Last updated: May 26, 2026
CYCLOGYL is a cyclopentolate hydrochloride ophthalmic product used for mydriasis/cycloplegia. Supplier identification depends on the labeled manufacturer/packager and, for branded supply risk, the current FDA NDC/Orange Book listings tied to each strength and dosage form. No complete, verified supplier list can be produced from the provided prompt alone.
Which companies supply CYCLOGYL (cyclopentolate) ophthalmic in the US?
The supplier set for CYCLOGYL is determined by the company listed as the applicant/holder and the listed manufacturer and packager for each NDC and strength on the FDA label and NDC directory. Those entities can change across lots due to contract manufacturing and repackaging.
What supplier roles exist in ophthalmic (cyclopentolate) product supply chains?
- Labeler/applicant (FDA submission holder)
- Manufacturer (site that makes the drug product)
- Packager (site that fills/finishes and packages)
- Sterile manufacturing control (for ophthalmic, typical sterile process and container closure integrity testing)
- Distribution hubs (often not visible in FDA data, but can affect “supplier” in commercial terms)
What NDCs correspond to CYCLOGYL and which manufacturers are listed?
Supplier discovery for CYCLOGYL must be done at the NDC level because the same brand name can map to multiple strengths, package configurations, and labelers. Supplier names also vary by NDC.
What Orange Book status does CYCLOGYL have, and does it affect suppliers?
Orange Book listings can indicate whether a branded product is tied to exclusivity or listed patents, which can affect entry and the number of supply sources. Cyclopentolate products are often mature and may not have current blocking exclusivity, but this must be confirmed per specific NDC/labeler.
How do patent/exclusivity timelines affect supplier count?
- If patent/exclusivity blocks generic substitution, supply is often limited to one or two branded labelers and a small contract manufacturing base.
- If no blocking protections exist, additional manufacturers can supply the same active ingredient and strength under abbreviated regulatory pathways, increasing the pool of suppliers.
How do you identify contract manufacturers for CYCLOGYL (cyclopentolate) ophthalmic?
For ophthalmics, contract manufacturing is usually reflected through:
- FDA drug establishment registration and listing linked to the finished dosage labeler
- Label “Manufactured for” or “Distributed by” statements on the carton and insert
- Lot-specific labeling changes when supply contracts shift
What generic or AB-rated alternatives to CYCLOGYL exist, and who supplies them?
Commercial “supplier” risk often tracks the availability of AB-rated generics with the same active ingredient, dosage form, and strength. Those can come from different labelers and different contract manufacturing sites even when the brand name remains unchanged.
Which factors determine whether alternatives will mitigate CYCLOGYL supply risk?
- Sterile fill-finish capacity for ophthalmic drops
- Container closure system qualification for multidose or unit-dose formats
- Shortages driven by API and excipient availability
- Regulatory status and quality history of alternative suppliers
What FDA and regulatory signals indicate supplier constraints?
Supplier constraints can be inferred from:
- FDA enforcement actions and recalls affecting specific manufacturing sites
- Drug shortage designations that map to specific NDCs and manufacturers
- Changes in FDA drug establishment registrations tied to manufacturing site activity
Key Takeaways
- “Suppliers for CYCLOGYL” is not a single fixed list; it is NDC- and strength-specific and changes with labeler, contract manufacturing, and repackaging.
- The authoritative supplier set must be pulled from FDA labeler/manufacturer/packager fields and NDC mappings for the specific CYCLOGYL strength and package.
- Patent and exclusivity status (Orange Book) can materially affect how many companies can supply the same product configuration, but it must be confirmed per NDC.
FAQs
-
How can I find the manufacturer for a specific CYCLOGYL NDC?
Use the FDA label and NDC directory record for that exact NDC, then read the “Manufactured by/for” and labeler fields.
-
Do cyclopentolate ophthalmic brands have different suppliers by strength?
Yes. Even within the same brand name, different strengths and pack sizes can map to different labelers and manufacturing sites.
-
Are CYCLOGYL and generic cyclopentolate ophthalmic interchangeable for supply planning?
Only if the alternative is AB-rated and matches active ingredient, dosage form, and strength as listed for the relevant NDC.
-
Can contract manufacturers supply multiple ophthalmic products with the same cyclopentolate API?
Yes. Contract manufacturing sites often fill multiple ophthalmic SKUs, so supplier substitution can depend on fill-finish capacity and regulatory authorization.
-
What indicates a CYCLOGYL shortage will persist across suppliers?
Shortage designations tied to multiple NDCs and manufacturing sites, combined with repeated replenishment delays linked to the same sterile capacity constraints.
References (APA)
- FDA. (n.d.). Drug shortages. U.S. Food and Drug Administration.
- FDA. (n.d.). NDC directory. U.S. Food and Drug Administration.
- FDA. (n.d.). Drugs@FDA (label and approval history). U.S. Food and Drug Administration.
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
