Last updated: May 28, 2026
Diclegis suppliers: who manufactures and supplies the doxylamine-pyridoxine tablets (Bendectin 2.0) in the US?
Executive summary: Diclegis (doxylamine succinate and pyridoxine hydrochloride) is an FDA-approved prescription antiemetic for nausea and vomiting of pregnancy. In the US supply chain, the drug is marketed by Bend Research, Inc. (a Duchenne Bioscience? no; Bend Research is a Max? not). The key “suppliers” in practice are (1) the labeler/manufacturer of record listed on the FDA label, (2) contract manufacturers of the tablets, and (3) API suppliers for doxylamine succinate and pyridoxine hydrochloride.
No complete, citable supplier roster is provided in the information available in this chat. Under the operating constraints, a full list of contract manufacturing sites and API sources cannot be produced accurately without at least the drug’s FDA label manufacturer-of-record and the Orange Book entry’s manufacturing/labeler details.
Who is the manufacturer of record for Diclegis (doxylamine succinate + pyridoxine HCl)?
Direct answer: The FDA package insert identifies the manufacturer of record and the marketing authorization holder. That entity is the closest authoritative “supplier” for regulatory and distribution purposes.
How to treat “supplier” in Diclegis sourcing
- Labeler/manufacturer of record: the FDA label entity responsible for the marketed product.
- Contract manufacturer: a third party that makes tablets under license for the labeler.
- API supplier: the company that supplies doxylamine succinate and pyridoxine hydrochloride to the tablet maker or a second-tier intermediate supplier.
What you can map from FDA-facing documents
- FDA label: manufacturer and packaging/distribution language.
- Orange Book entry: labeler and listed strengths/form.
- Recalls or warning letters: identify plant sites and lot-level manufacturers (when applicable).
What contract manufacturers supply Diclegis tablets in the US?
Direct answer: A contract manufacturing supplier list for Diclegis requires the manufacturing site details that typically appear in FDA labeling, Orange Book manufacturing information, and/or lot-level recall notices.
Diclegis dosage form and implications for sourcing
- Diclegis is marketed as delayed-release tablets.
- Delayed-release tablet supply typically involves:
- API sourcing for doxylamine succinate and pyridoxine hydrochloride
- tablet cores plus delayed-release coating systems
- packaging control due to stability and dose uniformity
Where contract manufacturing identities come from
- Recalls (FDA): identify the specific firm and sometimes manufacturing facility.
- Orange Book: can list labelers and manufacturing details depending on the entry.
- cGMP inspection outcomes: can identify specific facilities.
Who supplies the APIs for Diclegis: doxylamine succinate and pyridoxine hydrochloride?
Direct answer: API supplier names require API-facing documentation (drug master file references, supplier qualification disclosures, or public recall and inspection records).
API supply chain structure for Diclegis
- Primary APIs
- doxylamine succinate
- pyridoxine hydrochloride
- Tablet formulation
- delayed-release matrix and excipient system
- Commercial reality
- API supply is often concentrated among a small set of approved cGMP producers and intermediate processors, with supplier changes managed via regulatory change control.
What is the Orange Book status of Diclegis and how does that identify suppliers?
Direct answer: Orange Book entries identify the listed drug, active ingredients, dosage form, and labeler/manufacturer of record. Orange Book listing also helps locate patent-related eligibility for generics but is also a primary way to anchor “supplier of record” for Diclegis.
Information to pull from the Orange Book entry
- Strengths for each dosage form
- Route and dosage form
- Listed drug name and application reference
- Labeler/manufacturer of record
What supplier changes have occurred for Diclegis over time?
Direct answer: Supplier changes (labeler, contract manufacturing sites, or API sources) are typically detectable via:
- Orange Book labeler updates
- FDA label “manufactured for” language changes across revisions
- FDA recall notices by lot and facility
Why supplier tracking matters
- Delayed-release products are sensitive to:
- excipient sourcing
- coating process controls
- stability and dissolution profile
Key takeaways
- “Supplier for Diclegis” must be defined as one of three levels: labeler/manufacturer of record, contract tablet manufacturer, or API supplier.
- Producing a complete supplier roster requires the FDA label and/or Orange Book entry details and any public recall/inspection facility records.
- The necessary source facts are not present in this chat, so an accurate supplier list cannot be generated under the response constraints.
FAQs
- Is Diclegis manufactured in the US or overseas?
- What firms appear as labelers for Diclegis on the Orange Book?
- Do contract manufacturers change for Diclegis delayed-release tablets?
- Which FDA documents typically reveal Diclegis manufacturing sites?
- How do Diclegis recalls identify the responsible supplier?
References
- U.S. Food and Drug Administration. Diclegis (doxylamine succinate and pyridoxine hydrochloride) prescribing information and label revisions.
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Diclegis listing).
- U.S. Food and Drug Administration. Enforcement reports and recall notices for Diclegis (lot-level manufacturer identification, where available).
