Suppliers and packagers for dopram

dopram

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma	DOPRAM	doxapram hydrochloride	INJECTABLE;INJECTION	014879	NDA	Hikma Pharmaceuticals USA Inc.	0641-6018-01	20 mL in 1 VIAL (0641-6018-01)	1965-06-23
Hikma	DOPRAM	doxapram hydrochloride	INJECTABLE;INJECTION	014879	NDA	Hikma Pharmaceuticals USA Inc.	0641-6018-06	6 VIAL in 1 CARTON (0641-6018-06) / 20 mL in 1 VIAL (0641-6018-01)	1965-06-23
Hikma	DOPRAM	doxapram hydrochloride	INJECTABLE;INJECTION	014879	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1404-1	1 VIAL in 1 CARTON (51662-1404-1) / 20 mL in 1 VIAL	2019-10-19

DOPRAM Drug Suppliers: Who Manufactures and Supplies Doxapram (API, Finished Dose, and Licensed Sources)

Last updated: May 24, 2026

DOPRAM is the brand name for doxapram hydrochloride (a respiratory stimulant). Supplier and manufacturing coverage depends on the market, dosage form, and regulatory filing (NDC/manufacturer assignment). Public distributor and manufacturer visibility is typically strongest through FDA Orange Book-linked product entries, NDC labeling, and wholesaler sourcing catalogs.

Which companies supply DOPRAM (doxapram) in the US market?

DOPRAM is sourced through finished-dose manufacturers and authorized distributors. In practice, the “supplier” most relevant to procurement is the labeled manufacturer of the specific NDC in the FDA database and on the product label.

How to identify the correct DOPRAM “supplier” for procurement

A procurement team typically matches one or more of the following:

• Dosage form (commonly injectable for hospital use)
• Strength and package configuration
• NDC number
• Labeler/manufacturer listed on the FDA registration and label

Key procurement reality: NDC-level sourcing

Different NDCs can reflect different labeled manufacturers even when the active ingredient is the same. Supplier checks should be NDC-specific, not brand-wide.

What is the supply chain structure for Doxapram hydrochloride (DOPRAM)?

Doxapram supply breaks into two tiers:

1. API and key intermediates (doxapram hydrochloride synthesis, salt formation, and QC release)
2. Finished dosage manufacturing (drug product compounding, sterilization if applicable, filling, and final QC release)

Common supplier roles (by function)

• Finished-dose manufacturer (drug product): produces and labels the NDC
• Contract manufacturing organizations (CMOs): may fill, finish, or batch-release for the NDA holder
• API manufacturers: sell doxapram hydrochloride to drug product sites under supply agreements
• Wholesalers and GPO channels: distribute the NDC through hospital procurement ecosystems

Which suppliers provide Doxapram API (active pharmaceutical ingredient) for DOPRAM?

API suppliers are typically identified through:

• Drug Master File (DMF) cross-references in approved application records
• FDA manufacturing site listings tied to the NDA
• Public confirmations in procurement documentation and audits

How many suppliers exist for DOPRAM (doxapram) and what are the concentration risks?

Doxapram is a niche hospital drug in many markets. The supplier base can be narrow due to:

• specialized manufacturing and release requirements
• limited demand compared with high-volume injectables
• cost and compliance burden

Procurement risk is typically assessed by:

• number of labeled finished-dose manufacturers
• degree of single-site dependency
• historical evidence of shortages or allocation

When does DOPRAM lose exclusivity, and how does that change supplier availability?

DOPRAM’s supplier universe changes when:

• patents expire and generics enter
• changes in FDA exclusivity (if any is applicable to the relevant product entry)
• NDA lifecycle events (re-registrations, manufacturing site changes)

To map this precisely, the supply timeline must be tied to the Orange Book entries for the specific drug product/NDC.

What is the Orange Book status of DOPRAM (doxapram) and which patents cover it?

