atropine; pralidoxime chloride: Pharmaceutical manufacturers, suppliers, and distributors

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Us Army	ATNAA	atropine; pralidoxime chloride	INJECTABLE;INTRAMUSCULAR	021175	NDA	Meridian Medical Technologies, LLC	11704-777-01	1 KIT in 1 CARTON (11704-777-01) * .7 mL in 1 SYRINGE, GLASS * 2 mL in 1 SYRINGE, GLASS	2002-01-17
Mmt	DUODOTE	atropine; pralidoxime chloride	INJECTABLE;INTRAMUSCULAR	021983	NDA	Meridian Medical Technologies? LLC	11704-620-01	1 KIT in 1 CARTON (11704-620-01) * 1 POUCH in 1 CARTON / 1 SYRINGE, PLASTIC in 1 POUCH / .7 mL in 1 SYRINGE, PLASTIC * 1 POUCH in 1 CARTON / 1 SYRINGE, PLASTIC in 1 POUCH / 2 mL in 1 SYRINGE, PLASTIC	2006-09-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 30, 2026

Atropine and Pralidoxime Chloride suppliers: key manufacturers, sourcing patterns, and regulatory trackability

What suppliers manufacture atropine for pharmaceutical use in the US and EU?

Answer: Atropine is typically supplied as injectable salts (atropine sulfate in many markets; atropine in other standardized forms) by large sterile-drug manufacturers plus branded generic suppliers. Sourcing is concentrated in CDMO and specialty sterile portfolios that support multi-dose vials and low-volume tox/antidote production runs.

Common drug substance and dosage forms to source

Atropine sulfate injection (commonly supplied in vials for IV/IM/SC use)
Atropine injection used in emergency and hospital settings; sterile, preservative, and container/closure matters
Contract manufacturing often follows finished-dose rather than drug-substance-only procurement for acute-care supply chains

How to validate supplier eligibility for finished-dose procurement

Verify FDA listed drug status for the exact dosage form and strength via the Orange Book record for the relevant NDC (finished product)
Verify sterile manufacturing site is suitable for the product’s regulatory category (parenteral, GMP sterile)
Confirm lot-release testing standards for identity, assay, and sterility consistent with USP/NF monographs

Supplier landscape (sourcing patterns)

Large generic injectables manufacturers supply a meaningful share of atropine vials in North America.
Specialty acute-care and antidote portfolios are supplied by firms that also handle other emergency injectables (antidotes, resuscitation agents, sedation adjuncts).
EU sourcing similarly clusters around GMP sterile injectables producers that export across multiple member states.

Who supplies pralidoxime chloride and pralidoxime-based antidote products?

Answer: Pralidoxime chloride is supplied as an antidote active ingredient and as finished parenteral products in emergency poisonings (notably organophosphate poisoning). Supply is narrower than atropine, with fewer finished-dose manufacturers and higher dependence on specific sterile lyophilized or solution presentations depending on market.

Typical finished-dose presentations

Pralidoxime chloride injection in single-dose vials or ampoules
Strength and salt form matter for substitution: pralidoxime chloride versus related oxime salts (buyers should match the specific product label and strength)

Supplier due diligence checks

Match the NDC/EMA dossier to the exact strength, container type, and administration route (IV/IM depending on label)
Confirm manufacturing site GMP status and sterile release documentation
Validate supply continuity by reviewing whether the product is repeatedly backordered or constrained in major distribution channels

Which companies supply both atropine and pralidoxime chloride (hospital antidote bundles)?

Answer: Many suppliers distribute atropine and pralidoxime chloride separately, but hospitals often consolidate through wholesalers and group purchasing organizations rather than dual sourcing from the same manufacturer. The overlap is driven by logistics and GPO contracts more than by single-firm manufacture of both actives.

What to look for if consolidating procurement

Supplier’s finished-dose portfolios covering both parenteral atropine and parenteral pralidoxime
Ability to meet forecasted lead times for antidote stock rotation
Stability of sterile manufacturing capacity and regulatory consistency

What is the Orange Book status of atropine and pralidoxime chloride products?

Answer: Orange Book status is product- and NDC-specific. For generic injectables, exclusivity is usually limited and patents are often “older” and already expired for widely used emergency antidotes. Some products can still have formulation or method-of-use patents, but this varies by brand and strength.

Where to check

FDA Orange Book for each NDC strength and dosage form corresponding to the specific supplier’s finished product
Cross-check whether the product is listed as “Approved Drug Products with Therapeutic Equivalence Evaluations” and whether any listed patents remain active

When does the patent and exclusivity risk for atropine injectables end?

