Suppliers and packagers for ACTOS

ACTOS

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073	NDA	Takeda Pharmaceuticals America, Inc.	64764-151-02	6 CARTON in 1 TRAY (64764-151-02) / 1 BLISTER PACK in 1 CARTON / 7 TABLET in 1 BLISTER PACK	1999-07-15
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073	NDA	Takeda Pharmaceuticals America, Inc.	64764-151-04	30 TABLET in 1 BOTTLE (64764-151-04)	1999-07-15
Takeda Pharms Usa	ACTOS	pioglitazone hydrochloride	TABLET;ORAL	021073	NDA	Takeda Pharmaceuticals America, Inc.	64764-151-05	90 TABLET in 1 BOTTLE (64764-151-05)	1999-07-15

Actos (pioglitazone) Suppliers: API, Finished-Dose Manufacturers, and Contract Manufacturing Landscape

Last updated: May 24, 2026

Actos is a branded, oral thiazolidinedione built on pioglitazone hydrochloride. At a supplier level, the market splits into (1) pioglitazone API manufacturers, (2) contract manufacturers and finished-dose packagers for tablets, and (3) logistics and secondary packaging suppliers tied to specific NDC labelers. Without a specific NDC strength (e.g., 15 mg, 30 mg, 45 mg) and labeler, a complete supplier map cannot be stated accurately.

What companies supply pioglitazone API for Actos?

Featured snippet answer: The pioglitazone API supply chain is international and typically includes specialized API producers with DMF filings that support generic and branded finished-dose tablets, but Actos-specific API suppliers must be tied to specific DMFs and the finished-dose labeler for the relevant NDC.

Common API supply dynamics for pioglitazone hydrochloride

• API is commonly supplied via DMF-linked routes (Type II and/or Type III) used by multiple tablet manufacturers.
• Finished-dose tablet makers contract for API supply and tablet manufacture, then package under a labeler (NDC) responsible for FDA listing.

Why Actos API suppliers vary by NDC

Actos tablets are marketed under specific NDCs tied to manufacturing sites and labelers. If the same labeler uses multiple contract manufacturing sites across strengths or label refresh cycles, API sourcing can shift.

Which manufacturers make Actos tablets (15 mg, 30 mg, 45 mg) for the U.S. market?

Featured snippet answer: The finished-dose manufacturer for Actos depends on the NDC and strength. A definitive “who makes Actos tablets” list requires NDC-level Orange Book and FDA facility linkage.

What defines an “Actos tablet manufacturer” in the regulatory record

• FDA facility listing: the site associated with the product’s manufacturing/packaging steps.
• NDC labeler: the firm responsible for the listing, which may outsource to one or more contract manufacturers.
• Orange Book entries: if listed, they can point to specific NDA holder and some manufacturing details, but NDC-level mapping is still required.

Finished-dose outsourcing is typical for branded tablets

For older, off-patent oral small molecules, branded products often use contract manufacturing for batch execution and packaging, with internal quality systems and release testing under the labeler.

How do Actos supply contracts work: API sourcing vs tablet CDMO?

Featured snippet answer: Supply contracts for pioglitazone tablets typically allocate API supply risk to DMF-linked API vendors and allocate batch manufacturing and packaging risk to CDMOs under QMS-controlled transfer and validated manufacturing methods.

Typical contract split

• API: DMF-based qualification, impurity and polymorph controls, and change-management clauses.
• Tablets: formulation blend controls, compression parameters, dissolution specs, and stability commitments.
• Packaging: bottle, blister, label printing, lot traceability, and serialization where applicable.

Regulatory glue: controlled changes and site qualification

Even for an established product, switching API lots, grades, or manufacturing sites triggers comparability and change control. CDMO/site switches also require validation, stability updates, and batch record controls.

What FDA filings indicate pioglitazone API and tablet manufacturing suppliers?

Featured snippet answer: FDA DMFs and NDA/ANDA manufacturing facility listings are the main artifacts that connect suppliers to the regulatory record.

DMF pathway for API suppliers

• API makers file DMFs describing manufacturing and controls.
• Finished-dose manufacturers reference those DMFs to support API supply.

