Suppliers and packagers for CYCLOSET

CYCLOSET

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866	NDA	Avvisto Therapeutics LLC	73515-123-21	21 TABLET in 1 BOTTLE (73515-123-21)	2024-05-23
Veroscience	CYCLOSET	bromocriptine mesylate	TABLET;ORAL	020866	NDA	Avvisto Therapeutics LLC	73515-123-30	200 TABLET in 1 BOTTLE (73515-123-30)	2024-05-23

Suppliers for CYCLOSET (bromocriptine) in the US: API, finished-dose, and key manufacturing/IP risks

Last updated: May 30, 2026

CYCLOSET is an oral bromocriptine hydrochloride product (timed-release) marketed by required regulatory pathway via FDA’s Orange Book listings for innovator exclusivity. Supplier mapping for CYCLOSET must be anchored to FDA registration data, Orange Book listed drug manufacturers (for the NDA holder and any listed manufacturing sites), and Drug Master File (DMF) use or contract manufacturing disclosures. Without Orange Book, FDA Establishment Registration and Listing (EPLS) data, and assignment-level manufacturing/DMF references, supplier identification cannot be completed accurately to the standard required for R&D sourcing, licensing, or litigation decisions.

No complete supplier list can be produced from the information provided.

What suppliers make CYCLOSET bromocriptine API and finished tablets/capsules?

Featured snippet answer: Supplier identification requires Orange Book “Manufacturer”/“Applicant” and FDA EPLS site registrations for the specific dosage form strength listed for CYCLOSET, plus any DMF-backed excipient or API route attribution.

How to identify CYCLOSET suppliers from Orange Book listings

Orange Book (Listed Drug, NDA holder, strengths, dosage forms) typically indicates:

• Applicant/NDA holder
• Dosage form and strength
• Listed manufacturing sites (if listed by the applicant)
• Patent-related exclusivity context that can affect authorized generic and sourcing timing

How DMFs change the “who supplies what” answer

For bromocriptine-based products, contract manufacturing and DMF use can split:

• API manufacture (DMF-backed bromocriptine intermediate and final API)
• Finished-dose manufacture (tabletting, coating, and controlled-release/time-release technology)
• Packaging and labeling (often separate site registrants)

Which companies supply bromocriptine hydrochloride API for CYCLOSET?

Featured snippet answer: This cannot be stated precisely without:

• Orange Book manufacturing site names for the CYCLOSET NDA strengths
• FDA EPLS manufacturing site registrations tied to the NDA and dosage form
• DMF referents for bromocriptine API and key intermediates
• Published vendor qualifications or CMO disclosures

Who manufactures CYCLOSET finished dosage form (timed-release) in the US?

Featured snippet answer: The finished-dose manufacturer must be identified by FDA registration/EPLS site records that correspond to the NDA’s dosage form and strength. Timing-release products also frequently use specialized coating or matrix technology supplied by a defined CMO.

Formulation and manufacturing steps that drive supplier selection

Supplier selection for timed-release bromocriptine products typically depends on:

• Controlled-release coating and process capability
• Blending and granulation or pelletization capability
• Film coating/coating curing controls
• Stability and release profile validation
• Batch size and scale-up history

What is the Orange Book status of CYCLOSET and how does it affect supplier availability?

Featured snippet answer: Orange Book status affects:

• Authorized generic risk
• Settlement-driven sourcing changes
• Parallel manufacturing authorizations for generic or AB-rated competitors

Exclusivity and patent landscape that can constrain sourcing

If CYCLOSET has active listed patents or exclusivity tied to:

• Method of use
• Formulation/device
• Controlled-release composition or process then some manufacturing work is restricted to authorized parties or under license terms.

What generic entry risks exist for CYCLOSET that would change sourcing suppliers?

Featured snippet answer: Generic entry risk affects supplier leverage and redundancy only if:

• There are Paragraph IV ANDAs with exclusivity or litigation histories that force settlements
• Contract manufacturing capacity becomes multi-sourced due to potential AB substitution

What to monitor for sourcing shifts

• ANDA approvals and launch dates
• Contract manufacturing reallocations after patent expiry or settlement
• NDA-to-ANDA supplier transfers recorded in registration listings

Where can CYCLOSET suppliers be verified (FDA registration, labels, and compendia)?

Featured snippet answer: Verification requires triangulation from:

• FDA’s Orange Book “Listed Drug” manufacturer fields
• FDA SPL product labels (packager/labeler)
• FDA EPLS site registration records tied to the NDA
• DMF holder or referent links (if accessible through references or public dossiers)

Evidence hierarchy used for supplier mapping

1. FDA Orange Book manufacturing site listing for the CYCLOSET NDA and strength
2. FDA EPLS registration site tied to that NDA/dosage form
3. Labeler/packager shown on FDA-approved labeling (SPL)
4. Public CMO/DMF references in submissions where available

Key takeaways

• A supplier list for CYCLOSET cannot be produced accurately without FDA Orange Book manufacturing entries, FDA EPLS site registrations, and any DMF-linked API/processing attribution.
• Supplier identification must be validated to the specific dosage form and strength listed for CYCLOSET in the Orange Book, not by generic bromocriptine market assumptions.
• Supplier risk for sourcing and litigation exposure depends on whether CYCLOSET’s listed patents/exclusivity constrain manufacturing authorization or shift capacity via settlements or authorized generics.

FAQs

1. How do I confirm the labeler/packager for CYCLOSET from FDA SPL data?
2. Which FDA databases show manufacturing site registrations for bromocriptine timed-release products?
3. How do DMFs affect who supplies bromocriptine API versus who makes the finished CYCLOSET dose?
4. What Orange Book fields should be used to map finished-dose manufacturers for a listed drug?
5. How do Paragraph IV filings for bromocriptine timed-release products change contract manufacturing availability?

References

No sources were used because no FDA/Orange Book/EPLS or DMF records were provided in the prompt.