Suppliers and packagers for generic pharmaceutical drug: Ubrogepant

Ubrogepant

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765	NDA	Allergan, Inc.	0023-6498-01	1 PACKET in 1 BOX (0023-6498-01) / 1 TABLET in 1 PACKET	2019-12-23
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765	NDA	Allergan, Inc.	0023-6498-04	4 PACKET in 1 BOX (0023-6498-04) / 1 TABLET in 1 PACKET	2019-12-23
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765	NDA	Allergan, Inc.	0023-6498-10	10 PACKET in 1 BOX (0023-6498-10) / 1 TABLET in 1 PACKET (0023-6498-02)	2019-12-23

Suppliers and packagers for generic pharmaceutical drug: Ubrogepant

Last updated: May 25, 2026

Ubrogepant suppliers: API, finished dose, and key upstream manufacturing for Ubrelvy (ubrogepant)

Ubrogepant is marketed in the US as Ubrelvy (oral tablets). The drug’s supply chain splits into (1) active pharmaceutical ingredient (API) manufacture, (2) tablet formulation and dose-filling, and (3) packaging and distribution into US retail channels. Public procurement, CMO announcements, and regulatory filings typically identify a limited set of upstream manufacturers, while many “suppliers” for the branded product are represented contractually by the marketing authorization holder and distribution partners.

Core callout for business planning: ubrogepant finished dose supply is concentrated through one or a small number of contract manufacturers for film-coated tablets. API supply likewise typically centers on a small set of specialty chemical sites capable of late-stage intermediates, final API purification, and validated solid-state controls. For procurement and litigation risk mapping, the actionable supplier set is the manufacturer(s) listed on FDA documents and in the product’s supply chain records used for commercial manufacture and label distribution.

No supplier list can be produced from this prompt alone. A complete, accurate supplier roster requires specific source documents (FDA labeling/manufacturer sections, Drug Master File listings, Orange Book manufacturer and NDC firm identifiers, procurement awards, or company disclosures). Without those, any named “suppliers” would be incomplete or potentially wrong.

Which companies supply ubrogepant API and finished tablets in the US?

Suppliers fall into two categories for commercialization and inventory planning:

• API suppliers (ubrogepant bulk drug substance): chemical manufacturing sites producing ubrogepant with validated polymorph control, solvent residual limits, impurity profile controls, and stability-defined retest/shelf-life.
• Drug product suppliers (ubrogepant tablets): GMP facilities producing film-coated tablets, with blending, granulation or direct compression, coating, and packaging under validated stability and cGMP change control.

What to verify in supplier diligence

• FDA label “Manufactured for” / “Manufactured by” or “Distributed by” firms.
• Orange Book listing “Applicant” and “Manufacturer” entries (when present by firm for the NDA).
• NDC directory entries and “Labeler”/“Manufacturer” relationships for each strength and dosage form.
• DMF-holder information for the drug substance (when publicly indexed).
• Recent FDA batch/manufacturing inspection outcomes tied to the labeled manufacturing sites.

What does the Orange Book listing for ubrogepant show about manufacturers?

For a branded small-molecule drug like ubrogepant, Orange Book content is typically used to identify:

• NDA applicant/holder
• dosage form
• patents and exclusivity
• in some cases, related manufacturers and listed drug details

Business use

• Cross-map the Orange Book “listed drug” firm(s) to NDC labelers and to the commercial packaging/manufacturing sites shown on label and in NDC records.
• Use the firm names as the anchor set for supplier onboarding, quality agreements, and serialization compatibility.

Where can ubrogepant suppliers be identified from the FDA drug label?

The FDA package insert and prescribing information identify key commercial actors in a way that procurement teams can act on:

• Manufacturing/packaging statements (who actually made the tablets and where)
• Marketing authorization holder (who is responsible for the NDA)
• Distributor (often separate from manufacturer)

Why it matters

• Label/manufacturing language is the most direct mapping to the facility that releases batches for market distribution.
• It also supports regulatory risk tracking for inspection outcomes and potential supply disruptions.

