Supplier eligibility depends on whether the firm can lawfully manufacture, distribute, and hold the product under applicable controlled substance registrations.

Supplier compliance checkpoints

• DEA registration scope for manufacturing and distribution
• Warehouse and distribution controls
• Lot-level traceability and documentation
• Reporting and record retention compliance

These requirements typically reduce the supplier pool and make supplier onboarding slower than for non-controlled products.

What does the supplier landscape look like by geography (US vs. non-US)?

Fast answer: US supply is driven by firms that are listed for specific NDCs and can sell through US channels while maintaining DEA compliance. Non-US supply may offer API and contract manufacturing but does not automatically translate into accessible US finished-dose product availability.

US buyers: what to prioritize

• Finished-dose manufacturers with active NDC sales
• Contracting partners able to deliver through authorized distributors
• Suppliers with established hospital procurement workflows

Non-US API sourcing: risk drivers

• Sterile-ready capability gaps (API suppliers do not ship “finished injectable” capability)
• Regulatory filing and DMF support readiness
• Lead times for API and batch certification

What procurement due diligence should buyers run for meperidine hydrochloride sourcing?

Fast answer: Qualification centers on CMC documentation, sterile manufacturing reliability (for injectable), and compliance capacity for a controlled substance.

Buyer checklist for supplier qualification

• Batch CoA with full spec limits and analytical method disclosures
• Sterility assurance documentation for injectable lots
• Change control notices for site/process/API sourcing
• Packaging and labeling verification for US distribution
• On-time delivery history and backorder rates
• Controlled-substance compliance verification (DEA registrations where applicable)

Key Takeaways

• Meperidine hydrochloride supply is dominated by injectable generic finished-dose manufacturers and a set of API suppliers that feed sterile manufacturing supply chains.
• In the US, the practical “supplier list” is defined by NDC-active labelers/manufacturers of record plus DEA-compliant distribution capability.
• Procurement decisions should focus on NDC-level availability, sterile CMC robustness, lot release documentation, and controlled-substance compliance, not only on API supply.

FAQs

1) How can I identify the current FDA-listed manufacturers for meperidine hydrochloride injections?
Use the active NDC entries for meperidine hydrochloride injection to map each NDC to its labeler/manufacturer of record in FDA drug listings.

2) Do meperidine hydrochloride API suppliers also manufacture sterile injectables?
Most API suppliers focus on chemical/API production; sterile finished-dose manufacturing is often performed by separate sterile injectables facilities or CMOs.

3) What documentation do hospital buyers require when sourcing meperidine hydrochloride injection?
Typically CoA, lot traceability, expiry/BUD details, and sterility/quality documentation consistent with sterile injectable requirements.

4) What are the main reasons meperidine hydrochloride injectable products experience supply disruptions?
Sterile manufacturing capacity constraints, controlled-substance compliance complexity, CMC change control events, and API supply lead time.

5) What is the fastest route to qualify a new supplier for a controlled-substance injectable like meperidine hydrochloride?
Qualify based on NDC-active product supply capability, DEA-compliant distribution readiness, and documented CMC/quality performance for sterile injectable lots.

References

1. FDA. Drug products and databases (including drug listing/NDC and related records). U.S. Food and Drug Administration. (Accessed 2026-05-24).