Suppliers and packagers for VERSACLOZ

VERSACLOZ

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Douglas Pharms	VERSACLOZ	clozapine	SUSPENSION;ORAL	203479	NDA	TruPharma LLC	52817-601-38	1 BOTTLE in 1 BOX (52817-601-38) / 100 mL in 1 BOTTLE	2018-06-15

Suppliers for VERSACLOZ (clozapine): API and finished-dosage manufacturing ecosystem, and what to check on the FDA label and Orange Book

Last updated: May 27, 2026

VERSACLOZ is a brand name for clozapine (oral tablets). Supplier mapping for a specific branded product is driven by (1) the FDA Approved Drug Products (Orange Book) listing for VERSACLOZ and (2) the NDA label “Manufactured for / Distributed by” and “Manufactured by” sections, which identify the finished-dose manufacturer(s) and sometimes additional sites for packaging.

Because you requested “Suppliers,” the actionable scope is: finished-dose manufacturers, label-disclosed packagers, and clozapine API suppliers. The only source that can be linked to a specific brand listing is the FDA labeling + Orange Book record for VERSACLOZ.

What companies supply VERSACLOZ tablets in the U.S.?

Direct supplier identification requires the VERSACLOZ FDA label and Orange Book listing. These documents list the company named on the label as manufacturer, and the site(s) used for manufacturing and packaging. Without the specific Orange Book/NDA entry for VERSACLOZ (strength-specific) and the exact label revision, a correct supplier roster cannot be produced.

What suppliers are typically listed for a clozapine brand like VERSACLOZ?

For an orally administered small molecule brand, the “supply” stakeholders usually split into three tiers:

1. Finished-dose manufacturer
   The NDA label section “Manufactured for” / “Manufactured by” identifies the site and firm responsible for the tablet manufacturing and site release.

2. Packager / labeler (if different)
   Some brands list a packaging/manufacturing site separate from bulk tablet manufacture.

3. API supplier
   The API vendor is often not disclosed in public FDA label sections for small molecules, though Orange Book sometimes lists applicant/holder and manufacturing information indirectly via site listings. API suppliers are more commonly disclosed in supplier qualification documentation, batch records, or specialty databases rather than in the public prescribing information.

Which API suppliers provide clozapine used in VERSACLOZ?

Clozapine API supplier names are not consistently disclosed in the public label/Orange Book. In U.S. public filings, API suppliers for small molecule branded tablets are typically not published as “suppliers” unless the record includes detailed manufacturing site information tied to an application.

How to determine the API supplier with public records for VERSACLOZ

For clozapine brands, the practical public-record pathway is:

• Orange Book listing for the exact VERSACLOZ strength and dosage form to identify the listed applicant/holder and sometimes manufacturing site(s).
• Label manufacturing statements to confirm the tablet maker and site.
• If the tablet manufacturer’s site is a contract manufacturer, that firm may source clozapine from one or more qualified API suppliers. Public records may not name the API supplier.

What Orange Book status does VERSACLOZ have, and does that affect supplier choices?

Orange Book exclusivity and patent status do not dictate suppliers directly, but they affect:

• Who is allowed to market the brand and therefore who holds supply contracts with that label
• Whether authorized generics or AB-rated generics compete, which changes procurement leverage and supply redundancy

Orange Book fields that matter for “suppliers”

When you pull the Orange Book entry for VERSACLOZ, the fields to extract are:

• NDA number
• Drug product name and strength
• Dosage form
• Applicant / holder
• Patent and exclusivity (expiration dates, active patents)
• Manufacturers and distributors (if listed)
• Dosage form equivalence across strengths

Are there multiple manufacturers for VERSACLOZ tablets by strength?

Brand clozapine tablet supply can vary by strength due to different batch requirements, packaging lines, and site qualification. If VERSACLOZ has more than one strength listed under the same NDA, the Orange Book listing may show different manufacturing sites.

Supplier mapping by strength typically looks like this

• Strength A: Tablet manufacturing site X; packaging site Y
• Strength B: Tablet manufacturing site X or Z; packaging site Y or W

That mapping is label- and site-specific.

How do you validate the true “suppliers” for VERSACLOZ from the label?

The prescribing information typically contains the manufacturer identity in one of these constructs:

• “Manufactured by [Company], [Site Address]”
• “Manufactured for [Company]”
• “Packaged by [Company]”
• “Distributed by [Company]”

For supplier diligence, you treat the label as authoritative for finished-dose and packaging. For API supplier identification, you treat it as incomplete unless the label or dossier references API sources.

What generic or authorized generic clozapine suppliers compete with VERSACLOZ?

Supply competition is usually from clozapine generic manufacturers under Orange Book ANDAs and from authorized generics in some segments. Supplier risk for VERSACLOZ procurement is therefore driven by:

• Whether the brand holds market share tightly vs. generics
• Whether multiple API sources exist for clozapine
• Whether contract manufacturing capacity is concentrated in one or two tablet makers

Key Takeaways

• VERSACLOZ is a clozapine brand; public “supplier” identification must be anchored to the VERSACLOZ Orange Book listing and the FDA label manufacturing sections.
• Public FDA materials reliably identify the finished-dose/tablet manufacturer(s) and sometimes packaging/labeling entities.
• Public materials do not consistently disclose the clozapine API supplier names.
• Supplier mapping can differ by strength based on manufacturing site qualification and packaging lines.

FAQs

1. How do I confirm the finished-dose manufacturer for VERSACLOZ tablets?
   Use the FDA-approved label “Manufactured by/Manufactured for/Packaged by” sections for the specific strength and label revision.

2. Does Orange Book list the company that manufactures VERSACLOZ tablets?
   It may list the applicant/holder and sometimes manufacturing-related details, but label sections are the most direct public disclosure for tablet manufacturing.

3. Are clozapine API suppliers disclosed for branded products like VERSACLOZ?
   They are often not disclosed in public label text; API supplier identification typically requires non-public dossier detail or specialty supplier databases.

4. Can different strengths of VERSACLOZ have different manufacturing sites?
   Yes. Brands often qualify multiple manufacturing or packaging sites by strength; confirm per strength in the label and Orange Book listing.

5. What documents provide the fastest supplier verification for VERSACLOZ?
   The Orange Book entry for VERSACLOZ and the latest FDA label for the specific strength.

References

(No sources were cited because no VERSACLOZ Orange Book label details were provided in the prompt.)