How many ubrogepant drug product manufacturing sites supply the US market?

The practical answer for high-volume oral solids often includes:

• 1 primary site for scale manufacture
• 1 backup/secondary site for resilience
• One or more packaging facilities for secondary labeling and distribution readiness

What changes

• Strength-by-strength manufacturing can shift over time due to capacity, change control, or new CMO contracts.
• Supplier churn increases around patent challenge periods, supply chain re-allocations, or equipment upgrades.

Which CMOs make ubrogepant tablets (film-coated oral solid dose)?

For ubrogepant’s oral tablets, the drug product manufacturing workflow generally includes:

• API blending into tablet formulation (with specified excipients)
• tablet core formation (granulation route or direct compression depending on formulation)
• film coating with controlled dissolution behavior
• in-process controls and finished dose release testing
• blistering/bottling and packaging

Where CMO names come from

• label manufacturing/packaging statements
• contract manufacturing press releases and investor decks
• regulatory submissions and facility registrations that appear in public FDA indexes

What upstream API intermediates and synthesis suppliers support ubrogepant production?

API availability depends on specialized chemical supply chains:

• late-stage intermediates for ubrogepant synthesis
• key reagents and catalysts meeting impurity and residual spec targets
• solvent supply with qualified impurity profile controls

Business use

• For supply assurance, qualify not only the API site, but also the critical intermediate and reagent vendors used to maintain consistent impurity control.
• Require disclosure of route changes and residual impurity monitoring in quality agreements.

What are the regulatory pathways that affect ubrogepant supplier qualification?

• Branded NDA supply: manufacturing changes typically require comparability protocols, CMC updates, and prior approval supplements when needed.
• Generic or authorized alternatives: supply depends on the ANDA approval pathway and bioequivalence performance, and the chosen generic manufacturer’s API source.

For sourcing ubrogepant itself (not generics), the key driver is whether the NDA holder or its CMO controls the release and label-facing manufacturing.

When do ubrogepant suppliers face supply disruption or quality constraints?

Common triggers:

• FDA inspection findings at the labeled manufacturing site
• recall or deviation trends related to coating uniformity, dissolution, or impurity drift
• raw material shortages for key reagents or solvents used in the API route
• site capacity constraints during demand spikes

How to operationalize

• Monitor facility inspection cadence and recall history tied to the labeled sites.
• Maintain at least one qualified alternate API and one qualified alternate drug product capacity plan for commercial continuity.

How does ubrogepant’s competitive landscape impact supplier leverage and sourcing?

Demand for ubrogepant can be affected by:

• competitor CGRP antagonists and gepants in the acute migraine market
• payer formularies and prescribing shifts
• pricing pressures if authorized alternatives or generics enter

When competitors gain share, suppliers often face rebalancing across contracts. That can change:

• which API lots are allocated to each NDA
• manufacturing priorities at tablet CMOs
• available capacity for packaging and labeling

Key takeaways

• Ubrogepant supply chain “suppliers” must be anchored to the manufacturers named on the FDA label and in Orange Book/NDC records for each tablet strength.
• Reliable supplier identification requires facility-level documentation because tablet and packaging are often handled by different entities, and API is frequently sourced from specialized chemical sites.
• Without the specific FDA/NDC/Orange Book firm entries for ubrogepant, a complete and accurate supplier roster cannot be produced.

FAQs

1. How do I find the manufacturer of Ubrelvy tablets for each NDC?
2. Do ubrogepant API and drug product manufacturers differ, and how can you confirm from FDA records?
3. What facility-quality events most often disrupt oral solid drug supply for drugs like ubrogepant?
4. How should procurement teams structure quality agreements for ubrogepant tablets made by CMOs?
5. What does it mean if ubrogepant’s labeled manufacturing site changes between label revisions?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (accessed via FDA Orange Book).
2. FDA. Labeling and prescribing information for Ubrelvy (ubrogepant). (accessed via FDA product labeling pages).
3. FDA. NDC Directory. (accessed via FDA NDC Directory).