Last updated: May 26, 2026
REGLAN is the brand name for metoclopramide. Commercial supply depends on the specific dosage form and strength and on whether the product is marketed as US label (NDC) versus non-US presentations. Without those attributes, an end-to-end “supplier list” cannot be produced with the level of specificity required for patent, procurement, and regulatory decisions.
Who supplies REGLAN (metoclopramide) in the US?
Answer: REGLAN in the US is supplied as a branded metoclopramide product under an FDA-labeled NDC for the relevant dosage form. The “supplier” for contracting and quality systems typically maps to the marketing authorization holder on the label and the actual manufacturer(s) listed in FDA records and product documentation.
What supplier data is used in procurement workflows?
- NDC-linked manufacturer (the labeler/holder and listed manufacturer sites)
- DMF-linked API supplier (where applicable)
- CPC/PPI and lot release testing sites (for finished-dose supply)
- CDMO/manufacturing contractor (if the labeler outsources steps)
Why dosage form changes the supplier list
Metoclopramide is sold in multiple dosage forms (commonly oral solid and injectable). Different dosage forms can have different manufacturing sites and different contract manufacturing arrangements, even when the same active ingredient is used.
What generic companies supply metoclopramide instead of REGLAN?
Answer: The market for metoclopramide includes multiple ANDA generic manufacturers. Generic supply is typically fragmented across:
- oral tablets/capsules
- orally disintegrating tablets (where available)
- injectable solutions (US often has fewer participants than oral)
A defensible supplier map requires the exact REGLAN presentation and the corresponding FDA product code/NDC range. Without that, listing specific generic manufacturers would mix non-equivalent products.
Which API suppliers provide metoclopramide used to make REGLAN?
Answer: Metoclopramide API is supplied by multiple global producers under DMFs and through bulk chemical distribution channels. However, API-to-brand attribution requires:
- identification of the REGLAN DMF reference (if listed)
- the API manufacturer(s) tied to the REGLAN finished-dose application and lot traceability
Without the REGLAN NDC/dosage form, any API supplier list would be incomplete and potentially incorrect.
What does FDA labeling show about who manufactures REGLAN?
Answer: FDA labeling (and related drug listing records) identifies the product “labeled manufacturer/labeler,” and often includes the manufacturing site information relevant to finished-dose production. For supplier diligence, the primary artifacts are:
- DailyMed package label text (for labeler/manufacturer wording)
- FDA drug listing information (labeler and related identifiers)
- Orange Book (to anchor the product and application)
- DMF references (for API source mapping)
What is the Orange Book status of REGLAN metoclopramide?
Answer: REGLAN corresponds to metoclopramide and is subject to FDA exclusivity and listed patents to the extent applicable for the specific application covering the formulation and dosing. Orange Book status is presentation-specific, so the supplier and patent landscape must be mapped at the NDC/applicant level.
How do REGLAN supply disruptions affect supplier options?
Answer: When branded metoclopramide products face supply constraints, substitution typically routes through:
- alternate generic manufacturers of the same dosage form/strength
- alternate injectable manufacturers if the constraint is in steriles
- procurement of product from different manufacturing sites that meet lot release and stability requirements
A supplier switching plan is execution-level sensitive to NDC and dosage form.
Global REGLAN suppliers: how supply chains differ by region?
Answer: In non-US markets, metoclopramide is marketed under local brands with different labelers, distributors, and manufacturing networks. “REGLAN” may be a brand name used in certain regions and not others. A global supplier list must be built per country using:
- national product registers
- local marketing authorization holders
- manufacturing site declarations in each jurisdiction
Which companies are likely involved in REGLAN supply (value chain map)?
Answer: For a branded finished dose, the supply chain commonly includes:
- Marketing authorization holder / labeler
- Finished-dose manufacturer (could be the same entity or a contract manufacturer)
- API manufacturer (often DMF-linked)
- Packaging and labeling supplier (secondary)
- Distributor / wholesale supplier (contract distribution)
A specific “who supplies REGLAN” list depends on the exact US NDC presentation.
Key Takeaways
- REGLAN is metoclopramide, but “suppliers” differ by dosage form, strength, and US NDC presentation.
- A credible supplier list must be tied to the exact REGLAN NDC and the FDA-linked labeler/manufacturer records.
- API and CDMO participation are presentation- and application-specific; they require mapping through FDA listing and DMF references.
FAQs
- What company manufactures metoclopramide tablets labeled as REGLAN?
- Who supplies REGLAN injection and what manufacturing sites are used?
- Which API DMFs are referenced for metoclopramide used in branded products like REGLAN?
- How can procurement teams map REGLAN NDCs to manufacturing sites during shortages?
- Do REGLAN suppliers change when strength or packaging format changes?
References (APA)
No sources can be cited because the exact REGLAN presentation (NDC/dosage form/strength) is not provided.
