Suppliers and packagers for ZOLINZA

Zolinza is a branded dermatology product (tazarotene topical). Key supplier identification depends on the specific marketed strength and dosage form and, in the US, on the FDA’s “Manufactured for” and “Distributed by” labels and the Orange Book listing for the approved product. No reliable, complete supplier roster can be produced from the information provided.

Which companies supply Zolinza manufacturing and distribution in the US?

Answer: Supplier identification for Zolinza requires the label “Manufactured for” and “Distributed by” entities tied to the approved NDC(s) for Zolinza. Those label strings are not provided in the input.

What does the Zolinza label typically list for suppliers?

Common supplier fields on US prescription product packaging include:

• Manufacturer (site-level or company-level, often “Manufactured by” or “Manufactured for”)
• Labeler (the company responsible for the NDC)
• Distributor (sometimes separate from labeler)
• Marketing authorization holder (for imports or repackagers, depending on supply chain)

Without the NDC and the specific dosage form strength, supplier entities cannot be stated accurately.

What is the Orange Book status of Zolinza and how does it map to suppliers?

Answer: Orange Book listings identify the NDA and listed patents and, indirectly, can be used to tie to the labeled manufacturer via the approved product record. The input does not include the Orange Book NDA number, so supplier mapping cannot be completed.

Why Orange Book alone may not identify raw-material suppliers

Orange Book records generally do not list:

• API suppliers
• excipient suppliers
• third-party fill-finish sources
• contract manufacturing organizations (CMOs) unless they appear in the product label

So even with Orange Book data, supplier coverage can remain partial unless label/NDC text is available.

Who supplies the tazarotene active pharmaceutical ingredient used in Zolinza?

Answer: The API supplier list cannot be compiled from the provided prompt.

What “API supplier” usually means in pharma procurement

Procurement teams typically want:

• named API manufacturer(s) (company and site, if disclosed)
• regulatory status (DMF/ASMF holder if disclosed on-label or in regulatory filings)
• supply constraints and dual sourcing status

Those facts are not present in the input.

Are there formulation-specific supplier constraints for Zolinza (cream vs gel)?

Answer: Supplier requirements differ by dosage form (for example, gel versus cream) because excipient systems, viscosity profiles, and packaging compatibility change. No Zolinza dosage form or strength is given, so supplier differentiation cannot be stated.

What typically changes supplier scope by dosage form

• Manufacturing process (mixing and homogenization requirements)
• Packaging components (materials compatible with tazarotene)
• Fill-finish operations (tube versus jar, nitrogen purge steps, etc.)

What generic or competitor suppliers affect Zolinza’s supply chain?

Answer: Competitive supplier dynamics (CMO capacity, API allocation, and contract bottlenecks) require:

• the approved Zolinza NDC set
• the competitor list for the same indication
• confirmed API and CMO overlap

None of these inputs are provided.

Key Takeaways

• Zolinza supplier identification requires product-specific label and NDC-linked details.
• With only the drug name “Zolinza” and no NDC/dosage form/strength, a complete and accurate supplier roster cannot be produced.
• Orange Book status and patent listings cannot substitute for label-level manufacturer and distribution data when the goal is “who supplies” the product and its supply-chain tiers.

FAQs

1. How can I identify the “manufactured for” company for Zolinza without the NDC?
   Zolinza’s manufacturer and labeler are printed on the package label tied to a specific NDC; without the NDC for the exact strength and dosage form, the entity cannot be determined from the name alone.

2. Does Orange Book list Zolinza API suppliers?
   Orange Book typically does not list API suppliers. It lists patents and the NDA record; API sourcing usually comes from DMF/ASMF and label documentation, not Orange Book.

3. Can Zolinza gel and cream use the same manufacturing supplier?
   Not always. Dosage form differences often change manufacturing line requirements and fill-finish suppliers, but verification requires product-specific labeling.

4. Who supplies packaging for Zolinza tubes/containers?
   Packaging component suppliers are rarely disclosed in public databases; they are usually identified through procurement disclosures or regulatory filings tied to the exact NDC and packaging configuration.

5. Do authorized generics of tazarotene compete for the same API supply?
   They can, depending on API allocation and CMO/API sourcing overlap, but determining overlap requires a mapping of API and manufacturing networks for each product variant.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book).