Suppliers and packagers for carafate

carafate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	CARAFATE	sucralfate	SUSPENSION;ORAL	019183	NDA	Allergan, Inc.	58914-170-14	420 mL in 1 BOTTLE (58914-170-14)	1993-12-16
Abbvie	CARAFATE	sucralfate	SUSPENSION;ORAL	019183	NDA	Allergan, Inc.	58914-170-60	6 CUP, UNIT-DOSE in 1 BOX (58914-170-60) / 10 mL in 1 CUP, UNIT-DOSE	1993-12-16
Abbvie	CARAFATE	sucralfate	SUSPENSION;ORAL	019183	NDA AUTHORIZED GENERIC	Pacific Pharma, Inc.	82182-106-14	420 mL in 1 BOTTLE (82182-106-14)	2024-02-01
Abbvie	CARAFATE	sucralfate	TABLET;ORAL	018333	NDA AUTHORIZED GENERIC	A-S Medication Solutions	50090-5287-0	60 TABLET in 1 BOTTLE (50090-5287-0)	2017-09-25

Suppliers and packagers for carafate

Last updated: May 29, 2026

Carafate (sucralfate) Suppliers: Who Manufactures, Where Are APIs Sourced, and What Are the Key Contract/Wholesale Channels?

Carafate is the brand name for sucralfate. Supplier coverage depends on whether you mean the finished dosage form (tablets/suspension), the sucralfate API, or distribution/wholesale channels. Based on the information available in public FDA labeling and typical branded supply chain practices, Carafate is supplied by the brand holder and its contract manufacturers, with sucralfate API sourced from qualified API plants through controlled intermediates and GMP supply agreements.

What’s protected matters for supplier identification: the drug product manufacturing, packaging, and labeling firms used for each NDC can change over time even when the active ingredient remains the same. Without specific NDC-level detail and without a current, itemized list of manufacturers for each strength and dosage form, a complete “who supplies what” mapping cannot be produced reliably.

Which companies supply Carafate tablets and suspension in the US?

Carafate supply in the US is typically handled through:

• The authorized holder of the brand (or marketing authorization/labeling responsibility in the US)
• One or more contract manufacturing organizations (CMOs) producing sucralfate drug product (tablets or oral suspension)
• Contract packaging and labeling sites
• US wholesalers/distributors that place Carafate into dispensing channels

Featured-snippet answer: Carafate is supplied by the brand’s US marketing authorization holder and its qualified contract manufacturers for each NDC, distributed through licensed wholesalers into retail and hospital channels.

What determines the “supplier” you actually get at pharmacy counter?

1. NDC-level manufacturing site (same brand, different NDCs can map to different manufacturing/packing facilities).
2. Dosage form and strength (tablet vs suspension changes formulation, fill-finish, and packaging).
3. Labeler/marketer vs manufacturer distinctions in US listings.

Who supplies sucralfate API used to make Carafate?

Sucralfate API is generally supplied by specialized API manufacturers or ingredient producers supplying sucralfate to multiple downstream finished-dose firms. API procurement usually uses:

• Qualified vendor lists under quality agreements
• DMFs or other CMC documentation tied to the API supplier
• Incoming material controls and batch release/testing

Featured-snippet answer: Sucralfate API is supplied by qualified API manufacturers to the drug-product makers through GMP supply arrangements, but the exact API source for Carafate depends on the drug product manufacturer tied to the specific NDC.

Why API “supplier” is not stable across Carafate batches

API sourcing can vary because of:

• Qualification cycles for alternative API suppliers
• Supply interruptions
• Batch-by-batch procurement decisions under GMP controls
• Regulatory documentation updates (CMC supplements)

What is the Orange Book status of Carafate and does it affect supplier sourcing?

Carafate’s presence in the FDA’s Orange Book affects generics and authorized generic competition, not direct API supplier identity. Supplier and manufacturing-site changes are possible without changing the patent estate, because the Orange Book does not list contract manufacturing sites for drug product.

Featured-snippet answer: Orange Book status is relevant to market competition and generic entry risk. It does not uniquely identify the current manufacturing supplier for each Carafate NDC.

How supplier identification is usually done in practice

Practitioners map suppliers using:

• FDA labeling and submission history tied to NDCs
• The package insert and labeler/manufacturer listings
• Product-specific regulatory submissions (CMC)
• NDC directory entries for manufacturing/packaging sites

What manufacturing and packaging sites produce Carafate for each NDC?

NDC-level manufacturing and packaging sites are the most actionable “supplier” inputs for:

• QA supplier audits
• CMC diligence for partnerships
• Litigation or recall tracing
• Cost and supply continuity planning

Featured-snippet answer: The supplier for Carafate is best defined at NDC granularity, where manufacturing and packaging sites are listed; without NDC-specific mapping, a full supplier table cannot be completed.

Typical NDC split that creates multiple suppliers

• Tablets often have one set of manufacturing/packing facilities per strength
• Suspension often has different fill-finish and packaging lines
• Labeling changes can cause additional packaging sites

Who distributes Carafate (wholesalers and channel partners)?

Distribution is handled by licensed wholesalers and specialty distributors. Brand distribution networks can include national wholesalers and regional hospital channel partners. Distributor identity matters for:

• Supply continuity and service levels
• Recall management
• Contracting and rebate terms
• Inventory availability during shortages

Featured-snippet answer: Carafate distribution is performed through licensed US wholesalers and channel partners aligned to each product NDC and distribution agreement.

Why distributor lists can change

Wholesaler selection is often influenced by:

• Contract structure with the brand holder
• Regional distribution footprints
• Demand forecasting and service-level commitments

How to map Carafate suppliers for procurement or licensing due diligence

For procurement and licensing, the supplier map needs three layers:

1. Drug product manufacturer for the exact NDC (tablets, suspension, each strength)
2. API supplier chain (API DMF-linked manufacturer(s) or intermediate sources)
3. Packager/labeler (and the warehouse/distribution chain if needed)

Featured-snippet answer: Build a supplier chain from NDC labeling and FDA submission-linked CMC sources, then validate with GMP certificates of analysis (COAs) and quality agreements.

Which supplier changes are common for sucralfate oral products?

Sucralfate is an older, established product class. Supplier change patterns include:

• Changing contract manufacturing sites due to capacity
• Packaging line migration due to facility upgrades
• Secondary packaging changes without reformulation
• Occasional API source changes under approved CMC updates

Featured-snippet answer: Manufacturing and packaging suppliers for Carafate can change over time at the NDC level, even if the active ingredient remains the same.

Key Takeaways

• Carafate supplier identification must be done at NDC and dosage-form level to name the actual manufacturing and packaging suppliers.
• API supplier identity depends on the drug-product manufacturer’s qualified vendor list for the specific NDC and batch.
• Orange Book status informs competition and exclusivity, not the immediate supplier plant producing your NDC.
• For procurement, QA, or licensing, the actionable approach is NDC-linked manufacturer/packager mapping plus API chain validation via CMC documentation and COAs.

FAQs

1. How do I identify the manufacturer of Carafate tablets vs Carafate oral suspension for my exact NDC?
2. Does Carafate have multiple NDCs with different contract manufacturing sites?
3. Can the sucralfate API supplier change while the Carafate brand remains the same?
4. How do distributors affect Carafate availability during shortages?
5. What documentation is typically required to qualify a new Carafate manufacturing or API supplier under GMP?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drugs@FDA. U.S. Food and Drug Administration.