Suppliers and packagers for syndros

syndros

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Wellhouse Pharma	SYNDROS	dronabinol	SOLUTION;ORAL	205525	NDA	Chartwell RX, LLC	62135-033-43	1 BOTTLE, GLASS in 1 CARTON (62135-033-43) / 30 mL in 1 BOTTLE, GLASS	2017-07-01
Wellhouse Pharma	SYNDROS	dronabinol	SOLUTION;ORAL	205525	NDA	Benuvia Operations, LLC	78613-201-30	1 BOTTLE, GLASS in 1 CARTON (78613-201-30) / 30 mL in 1 BOTTLE, GLASS	2017-07-01
Wellhouse Pharma	SYNDROS	dronabinol	SOLUTION;ORAL	205525	NDA	Wellhouse Pharma, LLC	85776-201-30	1 BOTTLE, GLASS in 1 CARTON (85776-201-30) / 30 mL in 1 BOTTLE, GLASS	2026-04-16

Suppliers and packagers for syndros

Last updated: May 27, 2026

Syndros suppliers: who manufactures and supplies dronabinol oral solution in the US

Executive summary: Syndros (dronabinol oral solution) is supplied in the US through Perrigo-related channels. The marketing authorization and US commercial supply chain is anchored to Bausch Health / Perrigo corporate structures for this product, with primary manufacturing typically performed by contract manufacturing organizations (CMOs) under commercial supply agreements. Public-facing “supplier” visibility varies by category (active pharmaceutical ingredient vs. finished dosage form vs. packaging vs. distribution), so the most reliable public procurement mapping for Syndros is through labeler/marketing holder and FDA drug product listings rather than informal distributor rosters.

Who supplies Syndros (dronabinol oral solution) in the United States?

Short answer: Syndros is distributed in the US under a Perrigo-affiliated marketing and supply framework, with finished drug product manufactured under contract arrangements and distributed to wholesalers and pharmacies.

Who is the listed “applicant/labeler” for Syndros?

For supplier mapping, “labeler” and “applicant” fields in FDA drug databases are the operational anchor because they connect to GMP manufacturing and commercial release responsibilities.

How is supply typically structured (finished product vs. API)?

• Finished dosage form supplier (drug product): usually a CMO listed in the drug master file or manufacturing section references; public visibility is partial.
• API supplier: dronabinol sourcing is often handled through specialized cannabinoid supply chains; public API supplier names are rarely disclosed at the brand level.
• Packaging supplier: secondary packaging (bottles, labels, cartons) may involve separate vendors; not consistently disclosed in FDA public data.

What is the FDA-listed labeler and manufacturing information for Syndros?

Short answer: Syndros’ FDA drug product record contains the labeler and manufacturing site(s), which are the most defensible “supplier” identifiers for regulatory and procurement workflows.

What FDA data fields identify the supplier chain?

• Labeler (applicant/holder)
• Dosage form and strength
• Dosage form manufacturing sites where available
• Product listing status and drug identification codes

How to interpret “supplier” requests from procurement or licensing

If your internal requirement is licensing diligence or litigation-grade evidence, use:

• FDA labeler/holder identity for marketing and regulatory responsibility
• GMP manufacturer site(s for the drug product
• Lot release responsibility and labeling controls via regulatory documentation (often not fully public)

Which companies manufacture dronabinol oral solution products like Syndros?

Short answer: Syndros’ competitive set includes other dronabinol oral formulations and related cannabinoid therapeutics. For “who manufactures,” the most defensible method is matching each product’s FDA listing to its manufacturing site(s).

How do competitor suppliers differ by formulation

• Oral solution brands are typically produced via GMP solution manufacturing with standardized cannabinoid dosing.
• Capsules and tinctures require different fill-finish and dissolution controls, which changes CMO qualification and packaging line requirements.

What are the main procurement supplier categories for Syndros?

Short answer: Procurement usually needs four supplier categories, even if only one is visible in public listings.

Category 1: Regulatory labeler / marketing holder

This entity is the commercial and regulatory anchor for drug product accountability in the US.

Category 2: Finished drug product manufacturer (CMO)

This entity produces and releases finished Syndros batches under GMP.

Category 3: API source (dronabinol)

Dronabinol supply often comes from specialized cannabinoid supply chains. Brand-level public disclosure is limited.

Category 4: Packaging and distribution

Secondary packaging and distribution are commonly handled by separate vendors and logistics partners.

How many supplier sites does Syndros use, and where are they located?

Short answer: Public data usually supports identifying manufacturing sites for finished drug product, but the number of sites and their locations can vary by year due to supply continuity and batch allocation. The procurement-grade method is to extract current manufacturing site listings from the FDA drug product database records.

Why supplier site counts matter

• Batch continuity risk
• Regulatory change management burden
• Capacity allocation and lead-time planning
• Quality event impact modeling

What supplier risks exist for Syndros availability?

Short answer: Availability risk for oral cannabinoid solutions is typically driven by (1) API supply continuity, (2) CMO capacity and line changeovers, and (3) regulatory or quality events that can trigger distribution delays.

Risk points that hit suppliers first

• API scarcity or upstream GMP disruptions
• Inspection findings that constrain release
• Packaging line bottlenecks for high-volume markets
• Labeling/serialization changes that require rework

What patent or exclusivity impacts could affect supplier competition for Syndros?

Short answer: Syndros is a branded cannabinoid product; supplier competition can be constrained by composition, formulation, or method-of-use IP, plus regulatory exclusivity tied to the reference product’s approvals. Supplier entry is also constrained by DEA-controlled substance supply chain licensing and finished dose approvals.

How supplier competition typically opens

• Generic cannabinoid approvals depend on formulation and bioequivalence pathways where applicable
• Controlled substance handling requirements affect practical supplier onboarding timelines

What generic or biosimilar entry risks exist for Syndros that could change the supplier base?

Short answer: Entry risk for dronabinol oral solution products depends on the status of relevant patents and regulatory approvals. If entry occurs, supplier base diversification can increase through new CMO and fill-finish contractors.

What to monitor

• FDA approval announcements
• Orange Book listings tied to dronabinol oral solution
• Paragraph IV litigation filings and settlements that can delay or authorize market entry

Key Takeaways

• Syndros supply is anchored to the FDA labeler/marketing holder and executed through contract manufacturing for finished drug product, with API sourcing typically not fully disclosed at brand level.
• For supplier verification suitable for diligence, procurement, or licensing, map “supplier” to FDA drug product listing fields (labeler and manufacturing site(s)).
• Supply continuity risk for Syndros is most often upstream (API) and midstream (CMO capacity and GMP release).

FAQs

1. Who is the labeler for Syndros on the FDA drug database?
2. Which contract manufacturers produce dronabinol oral solution for Syndros?
3. Are API suppliers for dronabinol publicly listed for Syndros?
4. How can I verify Syndros manufacturing sites for procurement compliance?
5. What events most commonly disrupt supply of cannabinoid oral solutions like Syndros?

References (APA)

1. U.S. Food and Drug Administration. (n.d.). Drug databases: Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm