Suppliers and packagers for CARAC

CARAC

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Extrovis	CARAC	fluorouracil	CREAM;TOPICAL	020985	NDA AUTHORIZED GENERIC	Dr. Reddy's Laboratories Inc.	75907-169-11	1 TUBE in 1 CARTON (75907-169-11) / 30 g in 1 TUBE	2025-07-06

Suppliers and packagers for CARAC

Last updated: June 7, 2026

Carac (fluorouracil topical) suppliers: who makes the drug, key raw-material inputs, and contract manufacturing landscape

Carac is a topical anti-neoplastic product with fluorouracil (5-FU) as the active ingredient. Supply is typically split across (1) API manufacture of fluorouracil, (2) fill-finish/finished dosage manufacturing for the cream (0.5%) strength, and (3) specialty packaging and distribution.

Who supplies the active ingredient for Carac (fluorouracil)?

Fluorouracil API supply is concentrated in a small number of qualified API manufacturers and chemical intermediates producers globally. Finished-goods suppliers (the firms marketing Carac) often outsource API sourcing to these API manufacturers and then contract finished-dose manufacturing.

Typical supply chain structure

• Fluorouracil API manufacturer(s): produce fluorouracil bulk drug substance (often via urea/uracil-related or pyrimidine-route chemistries depending on the commercial producer).
• API repackagers/wholesalers: provide supply continuity and quality documentation for finished-dose manufacturers.
• Contract manufacturing organization (CMO) for topical semisolid: formulates 0.5% w/w fluorouracil cream and manufactures/holds bulk and fills tubes.
• Packager: supplies tubes, caps, labels, and tamper-evident features for US distribution.

Which companies supply the finished Carac drug product (0.5% cream)?

Carac is marketed as a branded topical drug product; the commercial “supplier” you need for procurement, contracting, or risk analysis is typically the ANDA/BLA labeler and the manufacturing site(s) listed on FDA databases.

However, with the information provided in the prompt (“carac” only), there is no reliable way to name the specific labeler/manufacturer, API supplier, or CMO without pulling the FDA Orange Book / drug listing / labels and matching the exact NDC(s) for the marketed presentations.

How to identify Carac suppliers in the US (Orange Book, labels, NDC mapping)

Carac supply mapping depends on:

• Exact NDC (product strength, pack size, dosage form, labeler)
• FDA Label (package insert) and Drug Listing record (manufacturer and distributor)
• Orange Book listing (patent owner and applicant; often different from the physical manufacturer)
• CGMP manufacturing site addresses shown on labels

What Orange Book status does Carac have and how does it affect supply?

Orange Book entries drive:

• who holds the reference listed drug (RLD) designation
• who controls brand exclusivity and patent estates
• who can file generics or 505(b)(2) pathways tied to the same RLD

But supplier identification requires the exact listing record.

What generic/CDMO supply risks exist for Carac?

Supply risk for semisolid topical oncology products generally concentrates in:

• limited qualified sites for semisolid CGMP manufacture
• API procurement for fluorouracil (availability volatility, quality requalification cycles)
• tube/packaging lead time
• regulatory inspection outcomes that affect batch release

Without NDC- and label-level data, the named supplier set cannot be validated.

Is Carac supplied by multiple manufacturers or one site?

Branded topicals sometimes use:

• multiple fill-finish sites across regions to manage volume and logistics
• CMO manufacturing plus in-house labeling/distribution
• seasonal lot switching where packaging vendors change but the active dosage manufacturing remains constant

A validated multi-site supplier list must be constructed from FDA label manufacturers per NDC.

Carac vs. other 5-FU topicals: does supplier overlap occur?

In topical oncology, supplier overlap can happen when:

• the same CMO formulates multiple strengths for different labelers
• the same API producer supplies multiple finished-dose manufacturers
• packaging vendors are shared across brands

Name-level comparisons require NDC-level mapping for each competitor product.

Commercial action: what supplier set to lock for procurement or contracting

For an actionable sourcing plan, the supplier categories to lock are:

1. Finished-dose manufacturer (label-listed manufacturer) for Carac cream 0.5%
2. API fluorouracil drug substance manufacturer(s) or the API holder supplying certificates of analysis
3. Packaging/tube supplier (validated components and change-control history)
4. Quality agreement owners for incoming material and batch release

But naming specific companies requires FDA-label-derived entity IDs for Carac’s exact NDC.

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Key Takeaways

• Carac’s supply chain is structured around fluorouracil API production, semisolid topical CGMP manufacturing, and tube/label packaging.
• Exact identification of which companies supply Carac finished product, and which suppliers provide fluorouracil API and packaging, requires the specific Carac NDC(s) and their FDA label/manufacturer listings.
• Without NDC- and label-level mapping, naming supplier companies would be speculative.

FAQs

1. Where can I verify the Carac manufacturer listed for my specific NDC?
2. Who typically manufactures fluorouracil API used in US topical drugs?
3. Do Carac lots come from multiple manufacturing sites under the same labeler?
4. What are the main supply bottlenecks for fluorouracil topical creams?
5. How can I map Carac supplier changes during shortages or reallocations?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drugs@FDA: FDA Approved Drug Products. U.S. Food and Drug Administration.
3. FDA. DailyMed: Package Label/Drug Label Information. U.S. National Library of Medicine.