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Suppliers and packagers for CIPROFLOXACIN HYDROCHLORIDE
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CIPROFLOXACIN HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Altaire Pharms Inc | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 204613 | ANDA | Altaire Pharmaceuticals Inc. | 59390-217-02 | 2.5 mL in 1 BOTTLE, PLASTIC (59390-217-02) | 2018-05-04 |
| Altaire Pharms Inc | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 204613 | ANDA | Altaire Pharmaceuticals Inc. | 59390-217-05 | 5 mL in 1 BOTTLE, PLASTIC (59390-217-05) | 2018-05-04 |
| Altaire Pharms Inc | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 204613 | ANDA | Altaire Pharmaceuticals Inc. | 59390-217-10 | 10 mL in 1 BOTTLE, PLASTIC (59390-217-10) | 2018-05-04 |
| Fdc Ltd | CIPROFLOXACIN HYDROCHLORIDE | ciprofloxacin hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 077568 | ANDA | A-S Medication Solutions | 50090-4217-0 | 1 BOTTLE, PLASTIC in 1 CARTON (50090-4217-0) / 5 mL in 1 BOTTLE, PLASTIC | 2018-11-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for CIPROFLOXACIN HYDROCHLORIDE
Ciprofloxacin Hydrochloride Suppliers: API Manufacturers, Contract Manufacturers, and Key Source Options
Ciprofloxacin hydrochloride is a widely sourced fluoroquinolone antibiotic, with supply concentrated in a small set of API producers and a larger tail of formulation and packaging contract manufacturing organizations (CMOs). Buyer options typically split into (1) ciprofloxacin API supply (chemical synthesis and purification), (2) ciprofloxacin HCl intermediates used for internal manufacture, and (3) finished-dose contract manufacturing for tablets and oral solutions.
Because “suppliers” can mean different layers of the value chain, the most actionable procurement view is the API producer list plus the CMO/CDMO finished-dose manufacturing universe by dosage form.
Who supplies ciprofloxacin hydrochloride API for generic and branded products?
Ciprofloxacin API supply is dominated by Asian producers and a smaller number of Western specialty chemical firms. These firms sell ciprofloxacin hydrochloride API directly to branded manufacturers and generics and also as part of broader antibiotic portfolios.
Common API supplier categories
- Global API producers selling ciprofloxacin hydrochloride under DMFs/ASMFs and supporting cGMP release.
- Intermediate makers supplying key ciprofloxacin intermediates (often with proprietary process constraints).
- Integrated antibiotic manufacturers that also produce related fluoroquinolone APIs.
Indicative global supplier footprint (API)
The following suppliers are repeatedly cited across the market for ciprofloxacin hydrochloride API supply chains and documentation ecosystems (DMF/ASMF coverage in major regulatory regions):
| Supplier | Typical role in ciprofloxacin supply chain | Regions served |
|---|---|---|
| Hetero Drugs / Hetero Labs | API and formulation supply for generics | US/EU/ROW |
| Sun Pharma | API supply chain for antibiotics | US/EU/ROW |
| Mylan / Viatris supplier ecosystem | Procurement and supply through integrated network | US/EU |
| Lupin | API and finished-dose manufacturing network for generics | US/EU/ROW |
| Cipla | API and finished-dose network for generics | US/EU/ROW |
| Accord / Teva supplier network | Generic procurement through API and CMO partners | US/EU |
| Dr. Reddy’s | API and manufacturing footprint | US/EU/ROW |
| Sandoz | Procurement and supply via API partners and in-house | EU/ROW |
| Indian and Chinese API producers (multiple) | Base API supply for global generics | US/EU/ROW |
This category list is directionally accurate for market structure, but it is not a jurisdiction-specific roster.
Which companies manufacture ciprofloxacin hydrochloride finished dosage forms (tablets, oral suspension, IV)?
Finished-dose manufacturing includes tablets, oral suspensions, and injectable products where available. CDMOs frequently support coating, film forming, taste-masking, granulation, sterile bulk handling for injectable products, and packaging.
Typical finished-dose CMOs
- Generic-focused CDMOs producing high-volume solid oral dosage forms (film-coated tablets, immediate release tablets).
- Injectables sterile manufacturing providers for ciprofloxacin IV products and sterile ophthalmic variants (where applicable).
Procurement reality
Many buyers do not buy directly from a single CDMO for all life-cycle phases. Supply often shifts by:
- ANDA approval status (for US solid oral)
- EU/National authorization requirements
- Sterile capacity and aseptic validation
- Packaging component availability (blister film, bottles, child-resistant caps)
What are the main ciprofloxacin hydrochloride supply regions (India, China, Europe, US)?
Asia as the production base
Ciprofloxacin hydrochloride API production is heavily concentrated in India and China due to scale economics in chemical synthesis, established antibiotic manufacturing clusters, and DMF/ASMF support pipelines. European and US production exists but typically plays a smaller volume role.
Europe and the US
Western supply is more commonly anchored in:
- Finished-dose manufacturing capacity and distribution
- Select API or intermediate manufacture for local regulatory and logistics resilience
- CDMO partnerships for lifecycle management
How do suppliers qualify ciprofloxacin hydrochloride API (DMF/ASMF, COA, stability, impurity control)?
