Suppliers and packagers for PRIMATENE MIST

PRIMATENE MIST

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Armstrong Pharms	PRIMATENE MIST	epinephrine	AEROSOL, METERED;INHALATION	205920	NDA	Armstrong Pharmaceuticals, Inc.	17270-5530-0	1 INHALER in 1 CARTON (17270-5530-0) / 160 AEROSOL in 1 INHALER	2018-12-14

Suppliers and packagers for PRIMATENE MIST

Last updated: April 25, 2026

PRIMATENE MIST Suppliers: Who Supplies the Drug and Its Key Inputs?

PRIMATENE MIST is an OTC, pressurized metered-dose inhaler (pMDI) product whose active ingredient is epinephrine (racepinephrine/epinephrine solution). Public supplier lists for the finished dosage form and for each upstream input (API, canisters/valves, propellants, metering components, packaging) are not consistently disclosed in regulatory datasets, and many contracts are private. As a result, there is no single authoritative, complete “supplier roster” for PRIMATENE MIST that can be stated with high confidence from public sources alone.

The most defensible, decision-grade way to identify suppliers is to trace PRIMATENE MIST through (1) the US label holder/manufacturer of record and (2) facility-level manufacturing for NDC strength/form in US FDA drug establishment and inspections datasets, then map upstream inputs via typical inhaler supply chains for pMDI systems. Without verifiable records tied to specific NDCs and strengths for PRIMATENE MIST, producing a complete and accurate supplier list would be speculative, which is not acceptable for R&D or investment use.

What suppliers can be stated from public, label-linked sources?

From the standpoint of supply-chain governance, the only supplier identities that can be stated cleanly are:

• Manufacturer of record (finished product) named on the US product label for the specific PRIMATENE MIST NDC strength/form.
• Contract manufacturing site(s) tied to the product via FDA establishment registration and inspection reporting, mapped to the same drug name and dosage form.
• Packaging system components (canister, valve, actuator) are commonly procured from specialized inhaler component suppliers, but public attribution to PRIMATENE MIST is rarely explicit outside supplier qualification disclosures, which are not part of standard label text.

Which inputs define the supplier map for a PRIMATENE MIST pMDI?

A PRIMATENE MIST-like pMDI supply chain typically includes four upstream supply categories:

1. API and formulation excipients
2. Propellants (pMDI-specific)
3. Inhaler container-closure and metering hardware
   (aluminum or similar canister, metering valve, actuator)
4. Secondary packaging and distribution logistics

For supplier identification, each category requires verifiable linkage to a named product, NDC, and/or manufacturing facility.

What are the procurement targets to audit in supplier selection?

Even when supplier names are not publicly disclosed, audits can be anchored to measurable, supplier-qualification requirements that apply to pMDIs:

• API quality system: GMP compliance for the epinephrine (or racepinephrine) substance used in inhalation dosing.
• Container-closure integrity: compatibility with the formulation and propellant, leak tightness, and corrosion resistance.
• Metering valve performance: dose delivery uniformity and actuation-to-actuation consistency.
• Cold-chain and stability: temperature stress handling for valve seals and formulation stability.
• End-to-end testing: dose content uniformity, spray pattern, plume geometry, delivered dose per actuation, and robustness under storage/transport.

These criteria are what buyers typically use to qualify suppliers even when contractual identities remain private.

Bottom-line answer

A complete, named supplier list for PRIMATENE MIST cannot be produced accurately from public disclosures in a way that meets a high-stakes procurement standard, because supplier identities are not consistently published for:

• upstream API and formulation inputs
• valve/canister actuator component suppliers
• contractor manufacturers tied to the exact NDCs and strengths

Key Takeaways

• PRIMATENE MIST is a pMDI product with epinephrine as the active ingredient; supply-chain mapping requires NDC-specific and facility-specific traceability.
• Public sources generally support only manufacturer of record and facility-level manufacturing data, not a full upstream supplier roster.
• For supplier selection, buyers should qualify pMDI-specific risks: metering valve performance, container-closure integrity, dose uniformity, and formulation-propellant compatibility.

FAQs

1. Is PRIMATENE MIST manufactured by a single supplier worldwide?
   No single worldwide manufacturer can be asserted from public information without tying to specific NDCs and label lots.

2. Can I identify PRIMATENE MIST API suppliers from public databases?
   Not reliably; API sourcing is typically not labeled at the API supplier level.

3. Do inhaler component suppliers (valves/canisters) appear on the product label?
   Usually not; labels name the manufacturer of record rather than specific component suppliers.

4. What is the most defensible way to identify PRIMATENE MIST suppliers?
   Trace from the label’s manufacturer of record to FDA-registered manufacturing establishments for the exact dosage form and NDC strength.

5. What should be prioritized in qualifying PRIMATENE MIST-related suppliers?
   Dose delivery performance, container-closure integrity, compatibility with formulation and propellant, and stability under storage and shipping conditions.

References

[1] FDA. “Drug Establishments and Drugs Manufactured.” US Food and Drug Administration (accessed via FDA drug establishment registration/inspection resources).
[2] FDA. “NDC Directory.” US Food and Drug Administration.
[3] US Prescribing Information/OTC Labeling for PRIMATENE MIST (manufacturer of record and dosage form text as published on marketed packaging).