Suppliers and packagers for ocuflox

ocuflox

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Allergan	OCUFLOX	ofloxacin	SOLUTION/DROPS;OPHTHALMIC	019921	NDA	Allergan, Inc.	11980-779-05	1 BOTTLE, DROPPER in 1 CARTON (11980-779-05) / 5 mL in 1 BOTTLE, DROPPER	1993-08-01

Ocuflox Suppliers: Who Manufactures and Where Supply Can Be Sourced

Last updated: April 24, 2026

What company makes Ocuflox (ofloxacin ophthalmic)?

Ocuflox is an ofloxacin ophthalmic brand. Production and commercialization are split by market and regulatory pathway, and the supplier landscape depends on the country of dispensing and the registered marketing authorization.

Which suppliers dominate Ocuflox supply chains by regulatory status?

1) Branded manufacturer / marketing authorization holder (MAH)

The Ocuflox brand is marketed in multiple countries under local registrations. The MAH (and the listed manufacturer on the product label) is the primary supplier for legal distribution in each market.

Supplier identifiers to use for sourcing

• Marketing authorization holder (MAH) name on the local box label and package insert
• Manufacturer name and manufacturing site listed under “manufactured by” on the package
• Product registration number for each country (used to match to the correct manufacturer and batch release chain)

2) Contract manufacturers (if MAH outsources production)

Where the MAH does not run its own ocular-sterile line, Ocuflox is commonly produced through outsourced sterile manufacturing. In that case, “supplier” means:

• the contract manufacturer site on the label (primary sterile filling and finishing)
• the MAH supplying finished packs (secondary supply for local distribution)

3) Parallel distribution and wholesalers

In many markets, supply includes:

• licensed wholesalers importing finished packs from the MAH market
• parallel distributors sourcing from countries where the product is authorized and freely marketable

These supply channels change materially by import rules and patent or exclusivity status in-country.

How to identify the exact Ocuflox supplier for procurement (fast)

For procurement-grade verification, match Ocuflox packaging to the manufacturer-of-record in that jurisdiction. Use these supplier-trace artifacts:

Label and regulatory checks

• “Manufactured by” (company name)
• “Manufactured at” (site address)
• Batch/lot number format and shelf-life stamp
• Local registration number printed on the carton
• Distributor/marketing company printed on the carton (separate from the manufacturer)

Document checks for R&D and investment diligence

• Certificate of Analysis (CoA) batch-specific
• Stability protocol alignment with the local registration
• GMP site attestation for the manufacturing address shown on-pack

Supply chain map: what to expect from major sterile ocular suppliers

Ocuflox is an ophthalmic sterile formulation, so qualified suppliers usually include:

• sterile manufacturing and aseptic filling lines (eye-drop presentation)
• packaging line capable of preserving sterility and container integrity
• quality systems covering microbial limits, sterility assurance, and container-closure integrity

Procurement due diligence should verify:

• sterile manufacture capability (aseptic or terminal sterilization method as applicable)
• fill volume control and headspace controls
• container-closure compatibility for ofloxacin in the specified vehicle

Key sourcing constraints specific to ophthalmic antibiotics

Ocuflox supply can tighten due to:

• sterile capacity constraints at the contract manufacturer
• regulatory scrutiny around aseptic manufacturing
• import restrictions or labeling requirements by destination country

Key Takeaways

• Ocuflox suppliers are jurisdiction-specific: the “manufacturer on-pack” and the “MAH on local registration” determine the true legal supplier for that market.
• Procurement-grade sourcing requires label-based matching to the manufacturing site and batch CoA alignment.
• For ocular sterile products, supply bottlenecks typically trace back to aseptic sterile manufacturing capacity and regulatory approvals for the exact manufacturing site shown on-pack.

FAQs

1) Are Ocuflox suppliers the same across all countries?

No. The MAH and manufacturer of record can differ by market and regulatory registration.

2) How do I confirm the real Ocuflox manufacturer for a specific lot?

Use the “manufactured by / manufactured at” fields on the box and confirm with the batch-specific CoA.

3) Can wholesaler “suppliers” be substituted for the MAH manufacturer?

Wholesalers supply distribution, not manufacture. For procurement and quality assurance, the manufacturing site on-pack drives qualification.

4) What typically controls supply availability for Ocuflox?

Aseptic/sterile manufacturing line availability, regulatory status of the manufacturing site, and import approvals in the destination market.

5) What documents matter most when qualifying Ocuflox suppliers?

Batch-specific CoA, product labeling/regulatory number match, and GMP site evidence tied to the manufacturing address on the carton.

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References

1. FDA. Labeling and package insert requirements for ophthalmic drug products. U.S. Food and Drug Administration. https://www.fda.gov/