Suppliers and packagers for TARGRETIN

TARGRETIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	TARGRETIN	bexarotene	CAPSULE;ORAL	021055	NDA	Bausch Health US, LLC	0187-5526-75	1 BOTTLE in 1 CARTON (0187-5526-75) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE	1999-12-29
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056	NDA	Bausch Health US, LLC	0187-5525-60	1 TUBE in 1 CARTON (0187-5525-60) / 60 g in 1 TUBE	2000-06-28

Suppliers and packagers for TARGRETIN

Last updated: May 29, 2026

Targretin (bexarotene) Suppliers: API and Finished-Dose Manufacturers, Contract Suppliers, and Supply Risks

Targretin (bexarotene) supply in the US is driven by (1) the branded manufacturer’s supply chain for finished product and (2) upstream API and excipient sources used by generic or repackaged products. The supplier set is determined by the specific listed national drug code (NDC) strength/formulation, current FDA labeling, and the Orange Book’s listed application holders and manufacturers for each product.

Who manufactures Targretin (bexarotene) finished product in the US?

Featured answer: Targretin is a branded bexarotene product marketed under the Allergan/Valeant brand history and historically manufactured through established contract manufacturing networks for oral soft capsules. The active ingredient is bexarotene; the dosage form is oral soft capsules.

What is the Targretin dosage form and strength that determines “who supplies it”?

Targretin is supplied as oral soft capsules containing bexarotene. Supplier identification depends on which NDC/strength is procured because different strengths may map to different finished-goods sites and packaging runs.

What “supplier” means in procurement terms

For sourcing, “suppliers” split into:

• Finished-dose manufacturer (site that produces and packages the soft capsules under the application)
• Repackager/labeler (where applicable)
• API manufacturer(s) for bexarotene
• Contract packager(s) and logistics vendors tied to the specific NDC

Which companies supply bexarotene API for Targretin and bexarotene generics?

Featured answer: Bexarotene API suppliers are typically specialized small-molecule API manufacturers with capabilities in aromatic nitrile, halogenated aromatics, and controlled crystallization or purification steps. The exact API vendor set for branded Targretin is product-NDC specific and controlled by confidential supply agreements and cGMP commercial contracts, so procurement diligence is done via supplier qualification dossiers and FDA commercial manufacturing listings.

What to extract from FDA and commercial sourcing records

For each bexarotene-containing product (branded and generic), identify:

• Application holder (ANDA holder or NDA holder)
• Listed manufacturing site(s) for dosage form
• API/manufacturing site fields where publicly listed
• Changes in manufacturing post-approval (site transfers, CMO onboarding, packaging changes)

What does the Orange Book listing tell you about Targretin supply chain manufacturers?

Featured answer: The Orange Book does not list “CMOs” in a procurement sense unless they are the listed manufacturing sites. It is still a primary starting point because it identifies the approved application holder and provides manufacturing information that can be used to trace the finished-dose supply chain.

How to map Orange Book fields to supplier discovery

• Start with the NDA entry for Targretin and confirm the listed applicant/holder.
• Cross-check listed manufacturers tied to the dosage form and strength.
• Use FDA manufacturing site changes (supplement approvals) to detect supply-site switching.

Are there generic or repackaged bexarotene capsule products that change supplier options?

Featured answer: Yes. The US market includes bexarotene capsule products outside the branded label, which broadens supplier options for oral soft capsules and changes the practical procurement supplier set.

Why supplier lists differ by procurement channel

• Wholesalers may carry multiple NDCs across different application holders.
• Hospital formularies often standardize a specific NDC, which constrains supplier options.
• Shortages trigger NDC substitution, which changes the effective supplier set.

How do you identify the current finished-dose manufacturer for a specific Targretin NDC?

Featured answer: Use the NDC-specific label and FDA listing to identify the listed manufacturer for that strength, then validate through CoA release site on purchase orders.

Procurement workflow that surfaces the real supplier

• Verify the exact NDC from the label and purchase specification.
• Pull the FDA listing for that NDC to map to the listed manufacturer site.
• Confirm on CoA: “Manufactured by” and “Distributed by” fields plus the testing lab site.

What manufacturing/IP barriers affect sourcing of bexarotene capsules?

Featured answer: For branded oral soft capsules, supplier barriers come from (1) formulation/process IP around bexarotene solubilization and capsule filling and (2) approval-time manufacturing controls rather than standalone API-only restrictions.

Where supply bottlenecks typically occur

• API batch consistency (crystal form, purity specs)
• Encapsulation process (softgel filling, bead formation, curing parameters)
• Scale-up constraints during site transfers
• Packaging-line capacity for the specific strength NDC

What are the main supply risks for Targretin (bexarotene) procurement?

Featured answer: Supply risk is tied to small-molecule API availability, softgel encapsulation capacity at limited CMO sites, and NDC-specific production constraints.

Risk drivers

• API production interruptions for upstream specialty synthesis intermediates
• Softgel manufacturing line availability and staffing
• Quality deviations that lead to batch holds
• Regulatory changes or site transfer timelines that extend release delays

How strong is the supplier ecosystem for bexarotene compared with other retinoids?

Featured answer: The bexarotene ecosystem is smaller than higher-volume retinoids due to its specialty oncology/dermatology usage, which reduces CMO and distributor redundancy.

Commercial implication

Fewer qualified softgel lines and fewer API sources increases the impact of:

• a single-site disruption
• an API yield issue
• a packaging changeover affecting that NDC

Which suppliers matter most if you are bidding for Targretin supply (RFP view)?

Featured answer: The “suppliers that matter” are the companies that control release and packaging for the specific NDC, plus upstream API makers that can supply bexarotene with the required impurity profile.

Supplier qualification target list

1. Finished-dose manufacturer site(s) for the NDC strength
2. Softgel encapsulation and packaging CMO(s) named in CoA/manufacturing statements
3. API vendor(s) that can meet release specs and lead-time
4. QA release testing site(s) capable of handling bexarotene’s impurity requirements

Key Takeaways

• Targretin supplier identification is NDC-specific: finished-dose manufacturer and packaging site can differ by strength.
• Orange Book listings help map the application holder and approved manufacturing sites that anchor supplier tracing.
• Upstream bexarotene API sourcing and downstream softgel encapsulation capacity are the core constraints that shape supplier availability.
• Procurement risk concentrates in limited softgel and specialty API ecosystems rather than broad commodity supply chains.

FAQs

1. How do I find the manufacturer site for Targretin for a specific strength NDC?
   Pull the NDC on the label, map to the FDA listing for that NDC strength, then confirm against the CoA “manufactured by” and testing fields.

2. Are there multiple bexarotene capsule suppliers besides Targretin brand?
   Yes, the market includes non-branded and alternative application-holder products, changing the effective sourcing pool.

3. What causes Targretin softgel supply shortages?
   Common drivers include API supply disruption, softgel line capacity constraints, batch quality deviations, and NDC-specific packaging bottlenecks.

4. Does the Orange Book list API suppliers for bexarotene?
   It may list manufacturing sites tied to approvals, but it is not a complete API vendor directory for all commercial supply chains; supplier qualification records and CoAs do the final mapping.

5. What specs matter most when qualifying bexarotene API for capsule filling?
   Purity/impurity profile, crystal form consistency, and residual solvents align with capsule filling performance and regulatory release requirements.

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). US FDA.
2. FDA Labeling and NDC Directory for Targretin (bexarotene) soft capsules. US FDA.