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Suppliers and packagers for GENTAK
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GENTAK
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Pharmobedient | GENTAK | gentamicin sulfate | SOLUTION/DROPS;OPHTHALMIC | 064163 | ANDA | Proficient Rx LP | 63187-764-05 | 1 BOTTLE, DROPPER in 1 CARTON (63187-764-05) / 5 mL in 1 BOTTLE, DROPPER | 2006-12-13 |
| Pharmobedient | GENTAK | gentamicin sulfate | SOLUTION/DROPS;OPHTHALMIC | 064163 | ANDA | NuCare Pharmaceuticals, Inc. | 66267-971-05 | 1 BOTTLE, DROPPER in 1 CARTON (66267-971-05) / 5 mL in 1 BOTTLE, DROPPER | 2006-12-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for GENTAK
GENTAK (gentamicin) Suppliers: Who Manufactures and Supplies the Product, APIs, and Generic Alternatives
Executive summary: GENTAK is a brand of gentamicin for ophthalmic use. The supplier landscape depends on whether you mean (1) the branded product, (2) generic ophthalmic gentamicin products, or (3) the underlying gentamicin drug substance (API). Without a specified dosage form/strength (e.g., ophthalmic ointment vs solution), supplier coverage cannot be stated completely and accurately.
Who supplies GENTAK brand gentamicin ophthalmic products in the US?
Answer (status-by-status): A complete supplier list for the GENTAK brand requires matching the exact FDA product listing (labeler, dosage form, strength) to identify the current marketing authorization holder and contract manufacturers. Product-level supplier identification is controlled by FDA SPL labeler/MAH data and NDC-to-labeler mapping rather than by brand name alone.
Which companies supply generic gentamicin ophthalmic products that substitute for GENTAK?
Answer (market-by-market): Generic supply is distributed across multiple manufacturers that market ophthalmic gentamicin sulfate under different NDCs. Generics are typically supplied by companies that obtain FDA approval for a given strength and dosage form and then supply distribution through wholesalers and pharmacy chains. A complete list requires NDC-level mapping and Orange Book linking to the exact strengths covered by GENTAK.
What dosage forms and strengths are relevant for GENTAK substitutes?
Common substitution groupings include:
- Ophthalmic ointment (gentamicin sulfate)
- Ophthalmic solution
- Equivalent strengths (varies by product and label)
Supplier lists differ across these groups because manufacturing and labeling are product-specific.
How do you identify the “supplier” behind the label for GENTAK in the supply chain?
In practice, “supplier” can mean different nodes:
- Market Authorization Holder (MAH) / labeler on the FDA listing
- Manufacturer of record on the label (including contract sites)
- API supplier for gentamicin drug substance (often multiple sources)
- Wholesaler/distributor channel partners for procurement
For litigation, procurement, or sourcing due diligence, the most actionable identifiers are:
- Labeler/MAH
- Manufacturing site(s) listed for the finished product
- API sourcing only if disclosed in filings or confirmed by documentation
What patents and regulatory listings determine who can supply gentamicin ophthalmic products?
Supply access for generics and biosafety-equivalent products depends on FDA regulatory status:
- Orange Book status for approved ophthalmic gentamicin products (generics submit ANDAs)
- Patent scope (if any still relevant for a given NDC/strength)
- Exclusivity windows for specific reference listed product presentations, if applicable
A supplier list tied to legal ability to market hinges on Orange Book product matches, not on gentamicin category knowledge alone.
How does Orange Book status affect generic entry risk for gentamicin ophthalmic?
When a listing is protected, generic entry requires:
- Patent expiration or non-infringement/invalidity positions (Paragraph IV)
- Patent carve-outs (if settlement or licensing permits entry for certain NDCs)
- Completion of required FDA review for the ANDA
A complete “who can supply” answer must therefore be product-and-NDC specific.
Which API producers supply gentamicin sulfate drug substance used in ophthalmic products?
Gentamicin API sourcing depends on:
- Fermentation and purification contracts
- DMF approvals for specific grades
- Downstream finished-product approvals that reference that API
A complete API supplier list requires DMF-linked sourcing to the specific finished-dose products. Brand name alone is not sufficient because finished product manufacturers can source API from multiple DMF holders over time.
How does GENTAK sourcing differ from antibiotic procurement for hospital formularies?
Hospital procurement often references:
- NDC
- manufacturer/labeler
- current availability
- contract purchasing agreements
- group purchasing organization (GPO) listings
This structure can cause “supplier” to be a distributor contract partner rather than the MAH, which changes depending on the procurement channel and geography.
Supplier risk and substitution: what breaks continuity of supply for gentamicin ophthalmic?
Operational disruption typically comes from:
- Finished-product manufacturing site constraints
- API fermentation batch availability and release timing
- Regulatory holds (quality investigations, sterility failures, or recall events)
- Labeler product discontinuation or NDC changes
A supplier risk view is strongest when tied to:
- Specific NDCs
- Manufacturing sites
- Recent FDA enforcement actions affecting those sites or product lots
Key Takeaways
- “Suppliers for GENTAK” is not a single roster because supplier identity depends on exact FDA product definition (dose form, strength, NDC).
- A reliable supplier map requires matching GENTAK presentation → FDA labeler/MAH → manufacturer of record and, if relevant, API DMF linkage.
- Generic substitution is driven by ANDA-approved ophthalmic gentamicin sulfate products, which means supplier lists are NDC-specific.
FAQs
- Which NDCs correspond to GENTAK ophthalmic gentamicin products and who is the labeler for each?
- What are the main manufacturers of generic ophthalmic gentamicin sulfate products that pharmacies use as GENTAK substitutes?
- How can procurement teams verify the manufacturing site for a given gentamicin ophthalmic NDC?
- Do gentamicin ophthalmic generics use the same API supplier across different brands and NDCs?
- What FDA Orange Book listings and patent expirations affect entry for specific gentamicin ophthalmic presentations?
References (APA)
- U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drug products. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
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