Suppliers and packagers for NESINA

NESINA

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	NESINA	alogliptin benzoate	TABLET;ORAL	022271	NDA AUTHORIZED GENERIC	Padagis Israel Pharmaceuticals Ltd	45802-087-65	30 TABLET, FILM COATED in 1 BOTTLE (45802-087-65)	2016-04-08
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271	NDA AUTHORIZED GENERIC	Padagis Israel Pharmaceuticals Ltd	45802-103-65	30 TABLET, FILM COATED in 1 BOTTLE (45802-103-65)	2016-04-08
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271	NDA AUTHORIZED GENERIC	Padagis Israel Pharmaceuticals Ltd	45802-150-65	30 TABLET, FILM COATED in 1 BOTTLE (45802-150-65)	2016-04-08
Takeda Pharms Usa	NESINA	alogliptin benzoate	TABLET;ORAL	022271	NDA AUTHORIZED GENERIC	A-S Medication Solutions	50090-5574-0	30 TABLET, FILM COATED in 1 BOTTLE (50090-5574-0)	2016-04-08

Nesina (Alogliptin) Suppliers: Who Manufactures, Supplies, and Sources the Drug Product and Key Intermediates

Last updated: May 26, 2026

Nesina is the brand name of alogliptin (DPP-4 inhibitor) marketed by Takeda. The supply chain for Nesina is split between (1) active pharmaceutical ingredient (API) and key intermediates and (2) finished-dose drug product (tablets), with additional complexity from contract manufacturing and co-marketing arrangements across markets. This page maps who supplies the drug in practice, where they show up in regulatory filings and commercial contracting, and what roles they typically play.

Who supplies Nesina (alogliptin) tablets in the US and EU?

Answer: Nesina tablets are marketed in the US by Takeda, with drug product manufacturing typically performed under contract manufacturing relationships that feed Takeda’s commercial supply. API supply is sourced via specialized API and intermediate manufacturers that support alogliptin production through established chemical routes.

What is the typical Nesina supply structure?

• Commercial brand holder: Takeda (holds label responsibility and US commercialization; also drives supply planning).
• Drug product manufacturer(s): Contract manufacturing and packaging sites listed in regulatory submissions and manufacturing disclosures.
• API and intermediate supplier(s): Specialized chemical manufacturers supplying alogliptin API and upstream intermediates, often by long-term supply agreements.

How to identify Nesina suppliers in regulatory records?

Market participants typically identify “suppliers” by cross-referencing:

• FDA drug product and site manufacturing disclosures (label and regulatory modules)
• API manufacturing sites (DMF-linked or API site listings, where disclosed)
• Foreign regulatory dossiers (EMA/NCAs where manufacturing sites are disclosed)
• Distribution networks (commercial availability and wholesaler sourcing patterns)

What companies supply alogliptin API for Nesina?

Answer: Alogliptin API is supplied by chemical manufacturers with capabilities in DPP-4 inhibitor chemistry. In practice, the same firms that supply alogliptin API into global markets often support brand and generic production through API and intermediate manufacturing agreements.

API supplier archetypes for alogliptin

• Dedicated API manufacturers that operate cGMP API plants and have controlled polymorph and impurity profiles for DPP-4 inhibitors.
• Multi-product fine-chemical companies providing key intermediates and then selling API through a finishing step.
• DMF-connected suppliers where manufacturing site identity is tied to the DMF relationship (where publicly traceable).

API supplier identification in litigation and generic filings

In Paragraph IV and ANDA ecosystems, generic applicants typically list:

• API source/manufacturer in ANDA Chemistry, Manufacturing, and Controls sections
• DMF references that reveal API manufacturing relationships
  These disclosures are frequently mirrored in later litigation documents that name supplier entities.

What contract manufacturers make Nesina tablets?

Answer: Nesina tablets are typically produced by contract manufacturing organizations (CMOs) under Takeda direction. The contract manufacturer is responsible for:

• tableting, coating, and packaging
• in-process controls for uniformity and dissolution
• stability program management and batch release testing support

Common tablet manufacturing supply components

• Blend and tablet press capabilities aligned with alogliptin dosing
• Coating and finishing steps that preserve stability
• Lot disposition and packaging into commercial bottles/blisters

How finished-dose CMO identity is confirmed

• Through FDA label “Manufactured for” language and site-specific manufacturing statements
• Through registration listings and supplements where site transfers occur
• Through quality agreements referenced in dispute resolution and litigation (when they surface)

Which suppliers support Nesina manufacturing of solids, blistering, and packaging?

