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Suppliers and packagers for INDOCIN
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INDOCIN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Zyla | INDOCIN | indomethacin | SUSPENSION;ORAL | 018332 | NDA | Zyla Life Sciences US LLC | 69344-101-01 | 1 BOTTLE, GLASS in 1 CARTON (69344-101-01) / 237 mL in 1 BOTTLE, GLASS | 2019-02-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for INDOCIN
INDOCIN (indomethacin) suppliers: who manufactures the drug and API across US and global markets
Executive summary: INDOCIN is indomethacin. In the US, the brand is marketed under Pfizer (INDOCIN Capsules and related presentations). The indomethacin API is supplied by multiple global chemical manufacturers, and generic entrants source from several contract manufacturers and API plants. The exact supplier mix varies by strength, dosage form, and packaging configuration, but the commercial supply chain is concentrated in a small set of indomethacin API producers plus downstream solid oral dosage manufacturers under contract and for multiple labelers.
Which companies supply INDOCIN (indomethacin) in the US?
Answer: The branded product “INDOCIN” is marketed in the US by Pfizer for indomethacin oral capsules. Generic INDOCIN equivalents are marketed by multiple companies under abbreviated applications, each sourcing formulation and packaging through its own supply chain (often contract manufacturers) and sourcing indomethacin API from one or more global chemical suppliers.
What does “supplier” mean for INDOCIN?
For pharmaceutical procurement and IP risk work, “supplier” typically breaks into three layers:
- Labeler/market authorization holder (who sells the marketed product in-market)
- Dosage-form manufacturer (who makes and packages tablets/capsules)
- API manufacturer (who makes indomethacin active ingredient)
INDOCIN procurement decisions can involve all three.
What API suppliers make indomethacin (the drug substance) that feed INDOCIN and generics?
Answer: Indomethacin API is made by multiple chemical manufacturers globally. The indomethacin market has multiple commercial producers because the molecule is off-patent in many jurisdictions and supports a deep generic supply base.
API supply chain characteristics
- Commercial indomethacin is produced in bulk by specialty chemical firms.
- Downstream manufacturers buy API and formulate solid oral dosage forms (capsules in the INDOCIN lineage).
- API supply is often diversified across plants and regions to manage regulatory and continuity risks.
How to identify actual indomethacin API suppliers for a specific NDC
For a given NDC (strength and package configuration), the most direct supplier identification comes from:
- FDA Drug Master Files (DMFs) tied to the product’s NDA/ANDA,
- Orange Book linked submissions and labeler history,
- and the current manufacturing site listed on FDA labeling for the dosage form.
Without mapping a specific INDOCIN NDC and strength, the supplier list cannot be made complete at the “named company” level with audit-grade precision.
What manufacturers make INDOCIN capsules (formulation and packaging suppliers)?
Answer: INDOCIN is a solid oral dosage. The dosage-form manufacturing and packaging are performed by contract and in-house manufacturing sites used by the labeler. For US branded INDOCIN, the manufacturer list is reflected on the US label and the submission manufacturing sections.
Why dosage-form suppliers differ by strength
Procurement and filings often split supply by:
- capsule size,
- excipient composition,
- packaging formats (bottles vs unit dose),
- and distribution regions.
That creates different manufacturing plants tied to different product codes even when the labeler is the same.
Which generics compete with INDOCIN, and who supplies them?
Answer: Multiple generic indomethacin capsule products compete in the US. Each generic labeler maintains its own sourcing of API and its own contract manufacturing/packaging arrangements, so “the supplier” is not one company across the class.
What matters for supplier selection
- Ability to supply the correct strength and capsule formulation
- FDA compliance history (inspection outcomes)
- DMF linkage for API
- Continuity of API supply for indomethacin (multi-source capability)
- Packaging and labeling compliance for the target NDC
How many supplier options exist for indomethacin (INDOCIN) in the US market?
Answer: Supplier options are plural because indomethacin is widely available as generics and because multiple manufacturers can source the same chemical API commodity. The count depends on:
- the exact INDOCIN strength and dosage form,
- the NDC list currently marketed,
- and whether you count API DMF holders versus finished dosage labelers and manufacturers.
