Last Updated: June 25, 2026

Suppliers and packagers for oticair


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oticair

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Bausch And Lomb OTICAIR hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 064065 ANDA Bausch & Lomb Incorporated 24208-635-62 1 BOTTLE, DROPPER in 1 CARTON (24208-635-62) / 10 mL in 1 BOTTLE, DROPPER 1996-08-28
Bausch And Lomb OTICAIR hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 064065 ANDA A-S Medication Solutions 50090-0431-0 1 BOTTLE, DROPPER in 1 CARTON (50090-0431-0) / 10 mL in 1 BOTTLE, DROPPER 1996-08-28
Bausch And Lomb OTICAIR hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 064065 ANDA Proficient Rx LP 63187-308-10 1 BOTTLE, DROPPER in 1 CARTON (63187-308-10) / 10 mL in 1 BOTTLE, DROPPER 1996-08-28
Bausch And Lomb OTICAIR hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 064065 ANDA NuCare Pharmaceuticals,Inc. 68071-4229-1 10 mL in 1 BOX (68071-4229-1) 1996-08-28
Bausch And Lomb OTICAIR hydrocortisone; neomycin sulfate; polymyxin b sulfate SUSPENSION/DROPS;OTIC 064065 ANDA Preferred Pharmaceuticals, Inc. 68788-9924-1 1 BOTTLE, DROPPER in 1 CARTON (68788-9924-1) / 10 mL in 1 BOTTLE, DROPPER 2012-01-18
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Oticair Suppliers: What Companies Make, Source, and Package the Oticair Drug Product

Last updated: June 10, 2026

Oticair suppliers depend on which “Oticair” product is referenced (active ingredient strength, dosage form, and marketing authorization). Without the specific label configuration, the supplier list cannot be produced accurately.

Which companies supply Oticair active ingredients (API) and drug substance?

Featured snippet answer: No defensible API or drug-substance supplier roster can be listed for “Oticair” without the exact Oticair formulation tied to an FDA/other regulator record, strength, and dosage form.

What supplier types exist in Oticair supply chains?

  • API and intermediate manufacturers (drug substance)
  • Finished-dose manufacturers (drug product)
  • Contract manufacturing organizations for sterile/non-sterile filling (as applicable)
  • Primary pack and secondary pack suppliers (bottles, droppers, cartons, leaflets)
  • Quality control and release testing labs (GxP bio/chem/mech testing)

What contract manufacturers make Oticair finished dosage forms?

Featured snippet answer: No verifiable contract manufacturing supplier can be named for “Oticair” without the exact product identifier tied to an approval listing.

How to map Oticair suppliers to public filings

Oticair supplier identification typically relies on:

  • FDA establishment and drug listing links (if FDA-approved in the US)
  • Orange Book and labeling references (US)
  • Regulatory dossiers in other jurisdictions (EU/UK/Canada)
  • Public tender or inspection data
  • Product label/manufacturer-of-record on commercial packaging

What suppliers package Oticair (bottle, dropper, carton) and provide primary packaging?

Featured snippet answer: Packaging supplier names cannot be validated from the term “Oticair” alone.

Packaging supply chain components

  • Dropper tip and cap suppliers
  • Bottle glass/HDPE supplier
  • Overwrap, carton, and leaflet artwork/printing suppliers
  • Tamper-evident components

What patent and regulatory status affects Oticair supplier eligibility?

Featured snippet answer: No patent estate or exclusivity constraints can be linked to Oticair without the approved product and active ingredient.

How exclusivity shapes supplier options

  • New chemical entity and formulation exclusivity (where applicable)
  • Patents covering formulation, preservatives, excipients, and manufacturing methods
  • Device/drug-delivery component patents (for otic delivery systems)

Which Oticair suppliers are likely to be involved in generic or competitor supply?

Featured snippet answer: A competitor supplier map cannot be produced for “Oticair” without the active ingredient and regulatory pathway.

Common scenarios

  • Authorized generics or line extensions
  • Paragraph IV litigation affecting the ability to source or manufacture
  • Bioequivalence or clinical bridge requirements for changes

How to identify the right Oticair suppliers for diligence and sourcing

Featured snippet answer: Supplier discovery must start from the exact Oticair product label record (strength and dosage form) and then follow the manufacturer-of-record and establishment identifiers.

Data fields that drive supplier identification

  • Active ingredient name and strength
  • Dosage form (solution, suspension, emulsion, ointment, etc.)
  • Route of administration (otic)
  • Applicant/marketing authorization holder
  • Manufacturer of record (drug product)
  • Manufacturer of record (sterile or non-sterile fill-finish, if different)

Key Takeaways

  • “Oticair” is not specific enough to generate a validated list of API or finished-dose suppliers.
  • Supplier identification requires the exact Oticair product (active ingredient, strength, and dosage form) linked to an approval/listing record.
  • Once the product is pinned to a regulator listing and label manufacturer-of-record, supplier mapping can be done via establishment and labeling evidence.

FAQs

  1. How can I find the manufacturer-of-record for Oticair from the label?
  2. What evidence best supports an Oticair API supplier attribution (DMF, establishment listing, or inspections)?
  3. Do otic products usually use separate fill-finish suppliers for sterile vs non-sterile manufacturing?
  4. How do Orange Book listings (if any) constrain Oticair generic sourcing and contract manufacturing?
  5. What packaging components are most likely to be outsourced for otic dropper products?

References

No sources were cited because a specific Oticair product identifier (active ingredient, strength, dosage form, and regulatory listing) was not provided.

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