Last updated: May 24, 2026
Austedo (deutetrabenazine) is supplied by Teva Pharmaceuticals in the US. The supply chain for Austedo tablets includes Teva’s manufacturing network and contract manufacturing/packaging partners used for scale and cost. The product’s finalized, commercially used suppliers and facilities are determined through FDA drug-application manufacturing site listings (Orange Book/labeling) and DMF/CMO references tied to the listed NDA.
Who supplies Austedo (deutetrabenazine) in the US?
Answer: Teva Pharmaceuticals is the branded marketer and primary commercial supplier for Austedo in the US, with manufacturing performed across Teva and/or licensed partner facilities listed in the FDA application records and the US product labeling.
What entity is listed as the drug’s manufacturer/sponsor?
- Marketing authorization holder / NDA holder: Teva Pharmaceuticals (US)
- Brand product: Austedo (deutetrabenazine) tablets
How do you identify the actual manufacturing suppliers?
Use the following FDA-linked documents for the exact facility-by-facility supplier list:
- FDA labeling (Highlights + Section 16 and/or “Manufactured for/Distributed by”)
- Orange Book listing for the NDA (ties to approved manufacturers and patents)
- Drug Master Files (DMFs) referenced for excipients/processing
- BLA/NDA manufacturing site disclosures in FDA submissions and inspection databases (for CMO facility naming)
Which contract manufacturing organizations make Austedo tablets?
Answer: The contract manufacturing organizations (CMOs) for Austedo tablets are identified by the approved manufacturing sites referenced in Austedo labeling and FDA application manufacturing information, including Teva plant sites and any external partner facilities used for tablet manufacture, packaging, or release testing.
Common Austedo CMO touchpoints
- Solid oral dosage tablet manufacturing (granulation, compression, coating)
- Primary packaging and NDC serialization
- Secondary packaging and distribution release
Where CMO names show up in practice
- Labeling text that states the product is “Manufactured by” or “Manufactured for” a specific named entity at a specific facility
- FDA’s listed manufacturing sites in product-specific application records
- Inspectional evidence tied to manufacturing locations
Are there multiple Austedo tablet strengths, and do suppliers vary by strength?
Answer: Austedo is marketed in multiple tablet strengths, and manufacturing suppliers can vary by strength if different facilities are qualified for specific dosage presentations or if scale is shifted across plants.
Why strength-level sourcing can differ
- Facility equipment qualification by compression/film-coating parameters
- Batch size and stability constraints
- Packaging-line qualification by NDC configuration
What is the Orange Book status of Austedo, and how does it affect supplier mapping?
Answer: Orange Book listings identify the approved NDA product and can help you map supplier responsibility for the marketed product, but the Orange Book itself is patent-centric. Actual supplier/manufacturing-site names are typically captured in labeling and FDA manufacturing site disclosures.
How Orange Book data is used in supplier due diligence
- Confirm the approved formulation and dosage form tied to the NDA
- Match the NDA product to the listed manufacturers in FDA records
- Cross-check whether any site changes track with patent-protected formulations or manufacturing processes
Who supplies Austedo internationally?
Answer: International supply is typically handled by local affiliates or regional partners of Teva under license, with manufacturing performed by Teva and/or regional contract partners. Facility names vary by country and regulatory dossier.
What to check for each jurisdiction
- National drug registers for “marketing authorization holder” and “manufacturer”
- Product-specific SmPC/labeling for “manufactured by” and “packaged by” sites
- Local inspection history for facility operational confirmation
What generic or authorized-abbreviated suppliers compete with Austedo, and could they displace Teva sourcing?
Answer: Any generic launch or authorized competitor is sourced from the generic marketer’s approved manufacturing facilities. If generics enter, they do not displace Teva’s supply for branded Austedo, but they can reduce volume and shift Teva production planning.
How to anticipate supplier displacement risk
- Timing of ANDA approvals and launch calendars
- Whether Teva keeps exclusivity on formulation/process patents
- Whether payer contracts force supply re-optimization
What manufacturing and IP barriers affect Austedo supply contracts?
Answer: Deutetrabenazine tablet manufacture and scale-up are constrained by:
- Qualified manufacturing sites
- Process validation for tablet production parameters
- Patent-protected formulations and/or manufacturing methods (to the extent they are claimed)
Where IP hits supply
- Process patents can restrict “how” tablets can be made
- Formulation patents can restrict excipient or solid-state/process selections
- Method-of-use patents can restrict labeling and therefore launch sequencing
Key takeaways
- Teva Pharmaceuticals is the branded supplier/sponsor for Austedo in the US.
- The actual manufacturing suppliers and specific CMOs are determined from FDA-linked manufacturing site listings and product labeling that name the “manufactured for/at” entities and facility addresses.
- Supplier variation by strength can occur if different qualified manufacturing and packaging lines are used.
- Orange Book is mainly patent-centric; supplier identification is best done through labeling + FDA manufacturing-site disclosures and facility-linked records.
FAQs
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How do I find the specific manufacturer name listed on Austedo tablet packaging?
Check the US prescribing information labeling and the “Manufactured for/Distributed by” section tied to the Austedo NDC.
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Do Austedo tablets use different manufacturers for different NDCs?
Yes, manufacturing and packaging can differ by NDC configuration if separate qualified sites are used.
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Can a contract manufacturer be replaced for Austedo without changing the Orange Book entry?
Often yes; Orange Book listings do not always reflect manufacturing-site swaps unless formulation/process claims are implicated.
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What FDA records show Austedo manufacturing facilities and site changes?
FDA label/manufacturing sections, Orange Book-linked application records, and facility-specific FDA inspection and submission traces.
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Will generic deutetrabenazine competitors use the same suppliers as Teva?
Typically no; generics use their own approved manufacturers, unless an authorized-license supply arrangement exists.
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
- FDA. Drugs@FDA: Austedo (deutetrabenazine) application and labeling records. U.S. Food and Drug Administration.
- Teva Pharmaceuticals. Austedo (deutetrabenazine) prescribing information and US labeling (manufacturer/distributor text).
- FDA. Drug Master Files (DMF) database and related application references (where applicable). U.S. Food and Drug Administration.
