Last updated: June 2, 2026
Orladeyo (berotralstat) is supplied through a narrowly defined manufacturing chain tied to branded product registration and ongoing FDA oversight. The supplier picture for Orladeyo depends on (1) the identity of the labeled manufacturer(s) on the U.S. prescribing information and (2) the facility-level manufacturing listings in the FDA’s Orange Book and Drug Establishment Registration and Listing (DERL).
No extractable, citable supplier roster (named contract manufacturers, API suppliers, solid-dose packaging sites, or specific facility addresses) is available in the information provided in this prompt. Per the operating constraints, a complete and accurate supplier list cannot be produced without those source facts.
Which companies supply Orladeyo (berotralstat) in the US market?
Answer: Not determinable from the provided inputs.
What supplier data does Orladeyo labeling typically expose?
Answer: The labeled manufacturing chain in the U.S. prescribing information generally identifies:
- Marketing authorization holder and U.S. contact
- Drug product manufacturer(s)
- Packaging/labeling manufacturer(s)
- If applicable, separate sites for dosage form manufacture, bottling/packing, and distribution
Where does FDA publish facility-level supplier identity for Orladeyo?
Answer: Facility-level suppliers are typically found in:
- FDA Orange Book listings (application, NDA labeling, and sometimes manufacturing/labeler data)
- FDA DERL (registration and listing by facility)
- FDA inspection database entries tied to the approved application (site and scope)
What is the Orladeyo (berotralstat) API supplier chain?
Answer: Not determinable from the provided inputs.
Does Orladeyo use a single API supplier or multiple sources?
Answer: Not determinable.
How are berotralstat bulk API and intermediates usually governed?
Answer: API and intermediate manufacturing are governed by:
- Approved Chemistry, Manufacturing, and Controls (CMC) sections in the NDA
- Site change notifications/approvals for additional manufacturing locations
- Specifications and validated processes for impurity control and polymorph/particle profile (as applicable)
Who manufactures Orladeyo drug product tablets and packages them for sale?
Answer: Not determinable from the provided inputs.
What site-level roles matter for tablet supply?
Answer: Tablet supply risk usually concentrates in:
- Solid-dose tablet manufacturing (blending, granulation if applicable, compression, coating if applicable)
- Finished dosage release testing and stability management
- Primary packaging (bottles/blister and desiccant)
- Secondary packaging and labeling
What is the Orange Book status of Orladeyo and what does it imply for suppliers?
Answer: Not determinable from the provided inputs.
How does Orange Book labeling affect supplier identification?
Answer: Orange Book can confirm:
- NDA/application identifier(s) under which the product is marketed
- Listed active ingredient(s)
- Listed dosage forms and strengths
- Patent and exclusivity items that often correlate with controlled manufacturing and site change constraints
Which contract manufacturing organizations could support Orladeyo under FDA oversight?
Answer: Not determinable from the provided inputs.
How to interpret “could support” versus confirmed suppliers
Answer: Only named entities from FDA-anchored sources (labeler/manufacturer listed in labeling, Orange Book, DERL) are supplier confirmations. Without those facts in the prompt, the supplier set cannot be stated.
What supplier risks affect Orladeyo continuity of supply?
Answer: Not determinable from the provided inputs.
Common continuity-of-supply risk points for oral solid-dose drugs
Answer: For tablet products, continuity risks usually include:
- Single-site manufacturing dependence
- Equipment or validated process bottlenecks
- Stability/pack-out constraints (shelf-life linked to packaging configuration)
- Regulatory impacts from manufacturing changes (CMC supplements, comparability)
How many manufacturers supply Orladeyo globally?
Answer: Not determinable from the provided inputs.
Global supplier structure can differ from the US
Answer: A sponsor may use different manufacturing sites for different markets. A US-labeled supplier list may not map 1:1 to EU/UK supply chains.
Key Takeaways
- A verified supplier map for Orladeyo (berotralstat) cannot be produced from the information provided.
- A complete answer requires source-anchored identification from Orladeyo’s U.S. labeling and FDA facility/regulatory listings; those source facts are not present in the prompt.
FAQs
- Who is the Orladeyo (berotralstat) labeled manufacturer in the US prescribing information? Not determinable from the provided inputs.
- Is berotralstat supplied from a single API manufacturer or multiple sites? Not determinable from the provided inputs.
- Which FDA facility registrations typically indicate Orladeyo manufacturing sites? Not determinable from the provided inputs.
- Do Orladeyo tablet packaging suppliers differ from tablet manufacturing suppliers? Not determinable from the provided inputs.
- What Orange Book data fields are most useful for identifying Orladeyo’s supply chain entities? Not determinable from the provided inputs.
References (APA)
- Not available from the provided inputs.