Orange Book status and patent coverage determine whether:

• branded supply faces generic competition
• any “authorized” generics or AB-rated products are present

Patent mapping is usually performed at the drug product active ingredient level plus dosage form to capture formulation and method-of-use coverage.

Which generic or authorized products compete with DOPRAM and who supplies them?

If one or more AB-rated generics exist for doxapram HCl injection (or the same dosage form), their suppliers are identified by:

• Orange Book drug product entries
• NDC labeler/manufacturer names
• ANDA holder/manufacturer listings

Supplier competition usually expands at the generic product level even if the API market remains concentrated.

What patent litigation or Paragraph IV challenges affect DOPRAM suppliers?

Supplier entry in the doxapram space can be influenced by:

• ANDA Paragraph IV litigation (if Orange Book patents exist and are challenged)
• settlement agreements that delay generic supply
• injunctions affecting market entry

Mapping litigation requires tying to the specific Orange Book patents associated with the relevant drug product entry.

What manufacturing/IP barriers can limit additional DOPRAM suppliers?

Common barriers that restrict supply diversification:

• complex sterility assurance and validated manufacturing processes
• tight QC release specifications for small-volume injectables
• reliance on particular API vendors or single upstream synthesis routes
• regulatory data exclusivity or patent enforcement on specific formulations/processes

What dosing forms of DOPRAM affect which suppliers can manufacture it?

Supplier feasibility is driven by:

• dosage form (injectable presentation)
• strength and container closure system
• required compendial quality attributes
• labeling configuration

Procurement should align to the exact presentation used at the facility to avoid substituting a non-equivalent NDC.

Where can procurement teams source DOPRAM reliably (wholesaler vs direct-to-hospital)?

Reliable sourcing generally comes from:

• GPO and contracted wholesalers for hospital fulfillment
• direct manufacturer/distributor agreements (common for specialty or allocation-prone products)
• NDC-authorized distributor lists used by supply chain compliance

A key operational step is confirming:

• lot traceability
• expiration dating
• cold-chain requirements (if any, depending on product label instructions)

Key tables for supplier mapping (NDC and labeler level)

The most actionable view for supplier decisions is NDC-by-NDC, since procurement contracts and availability track by NDC.

Table: DOPRAM supplier mapping template (fill with NDC-specific labeler/manufacturer names) | Market | Dosage form | Strength | NDC | Labeler/Manufacturer (site) | NDA/ANDA reference | Primary distributor channels | |---|---|---:|---|---|---|---| | US | Injectable | (as labeled) | (NDC) | (manufacturer) | (NDA/ANDA) | (GPO/wholesalers) |

What is the commercial exposure if DOPRAM supply is constrained?

Exposure is assessed by:

• how often the hospital uses doxapram for respiratory indications
• whether alternative agents exist in the institution’s formulary
• historical allocation rates and substitution policies

Constrained supply often drives:

• procurement re-forecasting
• inventory safety stock decisions
• increased reliance on alternative stimulants depending on clinical protocols

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Key Takeaways

• “Supplier of DOPRAM” should be treated as NDC-specific labeled manufacturer, not a single brand-level entity.
• Doxapram supply is split across API upstream and finished-dose drug product manufacturing, with procurement risk typically tracking the number of finished-dose labelers.
• Changes in supplier availability usually follow generic approvals, site changes, or market authorization shifts tied to Orange Book/NDC listings.
• Patent and exclusivity status can block or delay new finished-dose entrants, affecting supply diversity.

FAQs

1. How do I find the labeled manufacturer for DOPRAM by NDC?
2. Are there FDA-approved generic versions of doxapram hydrochloride injection, and who supplies them?
3. What is the difference between doxapram API suppliers and DOPRAM finished-dose suppliers?
4. How do shortages or allocations of doxapram typically affect hospital procurement channels?
5. What manufacturing site changes for the DOPRAM NDC signal supplier churn risk?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-05-24).
2. U.S. Food and Drug Administration. Drugs@FDA. (Accessed 2026-05-24).