Suppliers and packagers for zipsor

zipsor

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Assertio Speclty	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202	NDA	Assertio Therapeutics, Inc.	13913-008-12	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (13913-008-12)	2009-06-16
Assertio Speclty	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202	NDA AUTHORIZED GENERIC	Leading Pharma, LLC	69315-275-20	120 CAPSULE, LIQUID FILLED in 1 BOTTLE (69315-275-20)	2022-03-24
Assertio Speclty	ZIPSOR	diclofenac potassium	CAPSULE;ORAL	022202	NDA AUTHORIZED GENERIC	Bryant Ranch Prepack	71335-2550-1	30 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-2550-1)	2022-03-24

ZIPSOR (diclofenac potassium) Suppliers and Manufacturing Sources: Who Makes the Product and What Supply Risks Matter

Last updated: May 23, 2026

ZIPSOR is diclofenac potassium (an oral NSAID) supplied through a drug-product supply chain typical for small-molecule, branded generics-style sourcing. Public-facing “supplier” visibility depends on how the label identifies the manufacturer (drug substance vs drug product), how the product is listed in FDA systems, and whether contract manufacturing is used for commercial scale.

What companies supply ZIPSOR (diclofenac potassium) drug product to the U.S. market?

Featured snippet answer: ZIPSOR’s U.S. supply is tied to the company listed as the drug product manufacturer on the prescribing information and corresponding FDA labeling, with potential contract manufacturing for finished dosage form.

How to identify ZIPSOR “supplier” in practice

For acquisition due diligence, the relevant “supplier” is typically one of these:

• The company listed in FDA labeling as the manufacturer, packager, or distributor on the ZIPSOR prescribing information and carton labeling.
• The facility tied to FDA inspections for the finished dosage form (if publicly linked to that manufacturer).
• The labeler of record in FDA databases, which often corresponds to the marketing authorization holder even when the finished product is contract manufactured.

Key supplier concepts investors and litigators track

• Drug product vs drug substance: diclofenac potassium drug substance may come from a different site than the tablet/packaging.
• Contract manufacturing: “supplier” can change across lots without changing the brand labeler of record.
• Site-specific compliance: an identified manufacturer may shift due to remediation or supply disruption.

What does the Orange Book list for ZIPSOR suppliers and manufacturing details?

Featured snippet answer: The Orange Book typically links ZIPSOR to the NDA/marketing authorization and lists patent and exclusivity data; it does not consistently provide a complete supplier map, but it ties to FDA application-level information that can be crosswalked to labeler and manufacturer fields.

Orange Book data fields that help with supplier mapping

• NDA holder/labeler
• Product type (drug, dosage form)
• Listing type (patent and exclusivity records)
• Application-level identifiers used to pull labeling in other FDA systems

Why this matters for supply continuity

If the NDA holder changes or a manufacturing site changes, it can coincide with:

• contract transitions
• scale-up/scale-down
• CAPA-driven site requalification

Which NDA holder and labeler of record markets ZIPSOR?

Featured snippet answer: ZIPSOR is marketed under an NDA for diclofenac potassium with an associated holder/labeler of record. The practical supplier identity is the drug product manufacturer listed on the label for the finished dosage form.

What to look for on ZIPSOR cartons and prescribing information

• Name and address of manufacturer or packager
• “Distributed by” vs “Manufactured by” distinctions
• Label revision dates and lot numbering practices

What manufacturing sites or contract manufacturers make ZIPSOR tablets?

Featured snippet answer: ZIPSOR’s finished dosage form is manufactured at the site(s) named on FDA labeling for the product. Contract manufacturing may be used, but a definitive list requires label-to-facility mapping.

How to map labeler to facility

• Identify the manufacturer name on prescribing information.
• Tie the manufacturer name to FDA inspection and establishment records.
• Cross-check whether the same establishment makes multiple diclofenac products.

Common small-molecule supply-chain patterns for branded NSAIDs

• API supplier and finished-dose supplier differ
• Packaging may be done by a third party
• Finished-dose production can shift among qualified sites

When does ZIPSOR lose exclusivity, and how does that change suppliers?

Featured snippet answer: Exclusivity loss can change purchasing leverage and procurement options as more supply sources compete after patent and exclusivity barriers fall.

Supply-side impacts after exclusivity or patent expiration

• Increased generic/authorized generic competition can pressure pricing and increase procurement consolidation.
• The originator’s supplier network may add alternate manufacturing sites to maintain volume.
• Contract manufacturers that were capacity-constrained for the branded product may reallocate to higher-margin products post-exclusivity.

What generic or authorized generic entry risks affect ZIPSOR supply planning?

Featured snippet answer: Entry risks are linked to Orange Book patent challenges (including Paragraph IV) and any settlement-driven timing that affects whether branded supply faces immediate competitive substitution.

Key litigation and settlement drivers

• Paragraph IV certifications for diclofenac potassium products
• Settlement agreements that delay or expedite launches
• “Skinny label” or substitution pathways for NSAID dosing forms

How does ZIPSOR compare to other diclofenac potassium products by supplier footprint?

Featured snippet answer: For diclofenac potassium, supplier footprints typically differ by dosage form (immediate-release vs other formulations) and by whether the product is branded or generic.

Comparison dimensions

• Manufacturer/packager names on labeling
• NDA vs ANDA supply chains
• Tablet strength presentation and packaging format

What formulation and manufacturing IP can constrain substitute supply for ZIPSOR?

Featured snippet answer: For ZIPSOR, supply substitution is most constrained by product-specific patents (formulation, process, and method-of-use) and the ability to meet FDA requirements for bioequivalence and manufacturing controls.

Manufacturing barriers that matter commercially

• Process patents affecting API conversion or crystallization steps (if claimed)
• Tablet formulation patents impacting excipient composition or dissolution characteristics
• Method-of-use patents for dosing regimens, if still in force

Key Takeaways

• ZIPSOR’s practical “supplier” in the U.S. is the drug product manufacturer listed on the prescribing information and carton labeling.
• Orange Book data supports patent and exclusivity mapping but does not provide a complete supplier list by itself.
• Supplier networks can shift due to contract manufacturing, site remediation, and market-competition timing tied to exclusivity and patent expiry.
• For procurement, pricing, and litigation readiness, the critical step is label-to-facility mapping for finished dosage manufacture, then aligning it with FDA establishment and inspection records.

FAQs

1. How can I confirm who manufactures ZIPSOR tablets?
   Use the “Manufactured by” and “Packaged by” entries on the ZIPSOR prescribing information and carton labeling, then map the named site to FDA facility records.

2. Does ZIPSOR have different suppliers for API and finished dosage form?
   Diclofenac API sourcing and finished-dose manufacturing are often split in small-molecule supply chains; label manufacturer fields identify the finished product source.

3. Do supplier identities change during the life of ZIPSOR?
   Contract manufacturing and packaging arrangements can change across label revisions even if the brand labeler stays constant.

4. How do patent challenges or Paragraph IV filings affect ZIPSOR’s supplier strategy?
   They affect expected brand vs generic competition timelines, which influences capacity planning and whether alternate sites or suppliers are added.

5. What data sources best support ZIPSOR supplier due diligence?
   ZIPSOR labeling (prescribing information and carton labeling) plus FDA application-level mappings (Orange Book) and facility/inspection records provide the most actionable supplier evidence.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. Food and Drug Administration. Drug Labeling (DailyMed) for ZIPSOR (diclofenac potassium).
3. U.S. Food and Drug Administration. FDA Establishment Registration and Drug Listing / facility-related public records (for mapping manufacturer names to sites).