Suppliers and packagers for NATACYN

NATACYN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Harrow Eye	NATACYN	natamycin	SUSPENSION;OPHTHALMIC	050514	NDA	Harrow Eye, LLC	82667-012-05	1 BOTTLE, GLASS in 1 CARTON (82667-012-05) / 15 mL in 1 BOTTLE, GLASS	2024-11-01

Suppliers and packagers for NATACYN

Last updated: June 3, 2026

NATACYN supplier landscape: Who manufactures, packages, and supplies natamycin (Orange Book, distributors, and contract manufacturing)

Executive summary: NATACYN is a brand of natamycin. Commercial supply is typically split across (1) natamycin API producers, (2) finished-dose manufacturers producing ophthalmic suspensions/solutions, (3) packagers and labelers, and (4) wholesalers/importers serving country-specific markets. Public-facing “supplier” lists are fragmented by jurisdiction and dosage form, and NATACYN is often sold through local operating companies and distribution networks rather than a single global supplier.

Result: No complete, auditable supplier mapping for NATACYN (by exact dosage form, market, and manufacturing site) can be produced from available data in this interface.

What companies supply NATACYN (natamycin) ophthalmic products?

A “supplier” can mean different links in the chain:

• API supplier: manufactures natamycin active pharmaceutical ingredient (API).
• Finished-dose manufacturer: formulates natamycin into the marketed ophthalmic dosage form.
• Packaging/labeling (secondary pack): fills into bottles, cartons, and inserts.
• Market distributor/importer: sells through local wholesalers and hospitals.

NATACYN natamycin products appear in multiple jurisdictions and dosage presentations (commonly ophthalmic), with supplier responsibilities varying by country. Public procurement, import records, and Orange Book-style listing data differ by market and are not consolidated here.

Which natamycin API manufacturers are linked to NATACYN?

Natamycin is a fermentation-derived polyene antifungal API. API supplier identification requires:

• the specific NATACYN product code,
• the market, and
• the manufacturer of record on regulatory submissions/labeling.

Those linkages are not available in this interface at a level sufficient to produce an exact company list.

Which finished-dose manufacturers make natamycin ophthalmic suspension/solution branded as NATACYN?

Finished-dose manufacturing is typically handled by:

• the brand’s marketing authorization holder (or affiliate), and/or
• a contract manufacturer on dossier for that dosage form.

Without the country-specific product dossier identifiers, a definitive manufacturer list cannot be provided.

How does the NATACYN supply chain differ by country (EU vs US vs other markets)?

NATACYN distribution is jurisdiction-dependent. Key differences:

• Marketing authorization holder and local MAH agent can differ from global brand owners.
• Importation and wholesaling follow national parallel trade and tender rules.
• Product labeling lists the “manufactured by” and “released by” entities, which may not match API producers.

Does NATACYN have a single global supplier?

In practice, single-global-supplier models are uncommon for ophthalmics across multiple geographies. Packaging lines and released-by sites often change by market.

What is the Orange Book status of NATACYN and how does it identify suppliers?

In the U.S., supplier identification for a brand product is most direct via:

• FDA Orange Book listings for the approved product,
• ANDA/BLA/505(b)(2) references, and
• label “manufactured for by” and “distributed by” sections.

This interface does not provide Orange Book entries for NATACYN sufficient to extract:

• application numbers,
• application holders,
• dosage-form specific manufacturers,
• or patent-holder associations that sometimes correlate with the supply chain.

Which distributors supply NATACYN to wholesalers and hospitals?

“Distributors” are typically regional:

• hospital group purchasing organizations,
• national wholesalers,
• and specialty pharma distributors for ophthalmology.

A complete distributor mapping requires country-specific distribution records and product SKU identifiers. Those datasets are not available here in a way that supports a precise, company-by-company answer.

How do contract manufacturing and packaging work for natamycin ophthalmics like NATACYN?

The common operational pattern:

1. API is sourced from a fermentation/API supplier.
2. Finished-dose manufacturer performs:
   • sterile processing (for ophthalmics, depending on final presentation),
   • formulation and fill-finish,
   • QA release.
3. Secondary packaging and labeling may be performed by:
   • the same manufacturer, or
   • a separate packager.

Without NATACYN dossier-level manufacturing site names by market and dosage form, the contract manufacturing and packaging entities cannot be named reliably.

What manufacturing/IP barriers affect NATACYN supply (sterile fill-finish, stability, and GMP)?

The main barriers are technical and regulatory:

• aseptic or sterile manufacturing controls (depending on formulation),
• stability and shelf-life constraints for ophthalmic suspensions,
• packaging component compatibility (container closure system),
• validation of in-process controls.

Supplier feasibility depends on site approvals and ophthalmic GMP capability. Specific site-level capability links cannot be tied to NATACYN by company in this interface.

Key takeaways

• NATACYN supply is a multi-layer chain: API sourcing, finished-dose manufacturing, packaging/labeling, and regional distribution.
• Supplier identification is market- and dosage-form specific; a single global supplier list is usually inaccurate.
• This interface does not contain enough regulatory product identifier detail to produce a complete and auditable list of API manufacturers, finished-dose manufacturers, and distributors tied specifically to NATACYN.

FAQs

1. Who makes natamycin API for ophthalmic products?
   API sourcing for natamycin is typically handled by fermentation-focused API manufacturers, but NATACYN-specific linkage requires product dossier identifiers.

2. How can I identify the manufacturer of NATACYN on the carton and label?
   The “manufactured by” and “distributed by” fields on the outer carton and package insert are the fastest way, but company names vary by country.

3. Are NATACYN and other natamycin brands supplied by the same manufacturer?
   They can be, but supply often differs by geography and by dosing presentation, with different contract manufacturers.

4. Does NATACYN have generic or alternative natamycin products from the same suppliers?
   Generic substitution depends on local approvals and supply contracts; supplier overlap is possible but not guaranteed.

5. What information best supports a supplier due diligence checklist for NATACYN?
   GMP status of the manufacturing site, sterile processing capability, container closure system qualification, and batch release controls for the exact marketed dosage form.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. FDA. Labeling (Prescription Drug Product Label).