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Suppliers and packagers for CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE
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CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cosette Pharms Nc | CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE | ciprofloxacin hydrochloride; hydrocortisone | SUSPENSION/DROPS;OTIC | 218273 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0851-09 | 1 BOTTLE in 1 CARTON (0713-0851-09) / 10 mL in 1 BOTTLE | 2025-12-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Ciprofloxacin Hydrochloride and Hydrocortisone (API and Key Starting Materials)
Which suppliers manufacture ciprofloxacin hydrochloride and hydrocortisone?
Ciprofloxacin hydrochloride and hydrocortisone are typically supplied through three channels: (1) API manufacturers, (2) intermediate/starting-material suppliers, and (3) custom synthesis/contract manufacturers. The supplier set depends on whether you need full API, an intermediate, or a finished combination product feedstock.
Ciprofloxacin hydrochloride (API) supplier categories used in industry
| Supplier type | What they provide | Common procurement route |
|---|---|---|
| API manufacturer | Ciprofloxacin hydrochloride (typically polymorph/grade-specific) | Direct API purchase or distributor |
| Intermediate manufacturer | Ciprofloxacin synthesis intermediates | Contracting for multi-step supply chains |
| CMOs with API capability | API manufacture under cGMP/DMF-ready supply | Commercial scale runs under quality agreements |
Hydrocortisone (API) supplier categories used in industry
| Supplier type | What they provide | Common procurement route |
|---|---|---|
| API manufacturer | Hydrocortisone USP/EP grade (or marked equivalent) | Direct API purchase or distributor |
| Intermediate manufacturer | Hydrocortisone-related steroids or precursors | Multi-lot supply to secure continuity |
| CMOs with steroid capability | API manufacture under cGMP | Scale-up and batch release under agreements |
Which suppliers should procurement teams verify first for compliance and supply continuity?
For both APIs, procurement teams typically prioritize suppliers that can support one or more of the following: regulatory dossier readiness (for example DMF or CEP), consistent assay and impurity profiles, and documented batch traceability.
Procurement verification checklist (practical)
| Verification item | Why it matters | How it maps to supplier selection |
|---|---|---|
| Regulatory dossier status (DMF/CEP) | Lowers approval friction | Prefer suppliers with active filings |
| GMP footprint and inspection history | Reduces supply and regulatory risk | Prefer suppliers with clean cGMP track records |
| Analytical package (CoA plus impurity methods) | Ensures batch-to-batch consistency | Require complete spec and method references |
| Supply capacity and lead times | Avoids shortages | Use published capacity where available |
| Change control and stability commitments | Limits post-change compliance risk | Confirm lifecycle controls |
How do suppliers differ across ciprofloxacin hydrochloride vs hydrocortisone?
Ciprofloxacin hydrochloride
- Production is built around chirality-controlled fluoroquinolone chemistry and impurity control (process-related degradants and stereochemical impurities).
- Supplier differentiation tends to come from impurity clearance, scale yields, and consistency across synthetic routes.
Hydrocortisone
- Production is steroid chemistry with tighter controls on stereochemistry, oxidation state, and related substances.
- Supplier differentiation tends to come from steroid intermediate sourcing reliability and impurity profile control.
Typical supplier landscape (global) for these two APIs
Below is the supplier landscape procurement teams usually see in practice. Names appear here only when supported by documented public regulatory or manufacturing references in sourced materials.
Global API manufacturer landscape used for ciprofloxacin hydrochloride
| Region | Supplier roles commonly present | What to target in sourcing |
|---|---|---|
| India | Multiple API manufacturers | DMF/CoA consistency, multi-grade availability |
| China | Large-scale API capacity | Impurity control and batch documentation |
| Europe/US | Smaller number of API producers | Dossier readiness and audit history |
Global API manufacturer landscape used for hydrocortisone
| Region | Supplier roles commonly present | What to target in sourcing |
|---|---|---|
| India | Steroid API suppliers and intermediates | Impurity specs and consistent steroid starting feed |
| China | Steroid API and intermediate scale | Robust analytical packages and impurity method access |
| Europe/US | Specialty steroid producers | GMP documentation depth and stability data |
What about suppliers for combination products containing both?
If the objective is a combination product (for example, a formulation that contains ciprofloxacin and hydrocortisone together for topical/otologic/ophthalmic use), the supply chain often looks like this:
- API suppliers deliver ciprofloxacin hydrochloride and hydrocortisone separately.
- A formulation manufacturer (CMO) builds the finished dose form under GMP.
- Release specifications and stability programs are handled at the finished product stage.
This means “supplier” could mean either API manufacture or formulation manufacturing, depending on the business need.
Which suppliers can provide finished dosage or contract manufacturing (CMO) for ciprofloxacin/hydrocortisone combinations?
In practice, CMOs that handle ophthalmic/otic/topical formulations with steroid and antibiotic combinations are typically used. Supplier identification in this area depends on the exact dosage form (e.g., ophthalmic suspension, otic drops, topical cream/ointment). Without dosage-form specificity, the only defensible path is API sourcing first, then a compatible formulation CMO.
Key sourcing outcomes procurement should insist on (to reduce failed audits and rejected batches)
| Outcome | Required supplier proof | Contract clause direction |
|---|---|---|
| Batch traceability | Lot genealogy and raw material trace records | Require documentation package per lot |
| Spec and method alignment | CoA includes all test parameters and validated methods | Reference method acceptance limits |
| Impurity and degradant control | Defined thresholds plus trending data | Require change control on routes/reagents |
| Supply continuity | Confirm capacity and safety stock | Include lead time SLAs and contingency options |
Key Takeaways
- Ciprofloxacin hydrochloride and hydrocortisone are sourced through API manufacturers and, for formulation needs, via CMOs that build antibiotic-steroid combination dosage forms.
- Supplier selection hinges on regulatory dossier readiness (DMF/CEP where applicable), analytical package completeness, impurity control, and cGMP audit history.
- For combination products, procurement typically buys both APIs separately and qualifies a formulation CMO if the finished-dose route is required.
FAQs
-
Do ciprofloxacin hydrochloride and hydrocortisone suppliers overlap?
Some suppliers operate across multiple API classes, but overlap is not guaranteed; it is common to source each API from different manufacturers. -
What documentation should be non-negotiable for both APIs?
Lot-specific CoAs aligned to defined impurity thresholds, full analytical method references, and batch traceability. -
How do impurity profiles drive supplier selection for ciprofloxacin hydrochloride?
Process-related impurities and stereochemical or degradant control determine acceptance and stability performance. -
How do steroid impurities drive supplier selection for hydrocortisone?
Related substances and steroid-specific impurities must match tight pharmacopeial or internal limits. -
If the end goal is a ciprofloxacin/hydrocortisone product, what changes in sourcing?
The scope expands from API qualification to formulation CMO qualification, including stability and container closure requirements at the finished-dose level.
References (APA)
[1] U.S. Food and Drug Administration. (n.d.). Drug approval reports and related resources. https://www.fda.gov/
[2] European Medicines Agency. (n.d.). European public assessment reports (EPARs) and related resources. https://www.ema.europa.eu/
[3] World Health Organization. (n.d.). WHO guidelines and relevant pharmacopeial references. https://www.who.int/
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