sulindac: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Epic Pharma	SULINDAC	sulindac	TABLET;ORAL	072711	ANDA	PuraCap Laboratories LLC dba Blu Pharmaceuticals	24658-771-01	100 TABLET in 1 BOTTLE (24658-771-01)	2016-11-14
Epic Pharma	SULINDAC	sulindac	TABLET;ORAL	072711	ANDA	PuraCap Laboratories LLC dba Blu Pharmaceuticals	24658-771-05	500 TABLET in 1 BOTTLE (24658-771-05)	2016-11-14
Epic Pharma	SULINDAC	sulindac	TABLET;ORAL	072711	ANDA	Epic Pharma, LLC	42806-011-01	100 TABLET in 1 BOTTLE (42806-011-01)	2010-01-25
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 23, 2026

Suppliers for Sulindac (APIs, Dosage Forms, and Contract Manufacturing)

Sulindac supply chains typically split into (1) generic API production, (2) finished-dose manufacturing for tablets, and (3) packaging and distribution through wholesale pharmaceutical networks. Market availability is dominated by multiple interchangeable generic manufacturers in tablets and by contract manufacturing for value-added steps (blistering, bottling, labeling, and country-level distribution).

What follows is a supplier map by role and product category for sulindac supply risk assessment: API sourcing, finished dosage makers, and known channel/wholesale distributors.

Which companies supply the sulindac API for generic production?

Sulindac is widely supplied as an API for generic tablet manufacturers. The practical “supplier list” for API is best represented as (a) API manufacturers/marketers supporting ANDA production and (b) distributors that hold supply rights for finished doses.

API supply characteristics

Mostly generic-focused supply, with multiple qualified sources.
API and intermediates are frequently sourced from different countries, then finished as tablets in regional markets.
Regulatory linkage flows through ANDAs and current Good Manufacturing Practice (cGMP) sites listed for drug product manufacturing.

API sourcing patterns to evaluate

API-only supply vs. full CMO package: Some suppliers provide API only; others support the full drug product manufacturing chain.
Intermediate supply: Sulindac API supply often depends on upstream intermediates; disruption risk is upstream.
Batch release and testing: Finished drug supply hinges on validated analytical methods, impurity profiles, and stability programs.

Who makes generic sulindac tablets in the US and where are the manufacturing sites?

Generic sulindac tablets are typically produced by multiple US and international manufacturers using different NDA/ANDA holders and cGMP sites. In the US, the authoritative mapping of “who makes what” is the Orange Book linkage between:

ANDA applicant/holder, and
listed drug strength, dosage form, and
manufacturing location(s).

How to structure sulindac supplier due diligence

Identify the Orange Book listed drug entries for each strength (typically 150 mg).
Match each strength to the ANDA applicant and its manufacturing site(s).
Validate whether supply is direct from applicant or via contract packaging/distribution.

(A complete, site-level supplier list requires Orange Book entry extraction for each sulindac dosage strength.)

What suppliers support sulindac distribution and wholesaling in the US?

Sulindac finished doses are generally distributed through the major wholesale pharmaceutical distribution networks. These distributors do not manufacture the drug product, but they control pipeline availability, inventory depth, and tender/contract supply.

Typical US wholesale distribution roles

National wholesalers (distribution, warehousing, secondary logistics)
Specialty distribution channels for certain NDC/packaging presentations
Repackagers and relabelers for contracted markets (when allowed)

Wholesale network due diligence

Confirm whether suppliers use GPO/contract channels that constrain access during shortages.
Track whether NDCs are sold via exclusive distribution or multiple channels.
Verify cold-chain handling is not required (typical sulindac tablet distribution is standard ambient logistics).

How do contract manufacturers (CMOs) participate in sulindac tablet supply?

For older, off-patent oral small molecules like sulindac, CMOs commonly participate in:

tablet compression and coating,
blending and granulation,
packaging and labeling,
stability testing support for marketed strengths.

CMT/CMO technical responsibilities to confirm

Supplier can meet tablet hardness, dissolution, and impurity specifications.
Scale-up robustness and continued process verification (where applicable).
Analytical method transfer capability for release and stability.

What formulation and packaging suppliers matter for sulindac tablets?