Ciprofloxacin HCl buyers usually qualify suppliers via a predictable set of quality and regulatory controls.
Quality qualification elements
- Regulatory dossier coverage: DMF (US) or ASMF (EU) linkage to product applications.
- Impurity profile control: specs aligned to pharmacopeia and regulatory expectations for fluoroquinolones.
- Stability data package: accelerated and long-term storage conditions, retest periods.
- Analytical method transferability: HPLC/LC-MS suitability, reference standards.
- Batch traceability: synthetic route control and change management.
Procurement deliverables
- Full COA by batch and lot-specific impurity tables.
- GMP certificate and audit history (or reliance packages).
- Supply continuity plan (capacity and lead time in API and intermediates).
Which suppliers provide ciprofloxacin hydrochloride intermediates and custom synthesis?
Many buyers source ciprofloxacin intermediates instead of or alongside final API supply, especially where:
- They support in-house API manufacture.
- They need process continuity during capacity constraints.
- They want geographic and supplier redundancy.
Intermediate-driven procurement
Common intermediate procurement patterns include:
- Precursor chemicals for quinolone ring formation
- Chlorinated or fluorinated intermediates
- Downstream purification intermediates
Intermediate suppliers typically support multiple clients, but trade in customer-specific process improvements is controlled through NDA and quality agreements.
What generic entry risks exist if ciprofloxacin hydrochloride suppliers face capacity limits?
Supply disruptions are a commercial risk because ciprofloxacin is mature and has long-established generic competition. When API supply tightens:
- Lead times can extend rapidly.
- Prices move with spot availability.
- Lower-cost suppliers win orders but may face more frequent out-of-spec or documentation delays under audit scrutiny.
Business impact
- Shortage risk for high-usage strengths and dosage forms.
- Allocation risk during regional procurement surges.
- Line-change downtime for formulation and packaging plants if API qualification lags.
How does supplier switching affect regulatory approval for ciprofloxacin hydrochloride products?
Supplier switching often triggers regulatory workstreams:
- Comparability for API changes (process and control strategy).
- CQA re-justification for dissolution, impurity carryover, and stability.
- Variation submissions (US Changes Being Effected supplements/annual report variations, EU variations) depending on the scope.
Practical constraint
If a product is approved to a specific API source/dossier, buyers must manage:
- Cross-dossier traceability
- Impurity/spec alignment
- Stability bridging and continued compliance
Which suppliers are most credible for R&D or tech transfer of ciprofloxacin manufacturing processes?
Credible tech-transfer partners generally provide:
- Documented process controls and impurity understanding.
- Method development support and reference standard management.
- Demonstrated ability to scale while maintaining particle size and polymorph control (for solid oral downstream compatibility).
Evaluation signals
- Robust change control history
- Documented batch uniformity performance
- Audit readiness and responsiveness on deviations
Key Takeaways
- Ciprofloxacin hydrochloride supply is concentrated in a set of global fluoroquinolone API producers plus a broad set of finished-dose and sterile-capable CMOs.
- Procurement should be structured around the layer that matters: API dossier linkage for generics, and dosage form capability for finished-dose supply.
- Supplier qualification and regulatory variability management are the critical constraints for switching or dual sourcing.
- Asia dominates API production, which shapes pricing, lead times, and contingency planning for buyers.
FAQs
1) What dosage forms use ciprofloxacin hydrochloride API most frequently?
Most frequently: immediate-release tablets and other solid oral formats; injectable forms are also important where marketed in-country.
2) Are ciprofloxacin hydrochloride tablet suppliers interchangeable across all strengths?
No. Strength-specific formulation, dissolution targets, and stability lots can create qualification differences even when API is the same.
3) Can buyers source ciprofloxacin hydrochloride from both India and China to reduce risk?
Yes, dual sourcing is common for continuity, but it requires rigorous impurity/spec alignment and regulatory variation management.
4) What documentation is typically required when qualifying a new ciprofloxacin hydrochloride supplier?
DMF/ASMF linkage, GMP certificate, method summaries, COAs with impurity breakdown, and stability documentation are typical baseline requirements.
5) How do aseptic/sterile constraints affect ciprofloxacin IV supplier selection?
Injectable procurement depends on sterile facility capability, aseptic validation, batch release systems, and availability of sterile packaging components, which can differ from solid oral supply chains.
References
- U.S. Food and Drug Administration. (n.d.). Drug master files (DMFs). https://www.accessdata.fda.gov/scripts/cder/dmf/
- European Medicines Agency. (n.d.). Active substance master files (ASMF). https://www.ema.europa.eu/en/human-regulatory/research/advanced-therapies/active-substance-master-files
- United States Pharmacopeia. (n.d.). USP monographs and specifications for ciprofloxacin and related substances. https://www.uspnf.com/
- World Health Organization. (n.d.). WHO guidelines and documentation on pharmaceutical quality assurance and GMP expectations. https://www.who.int/teams/regulation-prequalification/pharmaceuticals/quality-assurance
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