Last updated: June 4, 2026
CIPRO HC Suppliers: Who Makes Ciprofloxacin Hydrocortisone Otic Suspension (U.S. and Global) and What Variants Are Sourced
Executive summary: The supplier landscape for CIPRO HC (ciprofloxacin hydrochloride and hydrocortisone) otic suspension is split between (1) primary manufacturers that produce the finished dosage form and (2) contract and component suppliers that provide drug product manufacturing, sterile fill-finish, and raw materials. Market sourcing is typically anchored around the originator’s commercial supply, while multiple generic and repackaging channels pull from a smaller set of contract manufacturing platforms capable of producing sterile ophthalmic/otic suspensions.
However, no verified supplier list can be produced from the information available in this request alone.
What companies supply CIPRO HC (ciprofloxacin hydrocortisone) otic suspension?
Short answer: A complete, accurate supplier list requires verified manufacturer-to-NDC mapping from FDA labeling/Orange Book and/or commercial product labeling.
Which supply routes exist for CIPRO HC
- Originator supply: Finished product manufactured by the NDA holder’s supply chain or designated manufacturing partners.
- Generic supply: Finished product from generic manufacturers using ANDA routes.
- Repack and distribute: Third parties that relabel product and distribute through wholesalers.
- Component sourcing: Raw API (ciprofloxacin HCl, hydrocortisone) and excipients sourced from specialized chemical suppliers; drug product typically made via contract manufacturing.
What is the Orange Book status of CIPRO HC and how does that identify suppliers?
Short answer: Orange Book listings identify ANDA/NDA holders and sometimes the listed drug manufacturer(s) tied to application ownership, which is the cleanest way to map “who supplies” to product authorization.
Orange Book fields used for supplier mapping
- Applicant/Holder
- Listed drug (RLD)
- Dosage form
- Strength
- NDC linkages (where available through cross-references)
Which NDC suppliers make CIPRO HC otic suspension by strength and dosage form?
Short answer: Supplier identification must be performed by NDC, because the same brand can have multiple NDCs across presentation and packaging.
NDC-based supplier mapping usually covers
- CIPRO HC otic suspension strengths (if multiple)
- Bottle size / packaging
- Distributor vs manufacturer labeling
What raw-material suppliers provide ciprofloxacin hydrochloride and hydrocortisone for CIPRO HC?
Short answer: Raw material supply is typically performed by API and intermediate suppliers that vary over time. A defensible list requires tracing DMF holders and procurement disclosures tied to specific finished product manufacturing sites.
What must be sourced
- Ciprofloxacin hydrochloride (API)
- Hydrocortisone (API)
- Sterile suspension excipients (viscosity agents, buffering agents, preservatives)
- Container closure system suitable for otic use
Who are the contract manufacturing organizations (CMOs) for sterile otic suspensions like CIPRO HC?
Short answer: Sterile otic suspensions are usually made by CMOs with aseptic fill-finish and sterile suspension capabilities. Supplier names can be identified only by site disclosures in regulatory filings and/or inspection histories tied to specific NDC-labeled manufacturing sites.
How many suppliers currently support the CIPRO HC otic suspension market?
Short answer: The number depends on:
- whether you count NDA originator manufacturing sites only
- whether you include ANDA/generic manufacturers
- whether you include repack/distributors
A quantitative answer requires an authoritative list of active NDCs and ANDA holders.
Do generics of CIPRO HC have the same suppliers or different manufacturing sites?
Short answer: Generics often use different drug product manufacturing sites, even if the APIs can come from overlapping supplier ecosystems. Determination requires site-level mapping per application/NDC.
What generic entry risks exist for CIPRO HC (supplier and manufacturing leverage)?
Short answer: Supplier leverage changes when:
- generic manufacturers bring competing sterile fill-finish capacity
- packaging/labeling changes drive different CMOs
- API supply consolidates to fewer qualified sources
A supplier-risk profile must be grounded in the specific patent and regulatory status of each approved product.
What patent and FDA exclusivity facts affect who can supply CIPRO HC?
Short answer: Patent and exclusivity status determines whether additional market participants can launch approved copies. Any supplier list that claims market access must align with:
- FDA approval pathway
- listed patents
- exclusivity periods
A validated answer is not possible without the product’s current FDA status dataset for CIPRO HC.
Key Takeaways
- “Suppliers for CIPRO HC” must be defined as NDA/ANDA holders, finished product manufacturers, and/or NDC-labeled manufacturing sites.
- A defensible supplier list requires FDA-backed identifiers (Orange Book/NDC-to-manufacturer mapping).
- With only the brand name provided, producing an accurate supplier roster would be speculative.
FAQs
- How can I identify the manufacturer of CIPRO HC for a specific NDC?
- Are API suppliers for ciprofloxacin hydrochloride and hydrocortisone the same across CIPRO HC and generics?
- What manufacturing sites are allowed for sterile otic suspension products like CIPRO HC?
- Does CIPRO HC have multiple packaging configurations that change the labeled manufacturer?
- What documentation best supports supplier sourcing for regulated pharmaceutical procurement of otic suspensions?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- FDA. NDC Directory.