Sulindac is commonly marketed as oral tablets. Supplier risk concentrates in:

tablet-formulation process controls,
packaging formats and labeling,
line clearance and cross-contamination prevention.

Packaging supplier touchpoints

Bottling versus blister packaging availability for specific NDCs
Labeling language compliance by market and distribution channel
Tamper-evident packaging requirements where applicable

Which upstream raw material suppliers affect sulindac API continuity?

API continuity risk often sits with upstream suppliers of:

sulindac key intermediates,
critical reagents for synthesis,
solvent and catalyst supply for impurity control.

Upstream risk indicators

Limited number of qualified sources for a critical intermediate
Tight impurity specifications that require specific upstream purity profiles
Seasonal or regional production constraints

Orange Book status: which sulindac products are supplied under which ANDAs?

Orange Book is the controlling index for generic sulindac listing. A complete mapping requires extraction of:

listed drug name,
strength,
dosage form,
applicant/holder,
patent and exclusivity codes (if any),
and listed manufacturing sites.

Why this matters for suppliers

Two ANDA products can share the same strength but rely on different manufacturing sites.
If one site is down, substitution depends on NDC-level equivalence and supply availability.

What patent or litigation constraints change sulindac supplier availability?

For sulindac, many products are off exclusivity, but supply can still be constrained by:

site-specific manufacturing restrictions,
product-specific consent decrees,
ongoing regulatory actions affecting specific ANDAs/NDCs.

Supplier impact categories

“Operational delay” from consent decree remediation at a manufacturing site
“Regulatory hold” or narrowed distribution if quality issues persist
Temporary suspension if warning letters trigger batch disposition restrictions

Generic entry risks: what could cause sulindac supply disruptions by supplier?

Key disruptions include:

manufacturing site capacity constraints,
delayed stability program transfers,
validated method transfer failures,
raw material impurity excursions causing lot rejection,
packaging line changeover delays.

Business impact

Distributor lead times increase, pushing substitutions across NDCs.
Price volatility appears first at NDC level, then across strengths.

How does sulindac compare with other NSAIDs in supplier concentration and availability?

Sulindac’s supplier landscape is typical of older NSAIDs: multiple generic tablet sources, but a small number of cGMP sites can dominate short-term availability during disruptions.

Comparison lens

Newer NSAIDs often have more active regulatory and life-cycle patent activity.
Older products like sulindac tend to have broader ANDA coverage but still concentrate manufacturing capacity at fewer sites for each NDC presentation.

Key Takeaways

Sulindac supply is dominated by generic tablet manufacturing under ANDAs, with API sourced from multiple cGMP suppliers and distributed through major wholesale networks.
The highest-value supplier intel is Orange Book-linked: ANDA holder to manufacturing site mapping by strength and NDC presentation.
Supply disruption risk concentrates upstream (key intermediates and impurity-sensitive reagents) and downstream (tablet packaging and labeling line capacity).
Patent or litigation constraints are less about drug molecule exclusivity in the abstract and more about site-specific regulatory/quality status that can reduce sellable supply.

FAQs

1) How can I identify the exact manufacturer for a specific sulindac NDC?
Use the NDC-to-ANDA crosswalk via the Orange Book entry for the listed strength and dosage form, then match the applicant to the listed manufacturing site(s).

2) Do sulindac tablets require special storage conditions from suppliers?
Sulindac is typically distributed under standard ambient warehouse conditions for oral solid dosage forms; confirm on the product label and stability/storage section of the approved labeling.

3) What is the biggest driver of sulindac lot shortages: API or packaging?
Both can drive shortages, but oral solid manufacturing bottlenecks often emerge at packaging and tablet compression lines, while API excursions emerge from impurity or intermediate supply constraints.

4) Can a distributor supply sulindac from multiple sources under the same strength?
Yes at the channel level, because multiple NDCs can exist for the same strength. Supply continuity depends on which specific NDCs are carried under contracts.

5) What cGMP requirements should sulindac tablet suppliers demonstrate?
They must meet tablet release specifications (dissolution, impurities, assay), stability obligations, and validated manufacturing controls for cross-contamination prevention.

References

No specific sources were cited because no supplier list, Orange Book extraction, or manufacturer/ANDA data were provided in the prompt.

Suppliers and packagers for sulindac

sulindac