Answer: Tablet packaging is frequently handled by separate entities from API and primary tablet manufacturing, with some suppliers providing:

• bottling and secondary packaging
• blister packaging (foil/film systems)
• cold-chain is generally not applicable for alogliptin tablets, so ambient packaging capability is the norm

Typical packaging supply categories

• Primary packaging supplier (bottles, caps, desiccants if applicable)
• Blister pack supplier (where used)
• Finished goods warehousing and distribution partners (logistics firms)

Which alogliptin intermediates are usually sourced by suppliers?

Answer: Suppliers supporting alogliptin manufacture generally cover critical intermediates used to build the core heterocycle and then close the final functional groups. In supply chain terms, these suppliers fall into two tiers:

1. intermediate chemistry suppliers producing key building blocks
2. API finishing suppliers that complete purification and meet regulatory impurity specifications

Why intermediate sourcing matters for availability

• intermediate shortages constrain API batch release
• impurity profile shifts can force changes in purification steps
• site-specific impurities and residual solvents drive qualification burdens

What generic and biosimilar supply risks affect Nesina suppliers?

Answer: While Nesina is a small molecule with generics rather than biosimilars, generic supply entry can still pressure the branded supply chain through:

• increased competition for API capacity
• supplier reallocation toward higher volume contracts
• price compression that can lead to supplier renegotiation or site transfers

Paragraph IV and ANDA dynamics that influence supply

Generic applicants may:

• secure API supply contracts that compete with branded demand
• drive supplier discounting and re-prioritization
• seek alternative intermediates or API manufacturers, impacting who runs later cycles

What is the Orange Book status of Nesina and how does it relate to suppliers?

Answer: Orange Book listings determine which patents and exclusivity periods constrain ANDA entry; supplier capability and contract terms determine who can scale quickly when entry becomes available.

Why supplier mapping ties to Orange Book milestones

• API and tablet manufacturing capacity are the rate-limiting steps at launch
• site changeovers can trigger batch release delays
• patent-expiry timelines drive demand planning among API and CMO suppliers

Who challenges Nesina with ANDAs and how does that impact supplier allocation?

Answer: Generic challenges to alogliptin-based brands can re-route API capacity and manufacturing schedules, particularly around major patent cliffs and exclusivity expirations.

Typical impact channels

• API price pressure
• re-qualification of alternative sites
• increased demand for packaging and finished-dose inventory near launch windows

Nesina supplier map: what to check for in actual contract and regulatory documents

Actionable diligence checklist (supplier discovery):

• Takeda’s product label “manufactured for” and “distributed by” statements for finished-dose site identifiers.
• FDA establishment registration and product listings for drug product and manufacturing sites.
• DMF-linked references in ANDA filings that reveal API supplier identities.
• Litigation exhibits (complaints, motions, and discovery) naming API/CMO entities.

Key Takeaways

• Nesina (alogliptin) supply is split between Takeda as brand holder and contract manufacturers for drug product, with API/intermediate suppliers covering upstream chemical manufacturing.
• “Supplier” can mean different roles: API manufacturer, CMO tablet/packager, packaging supplier, and distribution/logistics partner.
• The fastest way to map real suppliers is to triangulate FDA manufacturing site disclosures, DMF-linked API references, and litigation or ANDA documents that name production entities.
• Generic entry and patent timelines can shift API capacity allocation, affecting availability and pricing across the supply chain.

FAQs

1. How do I find Nesina tablet manufacturers listed on the FDA label and packaging sites?
2. Which alogliptin API DMFs are commonly referenced by generic applicants for ANDAs?
3. What manufacturing sites matter most for batch release of alogliptin tablets (API vs drug product)?
4. How do patent expirations for alogliptin brands influence API and CMO supplier demand?
5. What evidence from ANDA filings most reliably identifies the actual API supplier for alogliptin?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book).
2. FDA. Drug Establishment Registration and Drug Listing (DERP/DUR) and related manufacturing site information.
3. FDA. Application and drug submission databases for ANDA/DMF-linked manufacturing disclosures.