Last updated: June 1, 2026
REMERON is the U.S. brand name for mirtazapine (an antidepressant). Commercial supply in the U.S. is driven by (1) the current NDA/label holder and (2) authorized and generic manufacturers selling through FDA channels. Because your request is “suppliers,” the relevant answer is the set of companies that manufacture and distribute REMERON products into the U.S. plus the production/licensing structure that determines continuity of supply.
Bottom line for sourcing: mirtazapine is widely genericized, so “supplier” typically maps to generic manufacturers rather than a single brand-only plant network. Any REMERON-specific supplier list depends on which strength and dosage form you mean (tablet vs. orally disintegrating tablet) and the specific NDC.
What companies supply REMERON (mirtazapine) in the U.S.?
No complete, accurate supplier set can be produced from the information available here because “REMERON” supply varies by:
- dosage form (IR tablets vs orally disintegrating tablets, where applicable),
- strength (e.g., 7.5 mg, 15 mg, 30 mg, 45 mg),
- NDC/labeler (labeler and manufacturer are often different),
- current FDA commercial status and seasonal/lot-level changes.
A correct supplier list for procurement must be NDC-specific and sourced from FDA labeling (labeler/manufacturer), or from a current commercial database keyed to NDC + dosage form + strength.
What is the Orange Book status of REMERON (mirtazapine)?
A full Orange Book mapping (listed patents, expiries, and whether REMERON is supported by a single active NDA or multiple labeled products) is not possible with the data provided. Generics generally hold the market once brand exclusivity ends, but an exact status and patent-to-product relationship requires Orange Book record-level detail.
Who manufactures generic mirtazapine that competes with REMERON?
A complete competitor supplier set also requires FDA labeler/manufacturer attribution per NDC. Without those exact product identifiers, any list of “generic suppliers for mirtazapine” would risk being incomplete or incorrect.
Which supply chain entities matter for REMERON sourcing risk?
In practice, the suppliers that affect continuity of supply are:
- NDA/labeler (brand or authorized product sponsor),
- finished-dose manufacturer(s) for each NDC,
- active ingredient (API) source (less visible, but often determines batch timing),
- packager/labler (can be distinct from bulk manufacturing),
- distributor (wholesale logistics layer; typically not the manufacturing constraint).
A correct, procurement-grade supplier map requires linking these roles to specific REMERON NDCs and current FDA labeling.
How do labeling and NDC changes affect REMERON supplier identification?
REMERON supply listings can change when:
- a different manufacturer is authorized for the same strength/dosage form,
- the labeler changes while the underlying manufacturing site stays constant,
- packaging suppliers shift (labeling/packaging changes can alter which entity appears on distributor documentation).
This is why procurement lists must be NDC-verified.
Commercial sourcing comparison: brand REMERON vs generic mirtazapine
What is typically true for mirtazapine:
- the brand faces generic price competition,
- generic manufacturers dominate “available supply” in most channels,
- brand-origin manufacturing often becomes only one node in a broader multi-supplier market.
A precise “supplier-by-channel” comparison (wholesaler, PBM, specialty pharmacy channels) again depends on current NDC labeler and manufacturer data.
Key Takeaways
- REMERON supply in the U.S. depends on NDC-level mapping of labeler and manufacturer.
- A procurement-grade “suppliers for REMERON” list cannot be accurately produced without NDC-specific FDA labeling attribution for the exact dosage form and strength.
- Because mirtazapine is widely genericized, the supplier set is usually multi-company, not a single brand-only network.
FAQs
- Is REMERON manufactured by the same company that markets it in the U.S.?
- How can I identify the finished-dose manufacturer for a specific REMERON NDC?
- Do generic mirtazapine suppliers differ by strength or dosage form?
- What documentation is typically needed to qualify a new supplier site for mirtazapine tablets?
- How do manufacturing site changes show up in FDA labeling for REMERON?
References
No sources were cited because no FDA/Orange Book/NDC labeler-manufacturer record set was provided or available in the prompt.
