Suppliers and packagers for ATROPINE (AUTOINJECTOR)

ATROPINE (AUTOINJECTOR)

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Rafa Labs Ltd	ATROPINE (AUTOINJECTOR)	atropine	SOLUTION;INTRAMUSCULAR	212319	NDA	Rafa Laboratories, Ltd.	71053-592-01	480 CARTON in 1 BOX (71053-592-01) / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGE	2018-07-09

Atropine (Autoinjector) Suppliers: Who Makes It, Who Supplies Components, and What Matters for Availability

Last updated: June 4, 2026

Atropine autoinjectors are supplied through a narrow set of qualified manufacturers for the finished device and through specialized suppliers for autoinjector platforms, needle/spring systems, sterilization, and packaging. However, a complete, verifiable “supplier list” with firm names tied to specific marketed presentations (e.g., 0.5 mg/mL vs 2 mg, single-dose vs twin-pack kits, and specific NDCs) cannot be produced from the information provided.

Who are the autoinjector suppliers for atropine?

Featured answer: Autoinjector platforms and components for atropine products are typically sourced from established medical device OEMs (autoinjector and needle/spring systems), while the drug product is manufactured by pharmaceutical firms with FDA device combination product capability.

Which companies commonly supply autoinjector platforms used in drug delivery

Autoinjector platform supply is usually handled by:

• Autoinjector device OEMs that provide a complete “mechanism + housing” system
• Needle and cannula suppliers (including laser machining and staked assemblies)
• Spring, actuator, and trigger suppliers
• Sterility assurance and terminal sterilization partners
• Sterile barrier packaging and secondary kit packaging suppliers

What suppliers must be qualified for an atropine autoinjector

For an FDA-regulated atropine autoinjector (combination device product), suppliers must typically support:

• Device component traceability (lot-level genealogy)
• Sterility assurance for needle and drug-contacting parts
• Function testing under device operating windows (force, stroke, injection time)
• Human factors validation deliverables for labeling-consistent actuation
• Cold-chain or temperature excursion constraints if required for the drug formulation

What parts supply chain exists for an atropine autoinjector (mechanism, needle, container)?

Featured answer: The supply chain breaks into four technical layers: (1) needle/cannula assembly, (2) mechanism and energy storage, (3) drug container and sterile wetted parts, (4) packaging and kit assembly.

Needle and cannula assembly suppliers

Key requirements:

• Precision needle geometry to hit injection depth and flow profile
• Needle shielding and safety interlock reliability
• Surface treatment and biocompatibility documentation
• Sterilization compatibility (EO gas, radiation, or other validated method)

Spring, actuator, and trigger mechanism suppliers

Key requirements:

• Consistent force delivery across shelf life
• Tolerances on trigger friction and latch engagement
• Corrosion resistance and mechanical fatigue qualification
• Compliance with medical device material and extractables/leachables expectations

Drug container and sterile wetted part suppliers

Key requirements:

• Syringe barrel and plunger compatibility with atropine formulation
• Container closure integrity for single-dose systems
• Assembly line control that supports cGMP and device-mandated inspections

Sterile and secondary packaging suppliers

Key requirements:

• Tray/liner design for device stability during shipping and handling
• Tamper evidence and kit configuration control
• Insert and labeling production support for FDA-compliant cartons

Which pharmaceutical manufacturers make atropine autoinjector drug product?

Featured answer: Atropine autoinjector drug product is manufactured by pharmaceutical firms that hold NDA/BLA-level responsibility for drug substance and drug product and can support combination product manufacturing controls. A product-specific manufacturer list requires the exact marketed atropine autoinjector presentation and NDC.

What matters for identifying the correct drug product manufacturer

Supplier mapping must be anchored to:

• Specific NDC and strength
• Holder of FDA approval for the combination product
• Manufacturing site listed in FDA submissions and labeling
• Distribution channel (federal contract vs commercial)

Which contract manufacturing organizations (CMOs) support atropine autoinjectors?

Featured answer: CMOs typically support formulation filling, terminal sterilization processes, device assembly, and kit packaging. The CMO identity is presentation-specific and tied to the approved manufacturing sites and labeling.

Where CMOs usually plug into the autoinjector value chain

• Drug filling into pre-assembled syringes or cartridges
• Sterile fill-finish
• Device assembly integration under controlled inspection plans
• Final packaging and distribution readiness testing

How can you verify atropine autoinjector suppliers from FDA and labeling records?

Featured answer: Supplier verification is done through FDA labeling, Orange Book/device combination product references, and inspection-facing manufacturing site disclosures.

Source pathways used in due diligence

• FDA product labeling (drug label and device insert)
• NDC directory and product listing
• FDA records for combination product classification and manufacturing responsibilities
• Establishment inspection and registration (where public)
• Publicly available FDA correspondence for manufacturing site changes

What generic or biosimilar entry risks exist for atropine autoinjectors?

Featured answer: Atropine autoinjector “generic” risk depends on whether the marketed product is an FDA-approved drug-device combination with narrow IP and whether an ANDA can replicate the device performance and sterile system.

What drives time-to-entry

• Ability to match device performance parameters under bioequivalence-relevant criteria
• Compatibility of sterile wetted parts and container closure
• Device design constraints that affect injection flow and administration time
• CMC readiness for fill-finish and device integration

What patent and exclusivity considerations affect supplier switching for atropine autoinjectors?

Featured answer: Supplier switching is constrained when the autoinjector formulation, device mechanism, or method-of-use is protected by patents that extend to the specific strength, configuration, and delivery profile.

How exclusivity maps to supply chain selection

• Device patents can block “workalike” autoinjector mechanism replication
• Formulation or fill-finish process patents can block contract filling
• Method-of-use patents can constrain labeling changes
• Combination product patent families can increase barriers to generic device replication

How does atropine autoinjector supply compare across regions and contracts?

Featured answer: Supply can differ materially between commercial distribution and government or emergency-response contracts, changing which qualified manufacturers are in the supply chain at any point in time.

What changes supplier rosters

• Batch release capacity limits
• Procurement specifications that require particular device features
• Local regulatory and labeling requirements
• Contractual qualification and audit cycles

Key Takeaways

• Atropine autoinjector supply chains split across device OEMs (mechanism and needle systems) and pharmaceutical firms (drug product manufacturing and combination product responsibility).
• A reliable “supplier list” must be tied to a specific marketed presentation (NDC, strength, packaging configuration) to identify the finished-product manufacturer and the device platform contributor.
• Supplier switching is constrained by device performance replication requirements and by potential patent coverage spanning device mechanism and sterile system integration.
• Due diligence should use FDA labeling and registration artifacts anchored to the exact NDC to map the true responsible manufacturers and approved sites.

FAQs

1. How do I identify the autoinjector OEM used for a specific atropine autoinjector NDC?
2. What device performance criteria are typically required for an atropine autoinjector to be considered equivalent?
3. Do atropine autoinjectors qualify as FDA drug-device combination products, and how does that affect supplier selection?
4. What CMC steps are most likely to be contract-manufacturing bottlenecks for autoinjector products?
5. How do patent estates covering needle or actuation mechanisms impact autoinjector generic device development?

References (APA)

1. FDA. (n.d.). Orange Book and FDA drug product databases. U.S. Food and Drug Administration.
2. FDA. (n.d.). Drug-device combination product information and product-specific labeling resources. U.S. Food and Drug Administration.
3. FDA. (n.d.). NDC Directory and labeling records. U.S. Food and Drug Administration.