Answer: For most widely marketed atropine injectable generics, exclusivity and key patents are typically already past the active window. Risk is more likely to appear in niche strengths, specific container/closure systems, or formulation-specific product lineages.

What drives residual risk

Formulation or manufacturing-process patents
Differences in salts, pH, preservative system, or sterile filtration/terminal sterilization approach

When does the patent and exclusivity risk for pralidoxime chloride injections end?

Answer: As with atropine, pralidoxime chloride injectable exclusivity tends to be limited for legacy products. Residual risk can persist for specific finished-dose presentations and manufacturing-process IP.

What drives residual risk

Sterile formulation or presentation claims
Process and site-specific manufacturing method patents

What patent estate issues can block supply or cause scarcity for these antidotes?

Answer: IP blocking usually arises from:

formulation or process patents covering specific injectable presentation
method-of-use patents in certain indications
manufacturing-site constraints unrelated to patent scope (sterile capacity and inspection outcomes)

Where patent constraints show up in practice

Paragraph IV challenges are more relevant for brand-to-generic transitions when a still-protected NDA exists.
For older emergency antidotes, scarcity is more commonly driven by supply-chain and sterile manufacturing constraints than by active patent litigation.

How do generic entry and compounding rules affect atropine and pralidoxime chloride sourcing?

Answer: Generic entry can expand supplier options for atropine more easily than for pralidoxime chloride because the latter has narrower commercial scale. Compounding is generally used during shortages but does not replace FDA-approved product procurement for hospitals when approved sources are available.

Commercial implications

Atropine: broader generic availability tends to reduce shortage duration.
Pralidoxime: fewer approved sources increase exposure to plant shutdowns, quality events, and limited batch releases.

What formulation and manufacturing/IP barriers matter most for these injectables?

Answer: For both actives, the barriers are typically sterile manufacturing and product-specific formulation claims.

Atropine-specific barriers

Ensuring assay stability and sterility assurance across terminal sterilization or aseptic fill-finish
Container-closure compatibility (adsorption to certain plastics, particulates, and extractables)

Pralidoxime chloride-specific barriers

Stability of oxime compounds in solution form
Preservative compatibility, pH control, and avoiding degradation products
Batch consistency for sterile release at low-volume antidote scales

What FDA regulatory constraints affect supplier qualification and ongoing supply?

Answer: Supplier eligibility is constrained by current GMP compliance, sterile manufacturing inspection outcomes, and ongoing FDA product quality expectations.

Key regulatory levers

Drug product quality (sterility, endotoxin, particulates, assay)
Chemistry, manufacturing, and controls (CMC) consistency
Post-approval changes requiring reporting or supplements

Key Takeaways

Atropine injectable supply is typically broader and dominated by large sterile generic manufacturers and their finished-dose portfolios.
Pralidoxime chloride injectable supply is narrower, with higher dependence on fewer finished-dose producers and specific sterile formulation and packaging presentations.
Orange Book status and patent risk are product- and NDC-specific; for most legacy antidote injectables, active exclusivity is usually limited, while formulation/process IP and CMC-driven constraints can still affect specific presentations.
Shortage risk is more often driven by sterile manufacturing capacity, inspection events, and batch release constraints than by active patent litigation for these mature actives.

FAQs

Which NDCs should procurement teams match for atropine sulfate injection substitution?
Match by label strength, route, dosage form, and container-closure system; confirm therapeutic equivalence via Orange Book listings for the specific NDC.
Can hospitals substitute pralidoxime chloride with another oxime salt?
Substitution should follow the labeled salt form and strength; oxime salts differ in dosing equivalence and labeling.
Do atropine and pralidoxime chloride have FDA shortages listings or enforcement actions that affect availability?
Supplier availability is shaped by FDA communications on shortages and by facility-level quality issues; track the exact finished product and NDC.
Are there formulation differences that affect stability for pralidoxime chloride injections?
Yes. Oxime solution stability depends on pH, excipients, preservative systems, and sterilization approach; supplier-specific CMC determines shelf-life performance.
What is the fastest route to add an additional supplier for these antidotes?
For hospitals, procurement expansion typically follows adding approved finished-dose SKUs with validated GMP/CMC rather than relying on unapproved sources.

References (APA)

FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
FDA. Drug Shortages. https://www.accessdata.fda.gov/scripts/drugshortages/

Suppliers and packagers for generic pharmaceutical drug: atropine; pralidoxime chloride