FDA facility listing and site mapping

• FDA’s drug establishment listing connects the labeler and manufacturing activities to specific facilities.
• For a complete supplier roster, each Actos NDC must be mapped to its manufacturing/packaging facilities.

What Orange Book status does Actos have, and does that change supplier options?

Featured snippet answer: Actos contains Orange Book–listed patents in the past, but Actos’s current supplier set is driven less by exclusivity and more by labeler, manufacturing site availability, and commercial supply continuity.

Patent and exclusivity do not fully determine supply

Even if patents do not restrict generic entry for pioglitazone itself, branded supply can still be concentrated with a limited number of experienced tablet CDMOs and established API suppliers.

What to expect for older small molecules

• API supply is more diversified.
• Tablet manufacturing often stays with a small set of CDMOs that can meet long-term stability and demand.

Which generic and alternative pioglitazone manufacturers overlap with Actos supply chains?

Featured snippet answer: Many companies supply pioglitazone tablets generically, and those firms’ manufacturing activities can overlap with the same CDMOs used by branded tablet makers, but overlap must be proven via NDC-to-facility mapping.

Overlap patterns

• Shared CDMOs across multiple labelers.
• Shared API DMF referencing among multiple tablet manufacturers.

Competitive landscape implication for “Actos suppliers”

For sourcing, the practical supplier shortlist often includes:

• API vendors with multiple DMF references.
• CDMOs that already run pioglitazone tablet compression and coating steps for several labelers.

When does Actos tablet supply risk spike: shortages, plant outages, or API changes?

Featured snippet answer: Supply risk spikes when API production is concentrated, a key CDMO line has downtime, or when regulatory holds are triggered by deviations or failing stability runs.

Key operational failure points

• API batch rejections due to impurity excursions.
• Tablet manufacturing deviations affecting uniformity, hardness, or dissolution.
• Packaging line disruptions affecting lot distribution.

Supplier redundancy and qualification cadence

Brands typically hold qualified alternate suppliers, but the availability varies by strength and packaging configuration.

Key supplier categories for sourcing Actos (actionable structure)

Featured snippet answer: For procurement and diligence, structure suppliers into three tiers: (1) pioglitazone API producers, (2) tablet CDMOs for compression and coating, and (3) packaging/labeling facilities aligned to specific Actos NDCs.

Tier 1: Pioglitazone API suppliers

• DMF-linked API manufacturers for pioglitazone hydrochloride
• Contract API repackagers are less common than primary API makers, but distribution intermediaries may exist

Tier 2: Finished-dose manufacturers (tablets)

• Tablet compression and coating CDMOs
• Site-specific controls on dissolution and impurities

Tier 3: Packaging and distribution

• Bottle/blister packaging lines
• Label printing and carton coding
• Warehouse and cold-chain are typically not relevant for pioglitazone tablets, but chain-of-custody is

What is the practical next step to build a supplier list for Actos?

A complete, accurate supplier list must be NDC-specific and trace each strength to: labeler, manufacturing facility, and associated API DMF references. Without NDC and strength, any named supplier set would be incomplete or potentially wrong.

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Key Takeaways

• “Actos suppliers” must be defined at NDC level: API source, tablet CDMO site, and packaging labeler can vary by strength and over time.
• Regulatory linkage runs through FDA drug establishment listings (facilities) and DMFs (API manufacturers), with Orange Book helping only indirectly.
• Supplier risk is operational: API excursions, CDMO line downtime, and packaging disruptions drive shortages more than patent status.

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FAQs

1. Who makes pioglitazone tablets in the U.S. (contract manufacturers) and how can I verify it?
2. Which DMFs cover pioglitazone hydrochloride API used for branded and generic tablets?
3. Do Actos 15 mg and 45 mg use the same manufacturing facility and packaging suppliers?
4. How do FDA drug establishment listings map to NDC labelers for Actos?
5. What indicators in FDA data suggest a supply disruption for pioglitazone tablets?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. Food and Drug Administration. Drugs@FDA.
3. U.S. Food and Drug Administration. Drug Establishment Registration and Listing (DERL).