What is the Orange Book status of INDOCIN (indomethacin) and how does it affect suppliers?
Answer: INDOCIN (indomethacin) is an established, off-patent small-molecule product in most major jurisdictions. Patent exclusivity and remaining listed exclusivities, if any, typically do not restrict most suppliers for long-term indomethacin availability. That contributes to a broad generic supply base.
Supplier impact of off-patent status
- Low barriers to entry for many applicants.
- Multiple API sources support redundancy.
- Competition shifts to manufacturing quality and supply continuity rather than market authorization exclusivity.
When does INDOCIN lose exclusivity or where are patent/Paragraph IV challenges relevant?
Answer: For indomethacin, ongoing supplier diversification indicates limited remaining exclusivity constraints. Paragraph IV challenges are typically relevant to active patent protection for specific formulations or methods of use, not to the base molecule at this stage for most markets.
Practical procurement implication
For most INDOCIN procurement needs, continuity and regulatory status of the chosen NDC and manufacturing site matter more than patent clearance in US commercial supply, given the mature market structure.
What FDA regulatory pathway differences affect “supplier” identification for INDOCIN generics?
Answer: Indomethacin generics typically use ANDA pathways. The supplier identity becomes visible via:
- drug substance DMF references for API,
- ANDA manufacturing site listings for dosage forms,
- and labeling for the finished product.
Which regions have the largest indomethacin API and finished dosage manufacturing capacity?
Answer: Indomethacin API and capsule manufacturing capacity are concentrated in global generic and chemical manufacturing hubs. The exact “top suppliers” change with inspections, DMF approvals, and supply contracts, but the multi-source nature of indomethacin generally supports at least two independent supply chains for most downstream manufacturers.
INDOCIN supplier due diligence checklist (for sourcing and IP/regulatory risk)
Use this to qualify supplier candidates for indomethacin capsules:
- Match the exact NDC (strength, capsule size, and packaging configuration)
- Verify finished dosage manufacturer sites on FDA labeling
- Confirm API DMF linkage (API supplier and site)
- Review GMP inspection outcomes for both API and dosage-form sites
- Confirm stability data and shelf-life compliance for the specific formulation
- Validate quality agreements for change control (API swaps, site changes)
- Check for deviations, recalls, and OOS/OOT trends on prior lots
- Ensure cold chain not required (for indomethacin oral solids, typically not)
Key Takeaways
- INDOCIN is indomethacin. In the US, Pfizer is the branded labeler for INDOCIN oral capsules.
- The supply chain is multi-tier: branded labeler, dosage-form manufacturer/packager, and indomethacin API chemical producers.
- Because indomethacin is off-patent and widely generified, supplier availability is broad, with procurement mainly constrained by NDC-level manufacturing sites and API DMF supply continuity rather than exclusivity.
- Supplier identity must be tied to the exact NDC and strength using FDA-linked manufacturing and DMF references.
FAQs
1) Who is the manufacturer for INDOCIN capsules in the US?
The US branded product is marketed by Pfizer, while dosage-form manufacturing is handled by labeled manufacturing sites shown on the product’s US labeling and submission details for the specific NDC.
2) Are there multiple indomethacin API suppliers available for generic manufacturers?
Yes. Indomethacin is supplied by multiple API producers globally to support the many generic indomethacin labelers in the market.
3) How do I identify the indomethacin API supplier for a specific generic NDC?
Map the NDC to its ANDA entry and then check the FDA submission for the referenced drug substance DMF and manufacturing site list for the dosage-form manufacturer.
4) Does INDOCIN have long exclusivity that limits suppliers?
The INDOCIN indomethacin molecule is mature and broadly available. Supplier competition is driven by manufacturing and supply continuity more than by exclusivity constraints.
5) What supply risks matter most for indomethacin capsule sourcing?
API continuity, change control (API/site swaps), and finished dosage GMP performance are the primary operational risks.
References (APA)
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
- U.S. Food and Drug Administration. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
- U.S. Food and Drug Administration. Drug Master Files (DMF). https://www.fda.gov/drugs/guidance-documents-drugs/drug-master-files-dmf
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